Efficacy and Safety of MOX/ALB Co-administration
Trichuriasis, Ascariasis, Hookworm Infections
About this trial
This is an interventional treatment trial for Trichuriasis focused on measuring Albendazole, Moxidectin, Ivermectin, Anthelmintics, T. trichiura, A. lumbricoides, Hookworm, Whipworm, Soil-transmitted helminths
Eligibility 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
Sites / Locations
- Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Experimental
Arm A: moxidectin and albendazole
Arm B: albendazole
Arm C: ivermectin and albendazole
Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0