Pilot Human Study of Tinidazole Efficacy For Radical Cure Of Plasmodium Vivax

Phase 2 Completed 20 enrolled Walter Reed Army Institute of Research (WRAIR)

RandomizedParallel-groupOpen-labelTreatment

Summary

Assess the efficacy of 2 grams of tinidazole given for 5 days with standard dose chloroquine to achieve radical cure of Plasmodium vivax within a 90 day follow-up period sufficient to justify an IND and formal phase II evaluation.

Timeline

Start: 2008-11
Primary completion: 2009-01
Completion: 2009-04

Outcome

Missed primary endpoint

paper Six of the first seven subjects treated with tinidazole relapsed prior to Day 63 (average Day 48.3 (range 42-56)). PMID 23718705 ↗

paper Tinidazole is ineffective in preventing relapse of P. vivax at the dose used. PMID 23718705 ↗

Publications

Macareo L, Lwin KM, Cheah PY, Yuentrakul P, Miller RS, Nosten F. Triangular test design to evaluate tinidazole in the prevention of Plasmodium vivax relapse. Malar J. 2013 May 29;12:173. doi: 10.1186/1475-2875-12-173.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Chloroquine	Small molecule	—	Oral
Subject	tinidazole	Small molecule	2 g	Oral