Last data update: May 06, 2024. (Total: 46732 publications since 2009)
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Query Trace: Goswami ND[original query] |
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Notes from the field: Undiagnosed tuberculosis during pregnancy resulting in a neonatal death - United States, 2021
Miele K , Rock RB , LaCourse SM , Ashkin D , Armitige LY , Pomputius W , Goswami ND . MMWR Morb Mortal Wkly Rep 2023 72 (49) 1331-1332 In 2022, the World Health Organization reported 10.6 million new cases of tuberculosis (TB) globally. One third of these new cases were reported in women; however, pregnancy status was not included in these data.* CDC recently added pregnancy status to national TB reporting in the United States; however, because the number of U.S. TB cases during pregnancy is presumed to be low, adverse effects of TB on pregnancy and postpartum outcomes are likely not well characterized.† A 2017 meta-analysis of 13 studies that included approximately 123,000 pregnancies from several countries found that TB disease during pregnancy was associated with increased odds of maternal morbidity and mortality, including hospital admission, anemia of pregnancy, cesarean birth, miscarriage, preterm birth, low birthweight, and neonatal TB (1). TB diagnosis during pregnancy might be delayed because of overlap in symptoms of TB with those of pregnancy, as well as clinician reluctance to use chest radiography during pregnancy.§ Perinatal TB is a life-threatening illness, with a congenital and neonatal TB mortality rate of approximately 50% (2), highlighting the importance of diagnosing and treating TB before and during pregnancy. This report describes a case of fatal neonatal TB after successful in vitro fertilization in 2021. |
Bedaquiline, pretomanid, and linezolid with or without moxifloxacin for tuberculosis
Labuda SM , Seaworth B , Dasgupta S , Goswami ND . Lancet Respir Med 2023 An all-oral, 6-month regimen of bedaquiline, pretomanid, and linezolid (BPaL) was approved by the US Food and Drug Administration (FDA) in the USA for the treatment of some forms of multidrug-resistant tuberculosis in 2019.1 The USA has a low incidence of tuberculosis, with 2·5 cases diagnosed per 100 000 population and 90 cases of multidrug-resistant tuberculosis reported in 2022. In February, 2022, the US Centers for Disease Control and Prevention (CDC) published initial guidance for the use of BPaL. In December, 2022, based on results from a subsequent international randomised trial,2 WHO recommended an alternative regimen—bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM)—for all patients with multidrug-resistant tuberculosis without fluoroquinolone resistance.3 Here we present data from all patients reported to the CDC as initiating the BPaLM regimen in the USA between Aug 14, 2019, and Dec 31, 2022, and from patients receiving BPaL, a regimen previously documented to have uptake in US tuberculosis programmes,4, 5 as a complement to the randomised TB-PRACTECAL study.6 | | US public health jurisdictions were invited to submit standardised, de-identified data for each patient receiving BPaL or BPaLM. Between Aug 14, 2019, and Dec 31, 2022, 116 patients started treatment with BPaL and 36 with BPaLM in 19 US states and territories (table). The majority of patients for whom data were available (103 [90%] of 114) started with linezolid 600 mg daily; 42 (37%) of these 114 patients had their doses of linezolid adjusted during treatment. Of the 113 (74%) of 152 patients who were reported to have completed treatment, none had their therapy terminated. The most common side-effect in both regimens was peripheral neuropathy, which could have occurred as a result of linezolid or previous tuberculosis medications received by the patient. As of June 30, 2023—26 weeks after the end of the monitoring period—one patient required additional medication in a prolonged regimen after BPaL treatment failure, three had their baseline treatment extended owing to delayed culture clearance, three had a relapse of tuberculosis, and four patients died. 84 (72%) of 116 patients who received BPaL and 29 (81%) of 36 patients who received BPaLM reported treatment completion. |
Adverse events among persons with TB using in-person vs. electronic directly observed therapy
Salerno MM , Burzynski J , Mangan JM , Hill A , deCastro BR , Goswami ND , Lam CK , Macaraig M , Schluger NW , Vernon AA . Int J Tuberc Lung Dis 2023 27 (11) 833-840 BACKGROUND: We evaluated patient safety within a randomized crossover trial comparing electronic directly observed therapy (eDOT) to in-person DOT (ipDOT) in persons undergoing TB treatment in New York City, NY, USA.METHODS: Participant symptoms, symptom severity, and clinical management were documented. We assessed adverse event reports (AERs) by DOT method during the two-period crossover. Using Cox proportional-hazards mixed-effects models, we estimated the adjusted hazard ratio (aHR) of participants reporting an adverse event (AE) vs. not reporting an AE.RESULTS: Of 211 participants, 57 (27.0%) reported AEs during the two-period crossover; of these, 54.4% (31/57) were reported while using eDOT vs. 45.6% (26/57) while using ipDOT. Controlling for study group and period, the aHR for eDOT vs. ipDOT was 0.98 (95% CI 0.49-1.93). Although statistically not significant, the wide confidence intervals suggest that a significant association cannot be entirely ruled out. Gastrointestinal symptoms were most frequently reported (42.1%, 24/57). AER types and severity did not differ significantly by DOT method. Days from symptom onset to medical attention was similar across DOT methods (median: 1.0 day, IQR 0.0-2.0). No participants switched DOT methods due to AERs or monitoring concerns.CONCLUSION: Further evaluation to ascertain whether AERs differ when patients use eDOT vs. ipDOT is warranted. |
Characteristics of and deaths among 333 persons with tuberculosis and COVID-19 in cross-sectional sample from 25 jurisdictions, United States
Nabity SA , Marks SM , Goswami ND , Smith SR , Timme E , Price SF , Gross L , Self JL , Toren KG , Narita M , Wegener DH , Wang SH . Emerg Infect Dis 2023 29 (10) 2016-2023 Little is known about co-occurring tuberculosis (TB) and COVID-19 in low TB incidence settings. We obtained a cross-section of 333 persons in the United States co-diagnosed with TB and COVID-19 within 180 days and compared them to 4,433 persons with TB only in 2020 and 18,898 persons with TB during 2017‒2019. Across both comparison groups, a higher proportion of persons with TB-COVID-19 were Hispanic, were long-term care facility residents, and had diabetes. When adjusted for age, underlying conditions, and TB severity, COVID-19 co-infection was not statistically associated with death compared with TB infection only in 2020 (adjusted prevalence ratio 1.0 [95% CI 0.8‒1.4]). Among TB-COVID-19 patients, death was associated with a shorter interval between TB and COVID-19 diagnoses, older age, and being immunocompromised (non-HIV). TB-COVID-19 deaths in the United States appear to be concentrated in subgroups sharing characteristics known to increase risk for death from either disease alone. |
Implementation of BPaL in the United States: Experience using a novel all-oral treatment regimen for treatment of rifampin-resistant or rifampin-intolerant TB disease
Haley CA , Schechter MC , Ashkin D , Peloquin CA , Cegielski JP , Andrino BB , Burgos M , Caloia LA , Chen L , Colon-Semidey A , DeSilva MB , Dhanireddy S , Dorman SE , Dworkin FF , Hammond-Epstein H , Easton AV , Gaensbauer JT , Ghassemieh B , Gomez ME , Horne D , Jasuja S , Jones BA , Kaplan LJ , Khan AE , Kracen E , Labuda S , Landers KM , Lardizabal AA , Lasley MT , Letzer DM , Lopes VK , Lubelchek RJ , Macias CP , Mihalyov A , Misch EA , Murray JA , Narita M , Nilsen DM , Ninneman MJ , Ogawa L , Oladele A , Overman M , Ray SM , Ritger KA , Rowlinson MC , Sabuwala N , Schiller TM , Schwartz LE , Spitters C , Thomson DB , Tresgallo RR , Valois P , Goswami ND . Clin Infect Dis 2023 77 (7) 1053-1062 BACKGROUND: Rifampin-resistant tuberculosis is a leading cause of morbidity worldwide; only one-third of persons initiate treatment and outcomes are often inadequate. Several trials demonstrate 90% efficacy using an all-oral, six-month regimen of bedaquiline, pretomanid, and linezolid (BPaL), but significant toxicity occurred using 1200 mg linezolid. After U.S. FDA approval in 2019, some U.S. clinicians rapidly implemented BPaL using an initial linezolid 600 mg dose adjusted by serum drug concentrations and clinical monitoring. METHODS: Data from U.S. patients treated with BPaL between 10/14/2019 and 4/30/2022 were compiled and analyzed by the BPaL Implementation Group (BIG), including baseline examination and laboratory, electrocardiographic, and clinical monitoring throughout treatment and follow-up. Linezolid dosing and clinical management was provider-driven, and most had linezolid adjusted by therapeutic drug monitoring (TDM). RESULTS: Of 70 patients starting BPaL, two changed to rifampin-based therapy, 68 (97.1%) completed BPaL, and two of these 68 (2.9%) patients relapsed after completion. Using an initial 600 mg linezolid dose daily adjusted by TDM and careful clinical and laboratory monitoring for side effects, supportive care, and expert consultation throughout BPaL treatment, three (4.4%) patients with hematologic toxicity and four (5.9%) with neurotoxicity required a change in linezolid dose or frequency. The median BPaL duration was 6 months. CONCLUSIONS: BPaL has transformed treatment for rifampin-resistant or intolerant tuberculosis. In this cohort, effective treatment required less than half the duration recommended in ATS/CDC/ERS/IDSA 2019 guidelines for drug-resistant tuberculosis. Use of individualized linezolid dosing and monitoring likely enhanced safety and treatment completion. The BIG cohort demonstrates that early implementation of new tuberculosis treatments in the U.S. is feasible. |
Fluoroquinolone-resistant latent tuberculosis infection: A literature review and case series of 5 patients treated with linezolid monotherapy
Baker JJ , Nahar R , Petroelje BK , Goswami ND , Lardizabal AA . J Clin Tuberc Other Mycobact Dis 2023 32 100376 Latent tuberculosis infection (LTBI) constitutes an important public health problem because of risk of progression to TB disease. Effective treatment of multi-drug resistant (MDR) LTBI would prevent progression to MDR TB disease, which would improve patient and public health outcomes. The majority of MDR LTBI treatment studies have focused on the use of fluoroquinolone-based antibiotic regimens. Options for and experience in the treatment of fluoroquinolone-resistant MDR LTBI are limited in the published literature and not comprehensively addressed in current guidelines. In this review, we share our experience with the treatment of fluoroquinolone-resistant MDR LTBI with linezolid. We discuss treatment options for MDR TB that provide context for predicting effective MDR LTBI treatment, with a focus on the microbiologic and pharmacokinetic properties of linezolid that support its use. We then summarize the evidence for treatment of MDR LTBI. Finally, we present our experiences treating fluoroquinolone-resistant MDR LTBI with linezolid with an emphasis on dosing considerations to optimize efficacy and minimize potential toxicities. |
Challenges associated with electronic and in-person directly observed therapy during a randomized trial
Mangan JM , Burzynski J , deCastro BR , Salerno MM , Lam CK , Macaraig M , Reaves M , Kiskadden-Bechtel S , Bowers S , Sathi C , Dias MP , Goswami ND , Vernon A . Int J Tuberc Lung Dis 2023 27 (4) 298-307 BACKGROUND: Electronic directly observed therapy (eDOT) has been proposed as an alternative to traditional in-person DOT (ipDOT) for monitoring TB treatment adherence. Information about the comparative performance and implementation of eDOT is limited.METHODS: The frequency of challenges during DOT, challenge type, and effect on medication observation were documented by DOT method during a crossover, noninferiority randomized controlled trial. A logistic mixed-effects model that adjusted for the study design was used to estimate the percentage of successfully observed doses when challenges occurred.RESULTS: A total of 20,097 medication doses were scheduled for observation with either eDOT (15,405/20,097; 76.7%) or ipDOT (4,692/20,097; 23.3%) for 213 study participants. In total, one or more challenges occurred during 17.3% (2,672/15,405) of eDOT sessions and 15.6% (730/4,692) of ipDOT sessions. Among 4,374 documented challenges, 27.3% (n = 1,192) were characterized as technical, 65.9% (n = 2,881) were patient-related, and 6.9% (n = 301) were program-related. Estimated from the logistic model (n = 6,782 doses, 173 participants), the adjusted percentage of doses successfully observed during problematic sessions was 21.7% (95% CI 11.2-37.8) for eDOT and 4.2% (95% CI 1.1-14.7) for ipDOT.CONCLUSION: Compared to ipDOT, challenges were encountered in a slightly higher percentage of eDOT sessions but were more often resolved to enable successful dose observation during problematic sessions. |
Factors associated with receiving longer than recommended therapy among culture-negative pulmonary tuberculosis patients
Tsang CA , Patel NN , Stout JE , Fernando R , Pratt R , Goswami ND . Open Forum Infect Dis 2022 9 (12) ofac630 BACKGROUND: US tuberculosis (TB) guidelines recommend treatment ≥6 months with a regimen composed of multiple effective anti-TB drugs. Since 2003, a 4-month regimen for a specific subset of TB patients has also been recommended. METHODS: We used 2011-2018 US National Tuberculosis Surveillance System data to characterize factors associated with 4-month (111-140 days) therapy among adult patients who had completed treatment and were potentially eligible at that time for 4-month therapy (culture-negative pulmonary-only TB, absence of certain risk factors, and initial treatment that included pyrazinamide). We used modified Poisson regression with backward elimination of main effect variables to calculate adjusted relative risks (aRRs). RESULTS: During 2011-2018, 63 393 adults completed TB treatment: 5560 (8.8%) were potentially eligible for 4-month therapy; of these, 5560 patients (79%) received >4-month therapy (median, 193 days or ∼6 months). Patients with cavitary disease were more likely to receive >4-month therapy (aRR, 1.10; 95% CI, 1.07-1.14) vs patients without cavitary disease. Patients more likely to receive 4-month therapy included patients treated by health departments vs private providers only (aRR, 0.94; 95% CI, 0.91-0.98), those in the South and West vs the Midwest, non-US-born persons (aRR, 0.95; 95% CI, 0.91-0.99) vs US-born persons, and aged 25-64 years vs 15-24 years. CONCLUSIONS: Most patients potentially eligible for 4-month therapy were treated with standard 6-month courses. Beyond clinical eligibility criteria, other patient- and program-related factors might be more critical determinants of treatment duration. |
Pretomanid in the treatment of patients with tuberculosis in the United States
Goswami ND , Ashkin D , Haley CA . N Engl J Med 2022 387 (9) 850-852 According to the Centers for Disease Control and Prevention (CDC), 524 cases of multidrug-resistant (MDR) tuberculosis were reported in the United States (including U.S. territories and freely associated states) for the period from 2014 through 2018. These included 443 cases of tuberculosis that was resistant to isoniazid and rifampin only, 72 cases in which there was additional resistance to either a quinolone or an injectable medication (pre–extensively drug-resistant [XDR] tuberculosis), and 9 cases in which there was additional resistance to both a quinolone and an injectable antituberculosis medication (XDR tuberculosis).1 Of 518 patients with MDR tuberculosis who were alive at the time of diagnosis, 8% died before completing treatment and 38% did not complete treatment within 18 to 24 months after treatment initiation. |
Association of tumor necrosis factor inhibitor use with diagnostic features and mortality of tuberculosis in the United States, 2010-2017
Katrak SS , Li R , Reynolds S , Marks SM , Probst JR , Chorba T , Winthrop K , Castro KG , Goswami ND . Open Forum Infect Dis 2022 9 (2) ofab641 BACKGROUND: An elevated risk of tuberculosis (TB) disease in persons who have received tumor necrosis factor alpha inhibitor medications (TNF- inhibitors) has been reported for nearly two decades, but clinical diagnostic features and outcomes of TB in this population remain poorly described. METHODS: We analyzed national surveillance data for TB cases among persons aged 15 years and older reported in the United States during 2010-2017 and associated mortality data reported through 2019 to describe the clinical characteristics of those receiving TNF- inhibitors. RESULTS: Of 70129 TB cases analyzed, 504 (0.7%) of the patients had TNF- inhibitor use reported at TB diagnosis. Patients with TNF- inhibitor use at TB diagnosis were more likely than TB patients not receiving TNF- inhibitors to have TB diagnosed in extrapulmonary sites in conjunction with pulmonary sites (28.8% vs 10.0%, P<.001). Patients receiving TNF- inhibitors were less likely to have acid-fast bacilli noted on sputum smear microscopy (25.6% vs 39.1%, P=.04), and more likely to have drug-resistant disease (13.5% vs 10.0%, P<.001). TB-attributed deaths did not significantly differ between patients receiving and not receiving TNF- inhibitors (adjusted odds ratio, 1.46 [95% confidence interval, .95-2.26]). CONCLUSIONS: Clinicians evaluating TNF- inhibitor-treated patients should have a high index of suspicion for TB and be aware that extrapulmonary or sputum smear-negative TB disease is more common in these patients. No significantly diminished survival of TB patients treated with TNF- inhibitor therapy before TB diagnosis was noted. |
In-person vs electronic directly observed therapy for tuberculosis treatment adherence: A randomized noninferiority trial
Burzynski J , Mangan JM , Lam CK , Macaraig M , Salerno MM , deCastro BR , Goswami ND , Lin CY , Schluger NW , Vernon A . JAMA Netw Open 2022 5 (1) e2144210 IMPORTANCE: Electronic directly observed therapy (DOT) is used increasingly as an alternative to in-person DOT for monitoring tuberculosis treatment. Evidence supporting its efficacy is limited. OBJECTIVE: To determine whether electronic DOT can attain a level of treatment observation as favorable as in-person DOT. DESIGN, SETTING, AND PARTICIPANTS: This was a 2-period crossover, noninferiority trial with initial randomization to electronic or in-person DOT at the time outpatient tuberculosis treatment began. The trial enrolled 216 participants with physician-suspected or bacteriologically confirmed tuberculosis from July 2017 to October 2019 in 4 clinics operated by the New York City Health Department. Data analysis was conducted between March 2020 and April 2021. INTERVENTIONS: Participants were asked to complete 20 medication doses using 1 DOT method, then switched methods for another 20 doses. With in-person therapy, participants chose clinic or community-based DOT; with electronic DOT, participants chose live video-conferencing or recorded videos. MAIN OUTCOMES AND MEASURES: Difference between the percentage of medication doses participants were observed to completely ingest with in-person DOT and with electronic DOT. Noninferiority was demonstrated if the upper 95% confidence limit of the difference was 10% or less. We estimated the percentage of completed doses using a logistic mixed effects model, run in 4 modes: modified intention-to-treat, per-protocol, per-protocol with 85% or more of doses conforming to the randomization assignment, and empirical. Confidence intervals were estimated by bootstrapping (with 1000 replicates). RESULTS: There were 173 participants in each crossover period (median age, 40 years [range, 16-86 years]; 140 [66%] men; 80 [37%] Asian and Pacific Islander, 43 [20%] Black, and 71 [33%] Hispanic individuals) evaluated with the model in the modified intention-to-treat analytic mode. The percentage of completed doses with in-person DOT was 87.2% (95% CI, 84.6%-89.9%) vs 89.8% (95% CI, 87.5%-92.1%) with electronic DOT. The percentage difference was -2.6% (95% CI, -4.8% to -0.3%), consistent with a conclusion of noninferiority. The 3 other analytic modes yielded equivalent conclusions, with percentage differences ranging from -4.9% to -1.9%. CONCLUSIONS AND RELEVANCE: In this trial, the percentage of completed doses under electronic DOT was noninferior to that under in-person DOT. This trial provides evidence supporting the efficacy of this digital adherence technology, and for the inclusion of electronic DOT in the standard of care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03266003. |
The Advisory Committee on Immunization Practices' Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines - United States, 2021.
Mbaeyi S , Oliver SE , Collins JP , Godfrey M , Goswami ND , Hadler SC , Jones J , Moline H , Moulia D , Reddy S , Schmit K , Wallace M , Chamberland M , Campos-Outcalt D , Morgan RL , Bell BP , Brooks O , Kotton C , Talbot HK , Lee G , Daley MF , Dooling K . MMWR Morb Mortal Wkly Rep 2021 70 (44) 1545-1552 Three COVID-19 vaccines are currently approved under a Biologics License Application (BLA) or authorized under an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) and recommended for primary vaccination by the Advisory Committee on Immunization Practices (ACIP) in the United States: the 2-dose mRNA-based Pfizer-BioNTech/Comirnaty and Moderna COVID-19 vaccines and the single-dose adenovirus vector-based Janssen (Johnson & Johnson) COVID-19 vaccine (1,2) (Box 1). In August 2021, FDA amended the EUAs for the two mRNA COVID-19 vaccines to allow for an additional primary dose in certain immunocompromised recipients of an initial mRNA COVID-19 vaccination series (1). During September-October 2021, FDA amended the EUAs to allow for a COVID-19 vaccine booster dose following a primary mRNA COVID-19 vaccination series in certain recipients aged ≥18 years who are at increased risk for serious complications of COVID-19 or exposure to SARS-CoV-2 (the virus that causes COVID-19), as well as in recipients aged ≥18 years of Janssen COVID-19 vaccine (1) (Table). For the purposes of these recommendations, an additional primary (hereafter additional) dose refers to a dose of vaccine administered to persons who likely did not mount a protective immune response after initial vaccination. A booster dose refers to a dose of vaccine administered to enhance or restore protection by the primary vaccination, which might have waned over time. Health care professionals play a critical role in COVID-19 vaccination efforts, including for primary, additional, and booster vaccination, particularly to protect patients who are at increased risk for severe illness and death. |
Challenges in LTBI care in the United States identified using a nationwide TB medical consultation database
Agathis NT , Bhavaraju R , Shah V , Chen L , Haley CA , Goswami ND , Patrawalla A . Public Health Action 2021 11 (3) 162-166 BACKGROUND: Identifying and treating individuals with latent TB infection (LTBI) represents a critical and challenging component of national TB elimination. Medical consultations by the Centers for Disease Control and Prevention (CDC) funded TB Centers of Excellence (COEs) are an important resource for healthcare professionals (HCPs) caring for individuals with LTBI. This study aimed to identify the most common clinical concerns regarding LTBI care and to describe epidemiologic and clinical features of patients discussed in these consultations. METHODS: This mixed-methods study randomly sampled 125 consultation inquiries related to LTBI from the COEs' medical consultation database in 2018. Text from consultation records were reviewed and coded to identify reasons for the inquiries and common epidemiologic and clinical patient characteristics. RESULTS: The most common topics of inquiry for consultation included accurate LTBI diagnosis (36%), management of LTBI treatment-related issues (22%), and choice of appropriate LTBI treatment regimen (17%). Patients for whom consultations were requested commonly had another medical condition (34%), were non-U.S. born (31%), were children (25%), and had a history of travel to TB-endemic areas (18%). CONCLUSION: Our findings emphasize the challenge of managing patients with either suspected or confirmed LTBI, highlighting the need for ongoing medical consultation support for nuanced clinical and epidemiologic scenarios. |
Delayed Tuberculosis Diagnoses During the COVID-19 Pandemic in 2020 - King County, Washington.
Narita M , Hatt G , Toren KG , Vuong K , Pecha M , Jereb JA , Goswami ND . Clin Infect Dis 2021 73 S74-S76 In 2020, a total of 92 tuberculosis (TB) cases were reported in Seattle and King County, Washington, 5% fewer than the median of 97 (range = 94 –132) reported during the same period 2015–2019 and 30% fewer than 132 cases reported in 2019. Interviews and chart reviews were completed as part of a public health investigation. This activity was reviewed by Centers for Disease Control and Prevention (CDC) and was conducted consistent with applicable federal law and CDC policy. Results for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests performed prior to TB diagnosis were available to TB public health officials for 40 (43%) patients with TB: 3 had a positive result; 37 had negative results, with 12 having been tested twice or more. We were not able to verify SARS-CoV-2 testing status or results prior to TB diagnosis for 52 TB cases. We attempted to reach out to all pulmonary TB cases diagnosed in March 2020 or later and were able to interview 29 patients by telephone or in person about how pandemic coronavirus disease 2019 (COVID-19) affected their medical care. Four of them stated that their TB diagnosis had been delayed because of pandemic-related problems. Of these, 3 waited to seek care because of fear of contracting COVID-19, and one, patient 1, was told that she probably had COVID-19 by at least 2 healthcare providers. The stories of the following 3 patients who had prolonged respiratory illnesses with fever illustrate the delays in TB diagnosis during the COVID-19 pandemic. |
Evidence, Experience, Expertise, and the U.S. COVID-19 Public Health Response.
Goswami ND , Fiore AE , Walke HT . Clin Infect Dis 2021 73 S1-S4 The U.S. Centers for Disease Control and Prevention (CDC), state, tribal, and local health departments assess available and promising interventions and individual and population health outcomes when crafting public health recommendations. This supplement provides a snapshot of some of the science, experience, and expertise supporting the COVID-19 response. |
Novel 6-month treatment for drug-resistant tuberculosis, United States
Haley CA , Macias P , Jasuja S , Jones BA , Rowlinson MC , Jaimon R , Onderko P , Darnall E , Gomez ME , Peloquin C , Ashkin D , Goswami ND . Emerg Infect Dis 2021 27 (1) 332-4 The US Food and Drug Administration approved a 6-month regimen of pretomanid, bedaquiline, and linezolid for extensively drug-resistant or multidrug-intolerant tuberculosis after a trial in South Africa demonstrated 90% effectiveness 6 months posttreatment. We report on a patient who completed the regimen using a lower linezolid dose. |
Linezolid use for the treatment of multidrug-resistant tuberculosis, TB centers of excellence, United States, 2013-2018
McDowell A , Haas M , Seaworth B , Wilson JW , Patrawalla A , Haley C , Lauzardo M , de Bruyn M , Goswami ND . J Clin Tuberc Other Mycobact Dis 2021 22 100201 BACKGROUND: In 2019, the World Health Organization released guidelines reflecting major changes in multidrug-resistant tuberculosis (MDR-TB) management-prioritizing fluoroquinolones, bedaquiline, and linezolid (LZD) while de-emphasizing previously favored injectable agents. In some cases, linezolid use is associated with gastrointestinal intolerance, mitochondrial toxicity, and significant drug interactions. CDC's Division of Tuberculosis Elimination supports a network of regional TB Centers of Excellence, which provide medical consultation to healthcare providers. Consultations are documented in a medical consultation database (MCD) enabling evaluation of management questions and recommendations. We describe the scope of clinical inquiries and responses specific to linezolid use for MDR-TB in the US. RESEARCH QUESTION: What are the major themes of provider and patient challenges regarding the use of linezolid for the treatment of MDR-TB in the US? METHODS: We queried MCD consults categorized as "MDR/XDR-TB" from 1/1/2013 to 12/31/2018. Only linezolid-specific consultations were included; incomplete and duplicate entries were excluded as were those citing linezolid historically or theoretically. Subgroup characteristics were assessed (e.g., Center, year, provider type). A descriptive coding scheme was developed through inductive thematic analysis. RESULTS: In 2013-2018 of the 1889 consults regarding MDR/XDR-TB, 934 MDR-TB consults referenced linezolid; 137 met inclusion criteria, representing between 4 and 10% of MDR-TB consults annually. Four main themes emerged: adverse effects (71.5%); concerns about linezolid use due to co-morbidities or concurrent medication use (15.3%); dosing adjustments (8.8%); and monitoring and maintenance logistics (4.4%). INTERPRETATIONS: Linezolid consults consistently exceeded 4% of all consults annually over the 6-year period, suggesting a need for access to expert opinion for providers using linezolid to manage MDR-TB. While only a snapshot of MDR-TB in the US, this evaluation summarizes major provider concerns regarding particular adverse effects, and highlights a need for evidence-based guidance regarding linezolid dosing and toxicity management. |
A model for bringing TB expertise to HIV providers: Medical consultations to the CDC-funded Regional Tuberculosis Training and Medical Consultation Centers, 2013-2017
Fernando R , McDowell AC , Bhavaraju R , Fraimow H , Wilson JW , Armitige L , Haley C , Goswami ND . PLoS One 2020 15 (8) e0236933 BACKGROUND: Persons living with human immunodeficiency virus (HIV) are at a greater risk of developing tuberculosis (TB) compared to people without HIV and of developing complications due to the complexity of TB/HIV coinfection management. METHODS: During 2013-2017, the Centers for Disease Control and Prevention (CDC) funded 5 TB Regional Training and Medical Consultation Centers (RTMCCs) (now known as TB Centers of Excellence or COEs) to provide medical consultation to providers for TB disease and latent TB infection (LTBI), with data entered into a Medical Consultation Database (MCD). Descriptive analyses of TB/HIV-related consultations were conducted using SAS® software, version [9.4] to determine the distribution of year of consultation, medical setting and provider type, frequency of consultations regarding a pediatric (<18 years) patient, and to categorize key concepts and themes arising within consultation queries and medical consultant responses. RESULTS: Of 14,586 consultations captured by the MCD in 2013-2017, 544 (4%) were categorized as TB/HIV-related, with 100 (18%) received in 2013, 129 (24%) in 2014, 104 (19%) in 2015, 117 (22%) in 2016, and 94 (17%) in 2017. Most TB/HIV consultations came from nurses (54%) or physicians (43%) and from local (65%) or state health departments (10%). Only 17 (3%) of HIV-related consultations involved pediatric cases. Off the 544 TB/HIV consultations, 347 (64%) concerned the appropriate treatment regimen for TB/HIV or LTBI/HIV for a patient on or not on antiretroviral therapy (ART). CONCLUSIONS: The data support a clear and ongoing gap in areas of specialized HIV knowledge by TB experts that could be supplemented with proactive educational outreach. The specific categories of TB/HIV inquiries captured by this analysis are strategically informing future targeted training and educational activities planned by the CDC TB Centers of Excellence, as well as guiding HIV educational efforts at regional and national TB meetings. |
Impact of targeted local interventions on tuberculosis awareness and screening among persons experiencing homelessness during a large tuberculosis outbreak in Atlanta, Georgia, 2015-2016
Kerr EM , Vonnahme LA , Goswami ND . Public Health Rep 2020 135 90s-99s OBJECTIVES: Tuberculosis (TB) outbreaks disproportionately affect persons experiencing homelessness (PEH) in the United States. During 2014-2016, a resurgent TB outbreak occurred among PEH in Atlanta, Georgia. To control the outbreak, citywide policies and educational interventions were implemented in January 2015. Policy changes standardized and enforced TB screening requirements for PEH in homeless shelters. Educational campaigns informed PEH of the outbreak and encouraged TB screening. We evaluated factors associated with, and the effect policy changes and educational interventions had on, TB screening and awareness among PEH in Atlanta. METHODS: Questions related to TB screening and awareness of the outbreak were added to an annual US Department of Housing and Urban Development survey of PEH in Atlanta in 2015 (n = 296 respondents) and 2016 (n = 1325 respondents). We analyzed the 2016 survey data to determine characteristics associated with outcomes. RESULTS: From 2015 to 2016, reported TB screening increased from 81% to 86%, and awareness of the TB outbreak increased from 68% to 75%. In 2016, sheltered PEH were significantly more likely than unsheltered PEH to report being evaluated for TB in the previous 6 months (prevalence odds ratio [pOR] = 3.18; 95% confidence interval [CI], 2.28-4.47) and to report being aware of the TB outbreak (pOR = 4.00; 95% CI, 2.89-5.55). CONCLUSIONS: Implementation of required TB screening and educational interventions may reduce the incidence and severity of TB outbreaks among PEH in other communities. Furthermore, the annual survey of PEH offers an opportunity to collect data to better inform practices and policies. |
Multidrug-resistant tuberculosis care in the United States
Gobaud AN , Haley CA , Wilson JW , Bhavaraju R , Lardizabal A , Seaworth BJ , Goswami ND . Int J Tuberc Lung Dis 2020 24 (4) 409-413 BACKGROUND: To examine the utilization of the Tuberculosis (TB) Centers of Excellence (COE) medical consultation service and evaluate how these services were being employed for patients in relation to multidrug-resistant TB (MDR-TB).METHODS: Medical consults are documented in a secure database. The database was queried for MDR-TB consultations over the period 1 January 2013-31 December 2017. All were analyzed to assess provider type, center, setting, year of call, and type of patient (pediatric vs. adult). A subgroup was randomly selected for thematic analysis.RESULTS: The centers received 1560 MDR-TB consultation requests over this period. Providers requesting consults were primarily physicians (55%). The majority of requests were from public health departments (64%) and for adult patients (80%). Four major topic areas emerged: 1) initial management of MDR-TB, 2) MDR-TB longitudinal treatment and complications, 3) management of persons exposed to MDR-TB, and 4) MDR-TB treatment completion.CONCLUSIONS: Analysis of these consultations provides insight into the type of expert advice about MDR-TB that was provided. These findings highlight topics where increased medical training and education may help to improve MDR-TB-related practices. |
Tuberculosis in the United States: Medical consultation services provided by 5 Tuberculosis Regional Training and Medical Consultation Centers, 2013-2017
Goswami ND , Mase S , Griffith D , Bhavaraju R , Lardizabal A , Lauzardo M , Chen L , Wilson J , Chappelle C , Haley CA . Open Forum Infect Dis 2019 6 (6) ofz167 With only 9105 new US tuberculosis (TB) cases reported in 2017, expert consultation is essential for TB care. Data were captured 2013-2017 from consultations by 5 CDC-funded centers, now the TB Centers of Excellence (COEs). 14 586 consultations were provided to TB providers, most related to TB disease and treatment regimens. |
Notes from the Field: Meningeal and pulmonary tuberculosis on a commercial fishing vessel - Hawaii, 2017
Imada EK , Roberson EK , Goswami ND , Brostrom RJ , Moser K , Tardivel K . MMWR Morb Mortal Wkly Rep 2019 68 (24) 554-555 In December 2016, U.S. Customs and Border Protection notified the CDC Honolulu Quarantine Station of a crewman on a commercial fishing vessel who was hospitalized with suspected tuberculosis (TB); the crewman, in his mid-30s, was unconsciousness, intubated, and dependent upon mechanical ventilation to maintain his respiratory status. He was a native of a high TB-burden country (one with TB incidence exceeding 10 cases per 100,000 population per year)* in the Pacific region. Nine days earlier, he had been hospitalized in Hawaii following a 1-month history of headache, fever, night sweats, chills, fatigue, weight loss, breathing difficulties, and cough and recent onset of abdominal pain, vomiting, dizziness, and blurred vision. Brain computerized tomography (CT) and magnetic resonance imaging scans showed lesions in the left basal ganglia and left temporal lobe; chest CT showed multiple bilateral lung opacities with central cavitation. Pathology results from a lung biopsy demonstrated acid-fast bacilli with molecular and culture tests positive for Mycobacterium tuberculosis complex, susceptible to all first-line drugs. Cerebrospinal fluid demonstrated low glucose (23 mg/dL), elevated protein (247 mg/dL), and elevated white blood cell count (298 cells/uL) with a relative lymphocytic predominance (50%), consistent with TB meningitis. Testing for human immunodeficiency virus infection was negative, and the patient had no medical comorbidities. The Hawaii Department of Health (Hawaii DOH) was contacted to assist with the investigation. |
Tuberculosis screening, testing, and treatment of U.S. health care personnel: Recommendations from the National Tuberculosis Controllers Association and CDC, 2019
Sosa LE , Njie GJ , Lobato MN , Bamrah Morris S , Buchta W , Casey ML , Goswami ND , Gruden M , Hurst BJ , Khan AR , Kuhar DT , Lewinsohn DM , Mathew TA , Mazurek GH , Reves R , Paulos L , Thanassi W , Will L , Belknap R . MMWR Morb Mortal Wkly Rep 2019 68 (19) 439-443 The 2005 CDC guidelines for preventing Mycobacterium tuberculosis transmission in health care settings include recommendations for baseline tuberculosis (TB) screening of all U.S. health care personnel and annual testing for health care personnel working in medium-risk settings or settings with potential for ongoing transmission (1). Using evidence from a systematic review conducted by a National Tuberculosis Controllers Association (NTCA)-CDC work group, and following methods adapted from the Guide to Community Preventive Services (2,3), the 2005 CDC recommendations for testing U.S. health care personnel have been updated and now include 1) TB screening with an individual risk assessment and symptom evaluation at baseline (preplacement); 2) TB testing with an interferon-gamma release assay (IGRA) or a tuberculin skin test (TST) for persons without documented prior TB disease or latent TB infection (LTBI); 3) no routine serial TB testing at any interval after baseline in the absence of a known exposure or ongoing transmission; 4) encouragement of treatment for all health care personnel with untreated LTBI, unless treatment is contraindicated; 5) annual symptom screening for health care personnel with untreated LTBI; and 6) annual TB education of all health care personnel. |
Response to isoniazid-resistant tuberculosis in homeless shelters, Georgia, USA, 2015-2017
Holland DP , Alexander S , Onwubiko U , Goswami ND , Yamin A , Mohamed O , Sales RM , Grant G , Talboy P , Ray S , Toomey KE . Emerg Infect Dis 2019 25 (3) 593-595 In 2008, an outbreak of isoniazid-resistant tuberculosis was identified among residents of homeless shelters in Atlanta, Georgia, USA. When initial control efforts involving standard targeted testing failed, a comprehensive approach that involved all providers of services for the homeless successfully interrupted the outbreak. |
Notes from the field: Acquisition of delamanid under a compassionate use program for extensively drug-resistant tuberculosis - United States, 2017
Lardizabal AA , Khan AN , Bamrah Morris S , Goswami ND . MMWR Morb Mortal Wkly Rep 2018 67 (35) 996-997 On April 10, 2017, a middle-aged man from Eastern Europe was evaluated at a hospital with cough, chest pain, weakness, and weight loss. A sputum sample was smear-positive for acid-fast bacilli (AFB), and chest radiograph and chest computerized tomography scan showed bilateral pulmonary, cavitary disease with vertebral involvement. He was given standard first-line therapy (HRZE): isoniazid, rifampin, pyrazinamide, and ethambutol. Among three of the patient’s family members evaluated as part of the contact investigation, his wife tested positive for tuberculosis (TB) infection via QuantiFERON-TB Gold In-Tube test and was treated for latent TB infection with 4 months of rifampin.* |
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