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

NCT04326868 | Completed Phase 4 FDA Drug

• 2 other identifiers: 0084/2019/PR/SG/CNERCEI- 007/2019
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

Helminths Infection; Drug Resistance

Keywords

Helminths; Resistance; Gabon; Infection; CERMEL; Benzimidazole

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• The assessment of safety

  three to six weeks.

Study Arms (3)

Albendazole

ACTIVE COMPARATOR

ABZ (400mg)

Drug: Benzimidazole Anthelmintic

Albendazole and Mebendazole

EXPERIMENTAL

ABZ 400mg + 1 tablet of MBZ (500mg)

Drug: Benzimidazole Anthelmintic

Albendazole and Pyrantel

EXPERIMENTAL

ABZ (400mg) + Pyr (125 mg)

Drug: Benzimidazole Anthelmintic

Interventions

Benzimidazole Anthelmintic DRUG

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.

Also known as: Albendazole, Mebendazole, Pyrantel

Albendazole; Albendazole and Mebendazole; Albendazole and Pyrantel

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Living in Lambaréné and surrounding areas
• Written informed consent or assent
• Microscopy positive for any major Soil-Transmitted helminths

You may not qualify if:

• Microscopy negative for any STH
• Pregnant women
• Do not be available for followed up.

Sponsors & Collaborators

• Centre de Recherche Médicale de Lambaréné: lead

Study Sites (1)

Centre de Recherches Médicales de Lammbaréné

Lambaréné, Moyen-Ogooué Province, 1437, Gabon

Location

Related Publications (1)

• Nguema Moure PA, Nzamba Maloum M, Manouana GP, Laclong Lontchi R-A, Mbong Ngwese M, Edoa JR, Frejus Zinsou J, Meulah B, Mahmoudou S, N'noh Dansou EM, Josiane Honkpehedji Y, Romeo Adegbite B, Agnandji ST, Ramharter M, Lell B, Borrmann S, Kremsner PG, Dejon-Agobe JC, Adegnika AA. 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 Trichuris trichiura infection in school-aged children in Lambarene and surroundings. Antimicrob Agents Chemother. 2024 May 2;68(5):e0121123. doi: 10.1128/aac.01211-23. Epub 2024 Apr 2.

  PMID: 38563751 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Albendazole; Mebendazole; Pyrantel

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ayôla Akim ADEGNIKA

  Centre de Recherche Médicale de Lambaréné

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 30, 2020
• Study Start: November 11, 2019
• Primary Completion: December 31, 2020
• Study Completion: January 30, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The date will be available around December 2020 until september 2021.
• Access Criteria: The Data will be shared12 months after study completion in research journal. A lle the result will be publicly available the

Locations

GA (1)