Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06188715
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2023-12-18
Brief Title:
Efficacy and Safety of MOXALB Co-administration in SAC
Sponsor:
Jennifer Keiser
Organization:
Swiss Tropical Public Health Institute
Study Overview
Official Title:
Efficacy and Safety of Moxidectin-albendazole Combination for Trichuris Trichiura Infections in School-aged Children a Double-blind Randomised Controlled Superiority Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Moxiped
Brief 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
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
Detailed 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 moxidectinalbendazole 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 andor 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 5000 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
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 moxidectinalbendazole 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 andor 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 5000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None