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| Sponsor: | Natural History Museum, United Kingdom |
|---|---|
| Collaborators: |
Ministry of Health, Tanzania University of London |
| Information provided by: | Natural History Museum, United Kingdom |
| ClinicalTrials.gov Identifier: | NCT00659997 |
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 IV |
| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| 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 |
|
Ascariasis Trichuriasis Drug resistance |
|
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 |
