Efficacy and Safety of IVM/ALB Co-administration

• Status: Completed
• Trial end date: 2020-07-15
• Target enrollment: 0
• Participant gender: All

Summary

This study is a double-blind randomized clinical trial conducted with two settings in Africa and one in Asia, namely Côte d'Ivoire, Pemba (Zanzibar, Tanzania) and Lao PDR. This study aims at providing evidence on the efficacy and safety of co-administered albendazole and ivermectin versus albendazole monotherapy (standard of care) against whipworm (T. trichiura) infections in children and adults (6-60 years).

The efficacy of the treatment and potential extended effects on follow-up prevalence will be determined 14-21 days, 6 months and 12 months post-treatment by collecting another two stool samples. The cure rate will be calculated as the percentage of egg-positive subjects at baseline who become egg-negative after treatment.

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

Details

• Lead Sponsor: Jennifer Keiser
• Collaborators: Centre Suisse de Recherches Scientifiques en Cote d'Ivoire; Côte d'Ivoire: Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS); Lao PDR: National Institute of Public Health (NIOPH); Lao Tropical and Public Health Institute; Pemba, Tanzania: Public Health Laboratory Ivo de Carneri; Public Health Laboratory of Pemba, Tanzania
• Treatments: Albendazole; Ivermectin

Criteria

Inclusion Criteria:

1. Written informed consent signed by either the participant him/herself (≥21 years of age) or by parents and/or caregivers for children/adolescents; and written assent by child/adolescent (aged 6-20 years).

2. Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and on three follow-up assessments (approximately 3 weeks, 6 months, and 12 months later).

3. Aged ≥6 to <= 60 years for parallel group trial and ≥6 to <=12 years for DF study.

4. At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura and infection intensities of at least 100 EPG.

Exclusion Criteria:

1. No written informed consent by individual/parents and/or caregiver.

2. Presence of major systemic illnesses, e.g. severe anemia (below 80 g/l Hb according to WHO [28]), clinical malaria as assessed by a medical doctor (positive Plasmodium RDT and ≥38 °C ear temperature), upon initial clinical assessment.

3. History of acute or severe chronic disease (e.g. cancer, diabetes, chronic heart, liver or renal disease).

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

5. Attending other clinical trials during the study.

6. Negative or low egg count (less than 100 EPG or less than 2 out of 4 slides positive) diagnostic result for T. trichiura eggs in the stool.

7. Known allergy to study medications (i.e. albendazole and ivermectin).

8. Pregnancy or lactating in the 1st week after birth (according to WHO guidelines within LF control programs [29]).

9. Currently taking medication with known interaction (e.g. for albendazole: cimetidine, praziquantel and dexamethasone; for ivermectin: warfarin).