Phase 3
N=255
Efficacy and Safety of MOX/ALB Co-administration
Trichuriasis · Ascariasis · Hookworm Infections
Bottom Line
View on ClinicalTrials.gov: NCT04726969 ↗Enrolled (actual)
255
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura — 15.3; 13.4 percentage of participants (%)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Moxidectin 2 mg Oral Tablet (Drug); Albendazole 400 mg Oral Tablet (Drug); Ivermectin 3 mg Oral Tablet (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Jennifer Keiser
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura |
15.3; 13.4 | — |
| SECONDARY Egg Reduction Rate (ERR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura |
67.0; 60.2 | — |
| SECONDARY Cure Rate (CR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura |
13.4; 22.5 | — |
| SECONDARY Egg Reduction Rate (ERR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura |
60.2; 81.5 | — |
| SECONDARY Cure Rates (CRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants |
95.5; 95.5; 100 | — |
| SECONDARY Egg Reduction Rates (ERRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants |
100; 100; 100 | — |
| SECONDARY Cure Rates (CRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants |
100; 37.5; 20.0 | — |
| SECONDARY Egg Reduction Rates (ERRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants |
100; 95.7; 90.7 | — |
| SECONDARY Number of Participants Reporting Adverse Events (AEs) |
1; 5; 7; 4; 6; 8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04726969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.