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Triple Combinations Against Hookworm Infections in Lao

NCT03278431 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2018-05-08

No results posted yet for this study

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.

Conditions

  • Hookworm Infection

Interventions

DRUG

Albendazole

Albendazole (400 mg) from Janssen, donated by the World Health Organization

DRUG

Pyrantel Pamoate

Pyrantel pamoate (20 mg/kg), will be purchased by the World Health Organization

DRUG

Oxantel Pamoate

Oxantel pamoate (20mg/kg) will be produced by the University of Basel

DRUG

Mebendazole

Mebendazole (500 mg) from GlaxoSmithKline, donated by the World Health Organization

Sponsors & Collaborators

  • Swiss Tropical & Public Health Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Laos

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03278431 on ClinicalTrials.gov