Efficacy and Safety of MOX/ALB Co-administration

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole versus albendazole monotherapy (standard of care) against whipworm (T. trichiura) infections in adolescents and adults (12-60 years) in Côte d'Ivoire. One arm of patients will be treated with albendazole-ivermectin.

As measure of efficacy of the treatment the cure rate (percentage of egg-positive subjects at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.

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

Details

• Lead Sponsor: Jennifer Keiser
• Collaborator: Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
• Treatments: Albendazole; Ivermectin; Milbemycin; Moxidectin

Criteria

Inclusion Criteria:

• Aged between 12 and 60 years

• Written informed consent signed by either parents/caregivers for underage adolescents (aged 12-17 years) or by the participant him/herself (18-60 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 at follow-up assessment 14-21 days 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:

• 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

• Known or suspected infection with Loa loa

• History of acute or severe chronic disease

• Abnormal liver function assessed by multiple biochemical blood-based analyses

• 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 3 months

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

• Taking medication with known contraindication to or interaction with study drugs