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.
| Autor: | Anunnatsiri, Siriluck, Chaowagul, Wipada, Teparrukkul, Prapit, Chetchotisakd, Ploenchan, Tanwisaid, Kittisak, Khemla, Supphachoke, Narenpitak, Surapong, Pattarapongsin, Moragot, Kongsawasd, Wirod, Pisuttimarn, Pornrith, Thipmontree, Wilawan, Mootsikapun, Piroon, Chaisuksant, Seksan, Chierakul, Wirongrong, Day, Nicholas P J, Limmathurotsakul, Direk |
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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 |
| Zdroj: | Clinical Infectious Diseases; Dec2021, Vol. 73 Issue 11, pe3627-e3633, 7p |
| Abstrakt: | 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] |
| Databáze: | Complementary Index |
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