drugset / Trial / NCT03278431

Triple Combinations Against Hookworm Infections in Lao

NCT03278431

Phase 4 Completed 420 enrolled Swiss Tropical & Public Health Institute
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2017-09-27
Primary completion
2017-11-17
Completion
2017-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Albendazole Small molecule 400 mg
Subject Mebendazole Small molecule 500 mg
Subject Oxantel Pamoate Unknown 20 mg/kg
Subject Pyrantel Pamoate Unknown 20 mg/kg