Auranofin for Giardia Protozoa
Condition: Amoebic Dysentery; Giardiasis
MeSH terms: Giardiasis; Dysentery, Amebic; Dysentery
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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. Secondary objectives for E. histolytica infections are: 1) to
      compare the proportion of subjects with stools positive by rapid EIA and positive antigen
      detection EIA for E. histolytica and trophozoites on smear at enrollment with parasitological
      response (no detection of trophozoites of E. histolytica on microscopic exam) by Day 7; 2) to
      compare the proportion of subjects with stools positive rapid EIA and positive antigen
      detection EIA for E. histolytica and trophozoites on smear at enrollment with parasitological
      response (no detection of trophozoites on microscopic exam or negative antigen detection) by
      Days 3 and 5; 3) to compare the rate of decrease of trophozoites/cyst load by Quantitative
      Polymerase Chain Reaction (qPCR) in stools by Days 3, 5, and 7; 4) to compare the proportion
      of subjects with negative stool antigen tests by days 3, 5, 7, and 14; 5) to compare the
      proportion of subjects with sustained cure (no detection of trophozoites by microscopic exam)
      at 14 and 28 days; 6) to compare the proportion of subjects with relapse (same strain) or
      re-infection (new strain) with positive stools at 14 and 28 days by genotyping the initial
      vs. subsequent strain; 7) to compare the time to resolution of diarrhea (less than 3 loose
      stools/24 hours). Secondary objectives for Giardia infections are: 1) to compare the
      proportion of subjects with parasitological response (no detection of trophozoites on
      microscopic exam ) on Day 3, and 5; 2) to compare the rate of decrease of trophozoites/cyst
      load by qPCR in stools by Days 3 and 5; 3) to compare the proportion of subjects with
      negative stool antigens by days 3 and 5; 4) to compare the proportion of subjects with
      sustained cure (no detection of trophozoites by microscopic exam) at 14 and 28 days; 5) to
      compare the proportion of subjects with relapse (same strain) or re-infection (new strain)
      with positive stools at 14 and 28 days by genotyping the initial vs. subsequent strain; 6) to
      compare the time to resolution of diarrhea (less than 3 loose stools/24 hours).
    

Intervention name(s): Auranofin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Auranofin is a gold-containing chemical salt available as 3mg capsules; Placebo
Intervention MeSH terms: Auranofin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amebiasis; Auranofin; GI Protozoa; Giardiasis; Placebo-Controlled; Reprofiled Drug; Single-Blind