Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura
MOXIDOSE
1 other identifier
interventional
286
1 country
1
Brief Summary
The study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura. The study will take place on Pemba Island, Tanzania.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedStudy Start
First participant enrolled
July 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2018
CompletedAugust 14, 2018
August 1, 2018
1 month
March 1, 2018
August 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Cure rate against Trichuris trichiura
Conversion from being Trichuris trichiura-egg positive pre-treatment to egg negative post-treatment. Since this might be influenced by infection intensity, treatment groups will be equally balanced in terms of infection intensity by 2 levels of baseline infection intensity (light infections and moderate/heavy infections).
6 weeks
Secondary Outcomes (6)
Egg Reduction Rate of the different drug regimens against Trichuris trichiura
6 weeks
Cure rate of the different drug regimens against Ascaris lumbricoides
6 weeks
Egg Reduction Rate of Ascaris lumbricoides
6 weeks
Cure rate against hookworm
6 weeks
Egg Reduction Rate of hookworm
6 weeks
- +1 more secondary outcomes
Study Arms (7)
Moxidectin 8 mg
EXPERIMENTALA single tablet of 8 mg of moxidectin
Moxidectin 8 mg + Albendazole
EXPERIMENTALA single tablet of 8 mg of moxidectin plus a single tablet of albendazole (400 mg)
Moxidectin 16 mg
EXPERIMENTALTwo tablets of 8 mg of moxidectin ( = 16 mg)
Moxidectin 16 mg + Albendazole
EXPERIMENTALTwo tablets of 8 mg of moxidectin ( = 16 mg) plus a single tablet of albendazole (400 mg)
Moxidectin 24 mg
EXPERIMENTALThree tablets of 8 mg of moxidectin ( = 24 mg)
Moxidectin 24 mg + Albendazole
EXPERIMENTALThree tablets of 8 mg of moxidectin ( = 24 mg) plus a single tablet of albendazole (400 mg)
Placebo
PLACEBO COMPARATORA single tablet of placebo
Interventions
Participants will receive the tablet with clean water and a package of biscuits.
Participants will receive the tablets with clean water and a package of biscuits.
Participants will receive the tablets with clean water and a package of biscuits.
Participants will receive the tablets with clean water and a package of biscuits.
Participants will receive the tablets with clean water and a package of biscuits.
Participants will receive the tablets with clean water and a package of biscuits.
Eligibility Criteria
You may qualify if:
- Male and female subjects aged 16 to 18 years, inclusive
- Written informed consent/assent signed from parent/guardian
- Positive for T. trichiura by at least two slides of the quadruple Kato-Katz thick smears and infection intensities of at least 100 eggs per gram of stool (EPG)
- Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).
You may not qualify if:
- Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
- Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
- Prior treatment with anthelmintics (eg, diethylcarbamazine \[DEC\], suramin, ivermectin or albendazole) within 4 weeks before planned test article administration.
- Received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.
- Known or suspected allergy to moxidectin, ivermectin or albendazole or other compounds related to these classes of medication.
- Pregnant (urine testing) or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Public Health Laboratory Ivo de Carneri, P.O. Box 122
Chake Chake, Pemba, Tanzania
Related Publications (1)
Keller L, Palmeirim MS, Ame SM, Ali SM, Puchkov M, Huwyler J, Hattendorf J, Keiser J. Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris trichiura in Adolescents: A Randomized Controlled Trial. Clin Infect Dis. 2020 Mar 3;70(6):1193-1201. doi: 10.1093/cid/ciz326.
PMID: 31044235DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Participants will receive placebos. Outcome assessors and caregivers will not have access to the list of children allocated to each treatment arm.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 1, 2018
First Posted
April 18, 2018
Study Start
July 3, 2018
Primary Completion
August 11, 2018
Study Completion
August 11, 2018
Last Updated
August 14, 2018
Record last verified: 2018-08