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Efficacy Albendazole and Levamisole Against STH on Unguja

NCT00659997 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-04-17

No results posted yet for this study

Summary

Field epidemiological studies undertaken during 2005 in four village locations in Northern Unguja, Zanzibar examined mothers and their pre-school aged children for helminth infections.

The prevalence of Ascaris lumbricoides was found to have remained relatively high despite community-wide treatment with the mass administration of Albendazole (a WHO recommended de-wormer) in coordination with community vitamin A supplementation.

One hypothesis for this is that the children and mothers had Ascaris infections more tolerant to Albendazole that subsequently failed to clear. It is necessary to compare the present drug efficiency of Albendazole (first-line de-wormer) with Levamisole (second-line de-wormer) on STH infections such patients a case-control setting to shed light on the putative resistance of local Ascaris/Trichuris to albendazole.

In so doing, this should clarify whether there is resistance developing towards Albendazole and have possible implications for introducing combination therapies of Levamisole and Albendazole for first line de-worming mothers and their children in the future.

Conditions

  • Ascariasis
  • Trichuriasis

Interventions

DRUG

Albendazole

Single oral dose of 400mg

DRUG

Levamisole

Single oral dose of 2.5mg/kg

Sponsors & Collaborators

  • Ministry of Health, Tanzania

    collaborator OTHER_GOV

  • University of London

    collaborator OTHER

  • Natural History Museum, United Kingdom

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2006-09-30
Completion
2007-09-30

Countries

  • Tanzania

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 NCT00659997 on ClinicalTrials.gov