Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon
Condition: Helminths Infection; Drug Resistance
MeSH terms: Helminthiasis
Study type: Interventional
Phase: Phase 4

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
    

Intervention name(s): Benzimidazole Anthelmintic
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Albendazole; Mebendazole; Pyrantel
Intervention MeSH terms: Albendazole; Mebendazole; Benzimidazole; Pyrantel; Anthelmintics
Allocation: Randomized
Intervention model: Parallel Assignment
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
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Helminths; Resistance; Gabon; Infection; CERMEL; Benzimidazole