Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon

Drug Resistance Clinical Trial

— BenziR  

Official title:

Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326868
• Other study ID #: 0084/2019/PR/SG/CNER
• Secondary ID: CEI- 007/2019
• Status: Completed
• Phase: Phase 4
• Start date: November 11, 2019
• Est. completion date: January 30, 2021

Study information

• Verified date: July 2021
• Source: Centre de Recherche Médicale de Lambaréné
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: January 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• Living in Lambaréné and surrounding areas

• Written informed consent or assent

• Microscopy positive for any major Soil-Transmitted helminths

Exclusion Criteria:

• Microscopy negative for any STH

• Pregnant women

• Do not be available for followed up.

Related Conditions & MeSH terms

• Drug Resistance
• Helminthiasis
• Helminths Infection

Intervention

Drug:
• Benzimidazole Anthelmintic
The participants diagnosed positive will be randomly assigned to one of the following treatment arms of the study. Parents or guardians of eligible children will be asked to bring them to the CERMEL (clinic). after a brief clinical examination child fulfilling inclusion criteria will be randomly assigned to one of the following treatment regimens of the study.

Locations

Country	Name	City	State
Gabon	Centre de Recherches Médicales de Lammbaréné	Lambaréné	Moyen- Ogooué

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche Médicale de Lambaréné

Country where clinical trial is conducted

Gabon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of eggs rate reduction .	The assessment of efficacy will be the level of the eggs rate reduction . The assessment will be done at weeks 3 and 6 and a different treatment regimen will be compared according to protocol and intention to treat.; This evaluation will be based on the same parasitological examinations carried out at the beginning. Using polymerase chain reaction(PCR) for a better, appreciation of the efficacy of Benzimidazole.	three weeks to six weeks
Primary	Assessment of cure rate	The assessment of efficacy as a cure rate, based on the absence of eggs at three and six weeks post treatment, using microscopy and PRC examination.	three weeks to six weeks
Secondary	The assessment of safety	The adverse events due to a drug intake and the frequency of single nucleotide polymorphisms (SNPs) before and after treatment in each group.The safety of administration of Benzimidazole will be evaluated primarily clinically. The safety will be evaluated within 24 hours and at any unscheduled visit or at week 3 and week 6 to record any symptoms that occur after the drug has been administered.	three to six weeks.