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Completed

NCT Number: NCT00659997

Efficacy Albendazole and Levamisole Against STH on Unguja

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.

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Key information

Conditions

Ascariasis Adenophorea Infections Ascaridida Infections Enoplida Infections Helminthiasis Infections Nematode Infections Parasitic Diseases Secernentea Infections Trichuriasis

Age range

1 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Helminth Control Laboratory Unguja

Stone Town, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presently with soil-transmitted helminthiasis

Exclusion criteria

  • absence of soil-transmitted helminthiasis

Treatment and study plan

Albendazole

Drug

Single oral dose of 400mg

Levamisole

Drug

Single oral dose of 2.5mg/kg

Primary outcomes

  1. Clearance of STH faecal eggs in patient stool

    Time frame: 18 days

Sponsors and collaborators

Lead sponsor

Natural History Museum, United Kingdom

Other Gov

Collaborators

  • Ministry of Health, Tanzania
  • University of London

Registry information

Official study title

Longitudinal Study of Efficacy of Standard Albendazole Treatment Versus Levamisole/Pyrantel Pamoate on Soil Transmitted Helminth Infections

Acronym: ALBvLEV

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Apr 17, 2008
Registry last updated
Apr 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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