Clinical Trials Logo

Clinical Trial Summary

Soil-transmitted helminths (STHs) infections are common in subtropics and mostly affect the poorest communities, with an impact on human health in many parts of the world. In 2017, World Health organization (WHO) reports more than 1.5 billion people are infected with soil-transmitted helminths worldwide, including 568 million school-age children who need treatment and preventive interventions. Preventive chemotherapy and periodic mass administration with benzimidazoles (BZ) [albendazole (ABZ) and mebendazole (MBZ)] are used to control these parasites. However, rapid reinfection with Ascaris lumbricoides within six months after a completed treatment has been reported, while the reinfection with hookworms is slow. Similarly, the efficacy of these drugs on Trichuris trichiura cure rate is poor. After many years of use of this drug class, there is an increase possibility that BZ resistance could develop. This resistance may occur due to single nucleotide polymorphisms (SNPs) in the β-tubulin gene at positions 167, 198 or 200, as has been reported in animals. Little data exist to show whether any of these polymorphisms do influence the BZ efficacy against STH in humans. The present study will develop methods to look for molecular evidence of BZ drug resistance in human population in order to support the investigation of the control and elimination of neglected tropical diseases (NTDs) in our communities.


Clinical Trial Description

A Randomized Controlled Clinical Trial (RCT) cohort study, to evaluate the efficacy and safety of three benzimidazole derivates drug (Albendazole, Mebendazole, Albendazole Mebendazole, and Albendazole-Pyrantel) to treat major STH in school aged children from Lambaréné and surroundings. After obtaining informed consent from parents or guardians, stool samples will be collected, for infectious status. If positive the participant will be treated with either drug combination. The efficacy and SNP frequencies will be assessed at weeks 3 and 6 post treatment Description of study population Children of school and preschool age (2 to 17 years old) living in Lambaréné and the surrounding areas are eligible. The choice of school and preschool-aged children is based on the fact that they constitute the main population at risk of infection. In addition, most of the resources available for public health interventions in many endemic areas of soil-transmitted helminths target this group as a cost-effective method for reaching a large part of the population. The previous analysis of patient cohort reported a success rate of 61% multispecies prevalence amongst children in the study area and considering a significance level of 95% confidence interval (α =5%) and a minimum power of 80%, the investigators will have to include a total of 255 participants in the study ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04326868
Study type Interventional
Source Centre de Recherche Médicale de Lambaréné
Contact
Status Completed
Phase Phase 4
Start date November 11, 2019
Completion date January 30, 2021

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Terminated NCT00319150 - REPEAT Study - Resistance to ErythroPoietin Effectiveness Algorithm Trial Phase 3
Completed NCT00563875 - Laboratory Aspirin Resistance in Diabetics and Non-Diabetics N/A
Completed NCT00389129 - Danish Aspirin Resistance Trial - Pilot Study N/A
Terminated NCT00193947 - An Evaluation of the Development of Nevirapine Induced Mutations in HIV Patients Initiating or Discontinuing Combination Antiretroviral Therapy Phase 4
Enrolling by invitation NCT06037564 - B-free Multistage Trial Phase 4
Completed NCT01039480 - Aspirin and Clopidogrel Resistance Study N/A
Recruiting NCT05310370 - HRD and Resistance to PAPPi in EOC Patients
Active, not recruiting NCT00457236 - Effect of Clopidogrel Loading and Risk of PCI N/A
Completed NCT02792816 - Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar N/A
Completed NCT01386476 - (18F)FCWAY and the Blood-Brain Barrier
Recruiting NCT04990596 - Mechanisms fo Clopidogrel Resistance in Older Adults (CEPAGE)
Recruiting NCT03401957 - The Emergence of RAS Mutations in Metastatic Colorectal Cancer Patients Receiving Cetuximab Treatment N/A
Completed NCT04404582 - Clinical Characteristics for the Critical Ill Patients With Klebsiella Pneumoniae Infection
Completed NCT02401204 - Bacterial Transmission Dynamics Study
Completed NCT03114098 - Pharmacogenetics Anomaly Research in Children and Adolescents With Pharmacological Resistance to Psychotropic Drugs N/A
Recruiting NCT03361267 - Comparison of Bismuth Containing Quadruple Therapy and Based Tailored Therapy for H. Pylori Infection N/A
Completed NCT00302913 - Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition N/A
Completed NCT04833231 - The Relationship Between Renal Functions and Multi Drug Resistant Organisms
Completed NCT00965042 - Effect of Ceftobiprole on Human Intestinal Microflora Phase 1