This is a phase IIa, randomized, placebo-controlled, single-blinded superiority treatment
study in males and non-pregnant females, 18 to 65 years of age who are in good health. This
study is designed to compare placebo to once daily doses of 6mg auranofin for adults with
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.Eligible subjects will be randomly assigned to a treatment
group with auranofin (6 mg orally once daily for 5 days for giardiasis or 7 days for
amebiasis) compared to a placebo group receiving similar but not identical placebo capsules.
Projected duration of subject participation will be approximately 30 days of face to face
visits, including the pre-enrollment screening period of up to 4 days. It is anticipated that
it will take approximately 3.5 years to finish the study. Primary objectives are: 1) to
compare the proportion of subjects with stools positive by rapid Enzyme Immunoassay (EIA) and
positive antigen detection EIA for E. histolytica at enrollment with resolution of diarrhea
(less than 3 loose stools/24 hrs) by Day 7 for E. histolytica infections. 2) to compare the
proportion of subjects with stools positive by rapid EIA and positive antigen detection EIA
for Giardia at enrollment with resolution of diarrhea (less than 3 loose stools/24 hrs) by
Day 5 for Giardia infections.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)