Clinical Trial: Study of the Efficacy of Oxfendazole Compared to Albendazole in the Treatment of Trichuris Trichiura Infection in Adults

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: An Open Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to Single Dose Albendazole in the Treatment of Trichuris Trichiura Infection in Adults

Brief Summary: The aim of this study is to provide data on the efficacy of oxfendazole against Trichuris trichiura at different doses in comparison to the standard single 400 mg dose of albendazole. In addition, the study will provide data on oxfendazole efficacy against other common nematodes encountered in man (Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenalis, Necator americanus).

Detailed Summary:

This is an open, comparative study in adult patients with proven intestinal infection with Trichuris trichiura. Patients meeting the study entry criteria will receive either 6mg/kg, or 30 mg/kg of oxfendazole as a single oral dose or 6 mg/kg orally for three days or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined 7, 14 and 21 days after treatment.

Two hundred clinically evaluable patients of either gender, 16 - 65 years of age, presenting with proven Trichuris trichiura infection, recruited from one centre, will be included in the study. there will be 15 patients in each treatment group. Duration of accrual will be determined in discussion with the clinical site in Iquitos, Peru.

Sponsor: Robert Gilman

Current Primary Outcome:

• Cure of Trichuris trichiura [ Time Frame: day 21 following treatment ]
  Cure of infection (Clinical Cure) shown by absence of Trichuris eggs in stool examinations at Day 21, using Kato Katz test.
• Reduction in Trichuis trichiura eggs (compared to pretreatment) [ Time Frame: day 21 following treatment ]
  Reduction (compared to baseline) of Trichuris eggs in stool examinations at 21, using Kato Katz test.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Cure of other intestinal helminths [ Time Frame: day 21 following treatment ]
  Absence of Ascaris, Necator eggs in stool using Kato Katz test
• Safety and tolerability of oxfendazole in the treatment of adult patients assessed by cumulative adverse events [ Time Frame: treatment through day 21 following treatment ]
  Cumulative adverse events following treatment up to Day 21

Original Secondary Outcome: Same as current

Information By: Johns Hopkins Bloomberg School of Public Health

Dates:
Date Received: December 14, 2015
Date Started: November 2017
Date Completion: February 2019
Last Updated: March 2, 2017
Last Verified: March 2017