Auranofin for Giardia Protozoa (NCT02736968) | Clinical Trial Compass
CompletedPhase 2
Auranofin for Giardia Protozoa
Bangladesh93 participantsStarted 2016-11-06
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Provide written informed consent prior to initiation of any study procedures.
✓. Able to understand and comply with planned study procedures and be available for all study visits.
✓. Male or non-pregnant non-lactating females 18-65 years of age, inclusive. Females of reproductive potential currently using effective contraceptive methods are eligible.
✓. Amebiasis or giardiasis identified by rapid Enzyme Immunoassay (EIA) and positive antigen detection EIA of stool
✓. Has diarrhea (defined as three or more loose stools) in the past 24 hrs, but is assessed to be clinically stable and in otherwise good health
Exclusion criteria
✕. Vital signs (oral temperature, pulse, and blood pressure) are all within normal protocol-defined ranges.
✕. Laboratory tests (blood urea nitrogen, creatinine, aspartate transaminase (AST), alanine transaminase (ALT), white blood cells, platelets, and hemoglobin) are all within protocol-defined ranges. Subjects will be eligible for enrollment with the following laboratory values: blood urea nitrogen less than or equal to 30 mg/dL, creatinine less than or equal to 133 umol/L, AST or ALT less than or equal to 70.0 U/L, white cell count between 3.5 and 13.0 inclusive (10\^9/L), platelets between 131 and 550 (10\^9/L), hemoglobin between 11.0 and 18.0 gm/dL inclusive.
What they're measuring
1
Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia and Resolution of Diarrhea (Less Than 3 Loose Stools/24 Hours)
Timeframe: Day 5
2
Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia at Enrollment With Parasitological Response (no Detection of Cysts or Trophozoites on Microscopic Exam or Negative Antigen Test)
Timeframe: Day 5
Trial details
NCT IDNCT02736968
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. Urinalysis with no greater than trace protein. If a high protein is confirmed to be due to menstruation, it should be repeated.
✕. Women of reproductive potential must have a negative urine pregnancy test within 72 hours of starting study medications.
✕0. Female subjects participating in sexual activity that could lead to pregnancy must be using and continue to use highly effective contraception for a total of 4 months after enrollment.
✕. Known intolerance of auranofin or gold compounds.
✕. Pregnant or breastfeeding women or women of reproductive potential not using effective contraception or who plan to become pregnant or breastfeed at any given time during the study or within 3 months of study completion.