Clinical trial NCT03501251: Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura
Official title: Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura in Adolescents: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trichuris Trichiura; Infection
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Public Health Laboratory Ivo de Carneri
First posted: 2018-04-18
Enrollment: 286
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects aged 16 to 18 years, inclusive
2. Written informed consent/assent signed from parent/guardian
3. 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)
4. Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).

Exclusion Criteria:

1. Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
2. Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
3. Prior treatment with anthelmintics (eg, diethylcarbamazine \[DEC\], suramin, ivermectin or albendazole) within 4 weeks before planned test article administration.
4. Received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.
5. Known or suspected allergy to moxidectin, ivermectin or albendazole or other compounds related to these classes of medication.
6. Pregnant (urine testing) or breastfeeding women

Primary outcomes:
measure: Cure rate against Trichuris trichiura
timeFrame: 6 weeks
Secondary outcomes:
measure: Egg Reduction Rate of the different drug regimens against Trichuris trichiura
timeFrame: 6 weeks
measure: Cure rate of the different drug regimens against Ascaris lumbricoides
timeFrame: 6 weeks
measure: Egg Reduction Rate of Ascaris lumbricoides
timeFrame: 6 weeks
measure: Cure rate against hookworm
timeFrame: 6 weeks
measure: Egg Reduction Rate of hookworm
timeFrame: 6 weeks
measure: Number of adverse events at 5 time points
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chake Chake
country: Tanzania
facility: Public Health Laboratory Ivo de Carneri, P.O. Box 122
state: Pemba
Study officials:
References:
citation: 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.