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Comparison Between 12 Versus 20 Weeks of Trimethoprim-sulfamethoxazole as Oral Eradication Treatment for Melioidosis: An Open-label, Pragmatic, Multicenter, Non-inferiority, Randomized Controlled Trial.
- Source :
- Clinical Infectious Diseases; Dec2021, Vol. 73 Issue 11, pe3627-e3633, 7p
- Publication Year :
- 2021
-
Abstract
- Background Treatment of melioidosis comprises intravenous drugs for at least 10 days, followed by oral trimethoprim-sulfamethoxazole (TMP-SMX) for 12 to 20 weeks. Oral TMP-SMX is recommended for 12 weeks in Australia and 20 weeks in Thailand. Methods For this open-label, pragmatic, multicenter, noninferiority, randomized controlled trial, we enrolled patients with culture-confirmed melioidosis who had received oral eradication treatment for 12 weeks and had no clinical evidence of active melioidosis. We randomly assigned patients to stop treatment (12-week regimen) or continue treatment for another 8 weeks (20-week regimen). The primary end point was culture-confirmed recurrent melioidosis within 1 year after enrollment. The noninferiority margin was a hazard ratio (HR) of 2.0. The secondary composite end point, combining overall recurrent melioidosis and mortality, was assessed post hoc. Results We enrolled 658 patients: 322 to the 12-week regimen and 336 to the 20-week regimen. There were 5 patients (2%) in the 12-week regimen and 2 patients (1%) in the 20-week regimen who developed culture-confirmed recurrent melioidosis (HR, 2.66; 95% confidence interval [CI],.52–13.69). The criterion for noninferiority of the primary event was not met (1-sided P =.37). However, all-cause mortality was significantly lower in the 12-week regimen group than in the 20-week regimen group (1 [.3%] vs 11 [3%], respectively; HR, 0.10; 95% CI,.01–.74). The criterion for noninferiority of the secondary composite end point, combining overall recurrent melioidosis and mortality, was met (1-sided P =.022). Conclusions Based on the lower total mortality and noninferiority of the secondary composite end point observed, we recommend the 12-week regimen of TMP-SMX for oral eradication treatment of melioidosis. Clinical Trials Registration NCT01420341. [ABSTRACT FROM AUTHOR]
- Subjects :
- RESEARCH
STATISTICS
CAUSES of death
CO-trimoxazole
MELIOIDOSIS
CLINICAL trials
CONFIDENCE intervals
ORAL drug administration
DISEASE eradication
TREATMENT duration
MEDICAL cooperation
RANDOMIZED controlled trials
COMPARATIVE studies
DISEASE relapse
DESCRIPTIVE statistics
STATISTICAL sampling
DATA analysis
Subjects
Details
- Language :
- English
- ISSN :
- 10584838
- Volume :
- 73
- Issue :
- 11
- Database :
- Complementary Index
- Journal :
- Clinical Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 154040063
- Full Text :
- https://doi.org/10.1093/cid/ciaa1084