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BACKGROUND:Treatment of melioidosis comprises intravenous drugs for at least 10 days, followed by oral trimethoprim-sulfamethoxazole (TMP-SMX) for 12 to 20 weeks. Twelve weeks of oral TMP-SMX is recommended in Australia, and 20 weeks in Thailand. METHODS:For this open-label, pragmatic, multicenter, non-inferiority, 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 (12-week regimen) or continue treatment for another eight weeks (20-week regimen). The primary endpoint was culture-confirmed recurrent melioidosis within one year after enrollment. The non-inferiority margin was a hazard ratio (HR) of 2.0. The secondary composite endpoint combining overall recurrent melioidosis and mortality was assessed post-hoc. RESULTS:658 patients were enrolled: 322 to the 12-week regimen and 336 to the 20-week regimen. Five patients (2%) in the 12-week regimen and 2 patients (1%) in the 20-week regimen developed culture-confirmed recurrent melioidosis (HR 2.66; 95% confidence interval [CI] 0.52-13.69). The criterion for non-inferiority of primary event was not met (one-sided P=.37). However, all-cause mortality was significantly lower in the 12-week regimen group than in the 20-week regimen group (1 [0.3%] vs. 11 [3%]; HR 0.10; 95% CI 0.01-0.74). The criterion for non-inferiority of the secondary composite endpoint combining overall recurrent melioidosis and mortality was met (one-sided P=.022). CONCLUSIONS:Based on the lower total mortality and non-inferiority of the secondary composite endpoint observed, we recommend the 12-week regimen of TMP-SMX for oral eradication treatment of melioidosis.

Original publication

DOI

10.1093/cid/ciaa1084

Type

Journal article

Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Publication Date

29/07/2020

Addresses

Faculty of Medicine, Khon Kaen University.