Efficacy Albendazole and Levamisole Against STH on Unguja
Information source: Natural History Museum, United Kingdom
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ascariasis; Trichuriasis
Intervention: Albendazole (Drug); Levamisole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Natural History Museum, United Kingdom
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.
Clinical Details
Official title: Longitudinal Study of Efficacy of Standard Albendazole Treatment Versus Levamisole/Pyrantel Pamoate on Soil Transmitted Helminth Infections
Study design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Primary outcome: Clearance of STH faecal eggs in patient stool
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
Minimum age: 1 Year.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Presently with soil-transmitted helminthiasis
Exclusion Criteria:
- absence of soil-transmitted helminthiasis
Locations and Contacts
Helminth Control Laboratory Unguja, Stone Town, Tanzania
Additional Information
Starting date: June 2006
Ending date: September 2007
Last updated: April 15, 2008
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