Efficacy Albendazole and Levamisole Against STH on Unguja (ALBvLEV)

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Tanzania
University of London
Information provided by:
Natural History Museum, United Kingdom
ClinicalTrials.gov Identifier:
NCT00659997
First received: April 10, 2008
Last updated: April 15, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Ascariasis
Trichuriasis
Drug: Albendazole
Drug: Levamisole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Longitudinal Study of Efficacy of Standard Albendazole Treatment Versus Levamisole/Pyrantel Pamoate on Soil Transmitted Helminth Infections

Resource links provided by NLM:


Further study details as provided by Natural History Museum, United Kingdom:

Primary Outcome Measures:
  • Clearance of STH faecal eggs in patient stool [ Time Frame: 18 days ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2006
Study Completion Date: September 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   1 Year to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presently with soil-transmitted helminthiasis

Exclusion Criteria:

  • absence of soil-transmitted helminthiasis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659997

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

No publications provided

Responsible Party: Prof D Rollinson, Natural History Museum
ClinicalTrials.gov Identifier: NCT00659997     History of Changes
Other Study ID Numbers: NHMDEWORMING
Study First Received: April 10, 2008
Last Updated: April 15, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Natural History Museum, United Kingdom:
Ascariasis
Trichuriasis
Drug resistance

Additional relevant MeSH terms:
Ascariasis
Ascaridiasis
Trichuriasis
Ascaridida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Enoplida Infections
Adenophorea Infections
Albendazole
Levamisole
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on April 17, 2014