Clinical Trials Logo

Clinical Trial 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 compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC. As measure of efficacy of the treatment the cure rate (percentage of eggpositive subjects at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.


Clinical Trial Description

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 compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC. The primary objective of the trial is to comparatively assess the efficacy in terms of cure rate (CR) against T. trichiura infections among SAC receiving moxidectin/albendazole combination therapy and albendazole monotherapy. The secondary objectives of the trial are to compare the egg reduction rates (ERRs) of the treatment regimens against T. trichiura, to determine the CRs and ERRs of the drugs in study participants co-infected with A. lumbricoides and hookworm, and to evaluate the safety and tolerability of the treatment regimens. In addition, this study aims to characterize population pharmacokinetics of moxidectin in T. trichiura infected SAC. After obtaining informed consent from parents and/or caregivers, the medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician before treatment. Enrollment will be based on two stool samples, which will be collected, if possible, on two consecutive days or otherwise within a maximum of 5 days. All stool samples will be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians. Randomization of participants into the six treatment arms will be stratified according to intensity of infection and age. All participants will be interviewed before treatment, and at 3 and 24 hours and 14-21 days after treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 14-21 days post-treatment by collecting another two stool samples. The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, a per-protocol analysis will be conducted. CRs will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. Differences among CRs between treatment arms will be analysed using crude and adjusted logistic regression modeling (adjustment for age, sex and weight). Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 5,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in ERRs. Adverse events will be compiled into frequency tables and compared between treatment groups using descriptive summary statistics. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06188715
Study type Interventional
Source Swiss Tropical & Public Health Institute
Contact
Status Active, not recruiting
Phase Phase 3
Start date May 14, 2024
Completion date July 2024

See also
  Status Clinical Trial Phase
Withdrawn NCT03261596 - Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana Phase 4
Completed NCT05538767 - Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm Phase 2
Completed NCT03527745 - Albendazole Dose Finding and Pharmacokinetics in Children and Adults Phase 2
Active, not recruiting NCT04227834 - Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education N/A
Completed NCT04700423 - Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration Phase 2/Phase 3
Completed NCT03172975 - Efficacy of Na-GST-1/Alhydrogel Hookworm Vaccine Assessed by Controlled Challenge Infection Phase 2
Recruiting NCT06184399 - Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC Phase 2
Completed NCT04726969 - Efficacy and Safety of MOX/ALB Co-administration Phase 3
Completed NCT03995680 - Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm Phase 2
Completed NCT05017194 - Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm Phase 2
Completed NCT01163877 - Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma N/A