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Efficacy Albendazole and Levamisole Against STH on Unguja (ALBvLEV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00659997
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : April 17, 2008
Ministry of Health, Tanzania
University of London
Information provided by:
Natural History Museum, United Kingdom

Brief 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.

Condition or disease Intervention/treatment Phase
Ascariasis Trichuriasis Drug: Albendazole Drug: Levamisole Phase 4

Detailed Description:

The study was conducted in 10 villages on Unguja Island representative of urban, semi-urban and rural environments. After liaison with the local Shehia (the elected community leader) mothers and their children aged between 6 months and 5 years old were invited to attend a walk-in mobile clinic. In accordance with WHO sample size recommendations of 30 individuals per site and to cater for drop-out/non-compliance, target enrolment was about 50 mother and child pairs at each study village.

Stool specimens were transported to the Helmtin Control Laboratory Unguja laboratory for visual inspection of stool consistency and presence of blood, after which a single Kato-Katz thick smear (41.7mg) was prepared. Eggs of all STH species were counted by inspection at 100x microscopy and expressed as a tally of eggs per gram (EPG). To ensure consistency of egg counts, slides were read by the same two technicians for each study village.

10 Mother and child pairs found positive for Ascaris and/or Trichuris were randomised, by coin tossing, to receive either a single tablet of ALB (400mg) or an appropriate dose of LEV (2.5 mg/kg). A parasitological follow-up took place 18 days after treatment where a requested stool sample was analyzed by a single Kato-Katz thick smear for assessment of STH clearance. In accordance with WHO's 'no survey without service' all attendees were given an additional ALB tablet.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Longitudinal Study of Efficacy of Standard Albendazole Treatment Versus Levamisole/Pyrantel Pamoate on Soil Transmitted Helminth Infections
Study Start Date : June 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
1 Individuals treated with Albendazole
Drug: Albendazole
Single oral dose of 400mg

Active Comparator: 2
Individuals treated with Levamisole
Drug: Levamisole
Single oral dose of 2.5mg/kg

Primary Outcome Measures :
  1. Clearance of STH faecal eggs in patient stool [ Time Frame: 18 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Presently with soil-transmitted helminthiasis

Exclusion Criteria:

  • absence of soil-transmitted helminthiasis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00659997

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Helminth Control Laboratory Unguja
Stone Town, Tanzania
Sponsors and Collaborators
Natural History Museum, United Kingdom
Ministry of Health, Tanzania
University of London

Publications of Results:
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Responsible Party: Prof D Rollinson, Natural History Museum Identifier: NCT00659997    
Other Study ID Numbers: NHMDEWORMING
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: April 17, 2008
Last Verified: April 2008
Keywords provided by Natural History Museum, United Kingdom:
Drug resistance
Additional relevant MeSH terms:
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Enoplida Infections
Adenophorea Infections
Nematode Infections
Parasitic Diseases
Ascaridida Infections
Secernentea Infections
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antinematodal Agents
Antirheumatic Agents