Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this randomized controlled trial is to provide evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to co-administered ivermectin and albendazole, and to assess the efficacy of the drug combinations compared to monotherapies in adolescents aged 12-19 years against infection with T. trichiura.

The efficacy of the different treatments will be determined 14-21 days, 5-6 weeks and 3 months post-treatment. Two fecal samples will be collected at each time-point assessment. The geometric mean based egg reduction rate (ERR) of T. trichiura egg counts will be assessed by Kato-Katz microscopy pre-treatment and 14-21 days post-treatment.

This trial will be conducted as a school-based study on Pemba Island (Zanzibar, Tanzania).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jennifer Keiser
• Collaborators: Public Health Laboratory Ivo de Carneri; Public Health Laboratory Ivo de Carneri, Chake Chake, Pemba, Zanzibar, Tanzania
• Treatments: Albendazole; Ivermectin; Milbemycin; Moxidectin

Criteria

Inclusion Criteria:

• Aged between 12 and 19 years.

• Written informed consent signed by either parents/caregivers for underage adolescents (aged 12-17 years) or by the participant him/herself (18-19 years of age); and written assent by underage participant.

• Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and on three follow-up assessments (14-21 days, 5-6 weeks and 3 months after treatment).

• Willing to be examined by a study physician prior to treatment.

• At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura and infection intensities of at least 48 EPG.

Exclusion Criteria:

• No written informed consent by individual or caregiver and/or no written assent by minors

• Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38°C, severe anemia (below 80g/l Hb according to WHO) upon initial clinical assessment.

• History of acute or severe chronic disease.

• Recent use of anthelmintic drug (within past 4 weeks).

• Attending other clinical trials during the study.

• Pregnancy, lactating, and/or planning to become pregnant within the next 6 months.

• Known allergy to study medications (i.e. albendazole, ivermectin or moxidectin).

• Taking medication with known interaction on study drugs.