BACKGROUND: Severe malaria can be deadly and requires treatment with intravenous artesunate (IVAS). The Centers for Disease Control and Prevention provided IVAS starting April 1, 2019 for all patients with severe malaria in the United States. This study describes the safety and effectiveness of IVAS in these patients. METHODS: Patients meeting criteria for severe malaria April 2019-December 2020 who received IVAS were included. Demographic, clinical, laboratory, adverse event, and outcome information were collected. Clinical presentation, time to reach 1% and 0% parasitemia, adverse events, and death were described using proportions, medians, interquartile range (IQR), and tests of significance for differences in proportions. RESULTS: Of 280 patients included, the majority were male (61.4%), Black/African American (75.0%), with a median age of 35 years (IQR 15.8-53.9). Most had P. falciparum (83.6%) with median parasitemia of 8.0% (IQR 4.6-13.2). Of 170 patients with information, 159 (93.5%) reached ≤1% parasitemia by the third IVAS dose with a median time of 17.6 hours (IQR 10.8-28.8), and 0% parasitemia in a median of 37.2 hours (IQR: 27.2-55.2). Patients with parasite densities >10% and those requiring adjunct therapy had significantly higher parasite clearance times. Adverse events associated with IVAS were reported in 4.8% (n=13 of 271). Eight patients had post-artesunate delayed hemolysis that resolved. There were five (1.8%) deaths, all attributable to severe malaria. CONCLUSIONS: IVAS is a safe and effective drug for the treatment of severe malaria in the United States; timely administration can be lifesaving.

The use of culture independent diagnostic tests (CIDTs), such as stool antigen tests, as standalone tests for the detection of Campylobacter in stool is increasing. We conducted a prospective, multicenter study to evaluate the performance of stool antigen CIDTs compared to culture and PCR for Campylobacter detection. Between July and October, 2010, we tested 2,767 stool specimens from patients with gastrointestinal illness with the following methods: four types of Campylobacter selective media, four commercial stool antigen assays, and a commercial PCR assay. Illnesses from which specimens were positive by one or more culture media or at least one CIDT and PCR were designated as 'cases'. A total of 95 specimens (3.4 %) met the case definition. The sensitivity/specificity/positive predictive values of the stool antigen CIDTs ranged from 79.6%-87.6% in sensitivity, 95.9 - 99.5% specificity, and 41.3 - 84.3% positive predictive value. Culture alone detected 80/89 (89.9% sensitivity) C. jejuni/C. coli positive cases. Of the 209 non-cases that were positive by at least one CIDT, only one (0.48%) was positive by all four stool antigen tests, and 73% were positive by just one stool antigen test. The questionable relevance of unconfirmed positive stool antigen CIDT results was supported by the finding that non-cases were less likely than cases to have gastrointestinal symptoms. Thus, while convenient to use, the sensitivity, specificity and positive predictive value of Campylobacter stool antigen tests were highly variable. Given the relatively low incidence of Campylobacter disease and the generally poor diagnostic test characteristics, this study calls into question the use of commercially available stool antigen CIDT tests as standalone tests for direct detection of Campylobacter in stool.