Triple Combinations Against Hookworm Infections in Lao
Condition: Hookworm Infection
MeSH terms: Infections; Communicable Diseases; Hookworm Infections; Ancylostomiasis
Study type: Interventional
Phase: Phase 4

Summary: 
      More than one billion people are infected with soil-transmitted helminths (STH, A.
      lumbricoides, hookworm or Trichuris trichiura). Preventive chemotherapy - i.e. annual or
      biannual treatment of at-risk populations with albendazole or mebendazole is the current
      strategy against STH. However, the efficacy of both drugs is only moderate against hookworm
      and low against T. trichiura. For increasing the efficacy and to avoid drug resistance, new
      drugs or the combination of different drugs is the way forward.

      In this randomised controlled trial, we assess the efficacy (based on cure rates) of
      different drug combinations in school-aged children in Lao. 420 hookworm positive children
      will be treated: 140 with albendazole-oxantel pamoate, 140 with albendazole-pyrantel
      pamoate-oxantel pamoate treatment arms, 70 with pyrantel pamoate-oxantel pamoate and 70 with
      mebendazole-pyrantel pamoate-oxantel pamoate. Two stool samples will be collected at baseline
      and follow-up (14-21 days after treatment) and analysed with Kato-Katz.
    

Detailed description: 
      More than one billion people are infected with A. lumbricoides, hookworm or Trichuris
      trichiura, the so-called soil-transmitted helminths (STH). Preventive chemotherapy - i.e.
      annual or biannual treatment of at-risk populations, is the current strategy against STH
      advocated by the World Health Organization. However, the currently used drugs albendazole and
      mebendazole have only moderate efficacy against hookworm and low against T. trichiura. The
      main challenge is their temporal decrease in efficacy, which might be associated with drug
      resistance, as it was shown in veterinary medicine. For increasing the efficacy and to avoid
      drug resistance, new drugs or the combination of different drugs is the way forward.

      The primary objective of this study is to assess the efficacy (based on cure rates [CR]) of
      the three combinations, i.e. albendazole-oxantel pamoate, pyrantel pamoate-oxantel pamoate
      and albendazole-pyrantel pamoate-oxantel pamoate in school-aged children infected with
      hookworms in Laos. Secondary objectives include; i) a proof of concept, investigating the
      difference between the two triple combinations albendazole-pyrantel pamoate-oxantel pamoate
      versus mebendazole-pyrantel pamoate-oxantel pamoate (based on CRs), ii) egg reduction rates
      (ERR) against hookworm and ERRs/CRs against A. lumbricoides and T. trichiura and iii)
      tolerability of the 4 combinations.

      Two stool samples will be collected from school-aged children (age 6-15) at baseline. 420
      hookworm positive children will be treated: 140 with albendazole-oxantel pamoate, 140 with
      albendazole-pyrantel pamoate-oxantel pamoate, 70 with pyrantel pamoate-oxantel pamoate and 70
      with mebendazole-pyrantel pamoate-oxantel pamoate treatment arms The medical history of the
      participating children will be assessed with a standardized questionnaire, in addition to a
      clinical examination carried out by the study physician on the treatment day. Children will
      be interviewed before treatment for clinical symptoms and 3 and 24 hours after 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. All stool samples will be
      examined with duplicated Kato-Katz thick smears.
    

Intervention name(s): Albendazole; Pyrantel Pamoate; Oxantel Pamoate; Mebendazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Albendazole (400 mg) from Janssen, donated by the World Health Organization; Pyrantel pamoate (20 mg/kg), will be purchased by the World Health Organization; Oxantel pamoate (20mg/kg) will be produced by the University of Basel; Mebendazole (500 mg) from GlaxoSmithKline, donated by the World Health Organization
Intervention MeSH terms: Albendazole; Mebendazole; Piperazine; Piperazine citrate; Pyrantel; Pyrantel Pamoate; Oxantel; Oxantel pamoate; DMP 777
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment