Clinical Trial: Auranofin Trial for GI Protozoa

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

Detailed 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. Secondary objectives for E. histolytica infections 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 Days 3 and 5, 2) to compare the rate of decrease of trophozoites/cyst load by qPCR in stools by Days 3, 5, and 7, 3) to compare the proportion of subjects with negative stool antigen tests by days 3, 5, 7, and 14, 4) to compare the proportion of subjects with sustained cure (no detection of cysts or trophozoites by microscopic exam or negative antigen detection) at 14 and 28 days, and 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. Secondary objectives for Giardia infections are 1) 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 3, 2) to compare the rate of decrease of trophozoites/cyst load by qPCR in stools by Days 3 and 5, 3) to compare
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • Proportion of subjects with parasitological response of E. histolytica (no detection of cysts or trophozoites of E. histolytica on microscopic exam or negative antigen detection). [ Time Frame: Day 7 ]
  • Proportion of subjects with parasitological response of Giardia (no detection of cysts or trophozoites on microscopic exam or negative antigen detection) [ Time Frame: Day 5 ]


Original Primary Outcome:

  • Proportion of subjects with parasitological response of Giardia (no detection of cysts or trophozoites on microscopic exam or negative antigen detection) [ Time Frame: Day 5 ]
  • Proportion of subjects with parasitological response of E. histolytica (no detection of cysts or trophozoites of E. histolytica on microscopic exam or negative antigen detection). [ Time Frame: Day 7 ]


Current Secondary Outcome:

  • Proportion of subjects with negative E. histolytica stool antigen test [ Time Frame: Day 3, 5, 7, and 14 ]
  • Proportion of subjects with parasitological response (no detection of cysts or trophozoites on microscopic exam or negative antigen detection) to E. histolytica. [ Time Frame: Day 3 and 7 ]
  • Proportion of subjects with parasitological response to Giardia (no detection of cysts or trophozoites on microscopic exam or negative antigen detection) [ Time Frame: Day 3 ]
  • Proportion of subjects with relapse (same strain) or re-infection (new strain) with E. histolytica positive stools by genotyping the initial vs. subsequent strain [ Time Frame: Day 14 and 28 ]
  • Proportion of subjects with relapse (same strain) or re-infection (new strain) with Giardia positive stools by genotyping the initial vs. subsequent strain [ Time Frame: Day 14 and 28 ]
  • Proportion of subjects with sustained E. histolytica cure (no detection of cysts or trophozoites by microscopic exam or negative antigen detection) [ Time Frame: Day 14 and 28 ]
  • Proportion of subjects with sustained Giardia cure (no detection of cysts or trophozoites by microscopic exam or negative antigen detection) [ Time Frame: Day 14 and 28 ]
  • Rate of decrease of E. histolytica trophozoite/cyst load by qPCR in stools by Days 3, 5, and 7 [ Time Frame: Day 3, 5, and 7 ]
  • Rate of decrease of Giardia trophozoite/cyst load by qPCR in stools [ Time Frame: Day 3 and 5 ]


Original Secondary Outcome:

  • Proportion of subjects with sustained E. histolytica cure (no detection of cysts or trophozoites by microscopic exam or negative antigen detection) [ Time Frame: Day 14 and 28 ]
  • Proportion of subjects with relapse (same strain) or re-infection (new strain) with E. histolytica positive stools by genotyping the initial vs. subsequent strain [ Time Frame: Day 14 and 28 ]
  • Proportion of subjects with parasitological response to Giardia (no detection of cysts or trophozoites on microscopic exam or negative antigen detection) [ Time Frame: Day 3 ]
  • Rate of decrease of Giardia trophozoite/cyst load by qPCR in stools [ Time Frame: Day 3 and 5 ]
  • Proportion of subjects with sustained Giardia cure (no detection of cysts or trophozoites by microscopic exam or negative antigen detection) [ Time Frame: Day 14 and 28 ]
  • Proportion of subjects with negative E. histolytica stool antigen test [ Time Frame: Day 3, 5, 7, and 14 ]
  • Proportion of subjects with parasitological response (no detection of cysts or trophozoites on microscopic exam or negative antigen detection) to E. histolytica. [ Time Frame: Day 3 and 7 ]
  • Rate of decrease of E. histolytica trophozoite/cyst load by qPCR in stools by Days 3, 5, and 7 [ Time Frame: Day 3, 5, and 7 ]
  • Proportion of subjects with relapse (same strain) or re-infection (new strain) with Giardia positive stools by genotyping the initial vs. subsequent strain [ Time Frame: Day 14 and 28 ]


Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: April 7, 2016
Date Started: August 19, 2016
Date Completion: May 31, 2020
Last Updated: May 4, 2017
Last Verified: January 4, 2017