Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole

Phase 2 Completed 78 enrolled Hospital Universitari Vall d'Hebron Research Institute Hospital Vall d'Hebron · collab International Health Unit Metropolitana Nord. Santa Coloma. · collab Tropical Medicine and International Health Unit Drassanes. Barcelona · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi.

Timeline

Start: 2010-09
Primary completion: 2012-12
Completion: 2013-03

Outcome

Missed primary endpoint

paper However, significantly more patients in the posaconazole groups than in the benznidazole group had treatment failure during follow-up. PMID 24827034 ↗

paper 92% of the patients receiving low-dose posaconazole and 81% receiving high-dose posaconazole, as compared with 38% receiving benznidazole, tested positive PMID 24827034 ↗

Publications

Molina I, Gomez i Prat J, Salvador F, Trevino B, Sulleiro E, Serre N, Pou D, Roure S, Cabezos J, Valerio L, Blanco-Grau A, Sanchez-Montalva A, Vidal X, Pahissa A. Randomized trial of posaconazole and benznidazole for chronic Chagas' disease. N Engl J Med. 2014 May 15;370(20):1899-908. doi: 10.1056/NEJMoa1313122.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Benznidazole	Small molecule	150 mg	—
Subject	Posaconazole	Small molecule	100 mg	—
Subject	Posaconazole	Small molecule	400 mg	—