NCT04326868: BenziR

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

Completed Phase 4 Last updated 2 August 2021

What this trial tests

Phase 4 trial testing Benzimidazole Anthelmintic in Helminths Infection in 255 participants. Completed in 30 January 2021.

Timeline

11 November 2019

Primary endpoint
31 December 2020

30 January 2021

Quick facts

Lead sponsor	Centre de Recherche Médicale de Lambaréné
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	255
Start date	11 November 2019
Primary completion	31 December 2020
Estimated completion	30 January 2021
Sites	1 location across Gabon

Drugs / interventions tested

• Benzimidazole Anthelmintic — full drug profile →

Conditions studied

• Helminths Infection — all drugs for Helminths Infection →
• Drug Resistance — all drugs for Drug Resistance →

Sponsor

Centre de Recherche Médicale de Lambaréné — full company profile →

Who can join

Adults 2 to 17, any sex, with Helminths Infection or Drug Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A randomized assessors-blind clinical trial to evaluate the safety and the efficacy of albendazole alone and in combination with mebendazole or pyrantel for the treatment of <i>Trichuris trichiura</i> infection in school-aged children in Lambaréné and surroundings.
   Nguema Moure PA, Nzamba Maloum M, Manouana GP, Laclong Lontchi R-A, et al · · 2024 · cited 4× · PMID 38563751 · DOI 10.1128/aac.01211-23
2. Molecular-based assessment of the efficacy of anthelminthic combination regimens for the treatment of Strongyloides stercoralis in Gabon.
   Dejon Agobé JC, Nguema-Moure PA, Manouana GP, Laclong Lontchi RA, et al · · 2025 · PMID 41364144 · DOI 10.1007/s00436-025-08610-0