Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase IIa Randomized, Single-blinded, Placebo-controlled Clinical Trial of the Reprofiled Drug Auranofin for GI Protozoa
Brief Summary: This is a phase IIa, randomized, placebo-controlled, single-blinded superiority treatment study to compare placebo to once daily doses of 6mg auranofin for adults with asymptomatic amebiasis or giardiasis. A sample size of 68 subjects enrolled with amebiasis (34 per arm) and 68 with giardiasis (34 per arm); Power based on 60 subjects with amebiasis and 60 with giardiasis completing the study. Primary objectives are 1) to compare the proportion of subjects with parasitological response (no detection of cysts or trophozoites of E. histolytica on microscopic exam or negative antigen detection) by Day 7 for E. histolytica infections and 2)to compare the proportion of subjects with parasitological response (no detection of cysts or trophozoites of G. lamblia on microscopic exam or negative antigen detection) by Day 5 for Giardia infections. The length of this study is set for 3.5 years; subject participation is 7 days treatment (amebiasis) and 5 days (giardiasis) with follow-up until day 28