Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration
Trichuriasis, Ascariasis, Hookworm Infections
About this trial
This is an interventional treatment trial for Trichuriasis focused on measuring T. trichiura, A. lumbricoides, Hookworm, Soil-transmitted Helminths, Albendazole, Ivermectin, Moxidectin, Intestinal parasites, Anthelmintics
Eligibility 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.
Sites / Locations
- Public Health Laboratory Ivo de Carneri
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Active Comparator
Active Comparator
Active Comparator
Active Comparator
A: moxidectin (8 mg) / albendazole (400 mg)
B: ivermectin (200 µg/kg) / albendazole (400 mg)
C: albendazole (400 mg)
D: ivermectin (200 µg/kg)
E: moxidectin (8 mg)
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0