Efficacy, Safety, and PK of Ascending Dosages of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis (StrongMoxi)
Strongyloides Stercoralis Infection
About this trial
This is an interventional treatment trial for Strongyloides Stercoralis Infection
Eligibility Criteria
Inclusion Criteria:
- Adults (≥ 18 years) infected with S. stercoralis
- Absence of major systemic illnesses
- Written informed consent signed by individual
Exclusion Criteria:
- Any abnormal medical conditions or chronic disease
- Negative diagnostic result for S. stercoralis
- No written informed consent by individual.
- Pregnant and lactating women.
- Recent use of anthelmintic drug (within past 4 weeks), attending other clinical trials during the study
- Known allergy to study medications (i.e. moxidectin, ivermectin)
- Currently taking medications with known interaction (i.e. for warfarin)
Sites / Locations
- National Centre for Parasitology, Entomology and Malaria Control
- National Institute of Public Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Active Comparator
Placebo Comparator
Phase 2a - Arm A
Phase 2a - Arm B
Phase 2a - Arm C
Phase 2a - Arm D
Phase 2a - Arm E
Phase 2a - Arm F
Phase 2a - Arm G
Phase 2b - Arm A
Phase 2b - Arm B
Phase 2b - Arm P
2 mg Moxidectin at day 0 administered orally
4 mg Moxidectin at day 0 administered orally
6 mg Moxidectin at day 0 administered orally
8 mg Moxidectin at day 0 administered orally
10 mg Moxidectin at day 0 administered orally
12 mg Moxidectin at day 0 administered orally
matching Placebo tablet(s) at day 0 administered orally
the recommended dose moxidectin (i.e. the most promising dosage identified in trial A; between 2-12 mg) at day 0 administered orally
200 µg/kg ivermectin at day 0 administered orally
matching Placebo tablet(s) at day 0 administered orally