Clinical trial NCT04326868: Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon
Official title: Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helminths Infection
Drug Resistance
Keywords: Helminths
Resistance
Gabon
Infection
CERMEL
Benzimidazole
Lead sponsor: Centre de Recherche Médicale de Lambaréné
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 255
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants diagnosed positive for Soil Helminths Infection 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. These regimens consisted of treatment as follow: given as a single tablet once daily for 3 consecutive days

* A single tablet of ABZ (400mg), administered during 3 consecutive days;
* 1 tablet of ABZ 400mg + 1 tablet of MBZ (500mg) administered in 3 consecutive days,
* 1 tablet of ABZ (400mg) + Pyr (125 mg) administered in 3 consecutive days
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of eggs rate reduction .
timeFrame: three weeks to six weeks
measure: Assessment of cure rate
timeFrame: three weeks to six weeks
Secondary outcomes:
measure: The assessment of safety
timeFrame: three to six weeks.
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Centre de Recherches Médicales de Lammbaréné
state: Moyen- Ogooué
Study officials:
affiliation: Centre de Recherche Médicale de Lambaréné
name: Ayôla Akim ADEGNIKA
role: PRINCIPAL_INVESTIGATOR
References: