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Efficacy Albendazole and Levamisole Against STH on Unguja (ALBvLEV)

Primary Purpose

Ascariasis, Trichuriasis

Status
Completed
Phase
Phase 4
Locations
Tanzania
Study Type
Interventional
Intervention
Albendazole
Levamisole
Sponsored by
Natural History Museum, United Kingdom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ascariasis focused on measuring Ascariasis, Trichuriasis, Drug resistance

Eligibility Criteria

1 Year - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Presently with soil-transmitted helminthiasis

Exclusion Criteria:

  • absence of soil-transmitted helminthiasis

Sites / Locations

  • Helminth Control Laboratory Unguja

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

1 Individuals treated with Albendazole

Individuals treated with Levamisole

Outcomes

Primary Outcome Measures

Clearance of STH faecal eggs in patient stool

Secondary Outcome Measures

Full Information

First Posted
April 10, 2008
Last Updated
April 15, 2008
Sponsor
Natural History Museum, United Kingdom
Collaborators
Ministry of Health, Tanzania, University of London
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1. Study Identification

Unique Protocol Identification Number
NCT00659997
Brief Title
Efficacy Albendazole and Levamisole Against STH on Unguja
Acronym
ALBvLEV
Official Title
Longitudinal Study of Efficacy of Standard Albendazole Treatment Versus Levamisole/Pyrantel Pamoate on Soil Transmitted Helminth Infections
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Natural History Museum, United Kingdom
Collaborators
Ministry of Health, Tanzania, University of London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascariasis, Trichuriasis
Keywords
Ascariasis, Trichuriasis, Drug resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
1 Individuals treated with Albendazole
Arm Title
2
Arm Type
Active Comparator
Arm Description
Individuals treated with Levamisole
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Description
Single oral dose of 400mg
Intervention Type
Drug
Intervention Name(s)
Levamisole
Intervention Description
Single oral dose of 2.5mg/kg
Primary Outcome Measure Information:
Title
Clearance of STH faecal eggs in patient stool
Time Frame
18 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presently with soil-transmitted helminthiasis Exclusion Criteria: absence of soil-transmitted helminthiasis
Facility Information:
Facility Name
Helminth Control Laboratory Unguja
City
Stone Town
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
18775092
Citation
Stothard JR, Imison E, French MD, Sousa-Figueiredo JC, Khamis IS, Rollinson D. Soil-transmitted helminthiasis among mothers and their pre-school children on Unguja Island, Zanzibar with emphasis upon ascariasis. Parasitology. 2008 Oct;135(12):1447-55. doi: 10.1017/S0031182008004836. Epub 2008 Sep 8.
Results Reference
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Efficacy Albendazole and Levamisole Against STH on Unguja

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