Efficacy and Safety of a Multi-dose Regimen of Mebendazole Against Hookworm in Children
Condition: Hookworm
MeSH terms: Hookworm Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a double-blind randomized clinical trial which aims at providing evidence on
      the efficacy and safety of two regimens of mebendazole in school-aged children. Thus, our
      primary objective is to assess the efficacy and safety of: i) 100 mg solid tablets twice a
      day for 3 days, and ii) one dose of 500 mg solid tablets of mebendazole in participants aged
      6-12, inclusive, infected with hookworm.

      The primary endpoint of the trial is the cure rate (CR) of the 3-day regimen of mebendazole
      against hookworm and a single dose mebendazole treatment.

      The secondary objectives are to determine if the multi-dose regimen is superior to the single
      dose regimen, evaluate the efficacy against concomitant soil-transmitted helminth infections,
      and assess the safety of both mebendazole regimens.

      After obtaining informed consent from children's caregiver, the medical history of the
      participating individuals will be assessed with a standardized questionnaire, in addition to
      a clinical examination carried out by the study physician on the treatment day. Enrollment
      will be based on two stool samples which will be collected, if possible, on two consecutive
      days or otherwise within a maximum of 5 days apart. All stool samples will be examined with
      duplicated Kato-Katz thick smears by experienced laboratory technicians.

      Randomization of participants into the two treatment arms will be stratified according to
      intensity of infection. Participants will be interviewed before treatment for clinical
      symptoms and 3 hours after every morning treatment and 24 hours after every morning treatment
      about the occurrence of adverse events. The efficacy of the treatment will be determined
      14-21 days post-treatment by collecting another two stool samples.

      The primary analysis will include all participants with primary end point data (available
      case analysis). Supplementary, two sensitivity analyses will be conducted imputing all
      missing endpoint data as treatment failures or all as treatment success. CRs will be
      calculated as the percentage of egg-positive participants at baseline who become egg-negative
      after treatment. CRs will be compared by using unadjusted logistic regression. To assess
      model robustness with respect to covariates, adjusted logistic regressions (adjustment for
      age, sex, school, weight and strata) will be performed.

      Geometric and arithmetic mean egg counts will be calculated for the different treatment arms
      before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with
      5,000 replicates will be used to calculate 95% confidence intervals (CIs) for ERRs and the
      difference of the ERRs.
    


Intervention name(s): Treatment with one of the two regimens of mebendazole
Intervention type(s): Drug
Intervention description(s): Once in the morning and once in the evening for 3 consecutive days
Intervention MeSH terms: Mebendazole; Piperazine; Piperazine citrate; DMP 777
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment