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Efficacy and safety of anti-worm drugs in schoolchildren in Zanzibar, Tanzania
ISRCTN ISRCTN08336605
DOI 10.1186/ISRCTN08336605
ClinicalTrials.gov identifier
EudraCT number
Public title Efficacy and safety of anti-worm drugs in schoolchildren in Zanzibar, Tanzania
Scientific title Efficacy and safety of albendazole and mebendazole as single-dose or in combination with ivermectin against soil-transmitted helminth infections, particularly Trichuris trichiura, in schoolchildren in Zanzibar, Tanzania: a randomised controlled trial
Acronym Alben-Meben-Ivermect-Zanzibar
Serial number at source N/A
Study hypothesis 1. Combination therapy with either albendazole or mebendazole plus ivermectin is more efficacious against Trichuris trichiura that single therapy with either albendazole or mebendazole
2. Current efficacy of either albendazole or mebendazole (single dose) is low due the long-term administration of these drugs in the national helminth control programme in Zanzibar
3. The FLOTAC® technique is more sensitive than the Kato-Katz technique for helminth egg detection
Lay summary Not provided at time of registration
Ethics approval Ethikkommission beider Basel EKBB gave approval on the 15th January 2009 (ref: 13/09)
Study design Randomised controlled trial
Countries of recruitment Tanzania
Disease/condition/study domain Soil-transmitted helminthiasis
Participants - inclusion criteria 1. Aged greater than or equal to 5 years, both sexes
2. Submission of one stool sample of sufficient size to perform a total of two thick Kato-Katz smears at the baseline parasitological survey
3. Submission of one stool sample of sufficient size to perform a total of two thick Kato-Katz smears at the day of treatment
4. Infection with Trichuris trichiura as determined with the Kato-Katz method at the baseline survey. Additionally, also children with A. lumbricoides and/or hookworm infections will be included in one of the four treatment arms.
5. For females, not pregnant, as verbally assessed by medical personnel on the day of treatment
6. Absence of major systemic illnesses, as assessed by female medical personnel on the day of treatment
7. No anthelminthic treatment in the past 4 weeks, as verbally confirmed by the participant at the baseline survey
8. Written informed consent by the parent/legal guardian
Participants - exclusion criteria 1. No stool sample given at baseline survey or day of treatment
2. No infection with T. trichiura, A. lumbricoides and/or hookworm at baseline
3. Subjects with fever or other signs of acute illness
4. Subjects with severe neurological disorder
5. Subjects with severe liver disorder
6. Pregnant schoolgirls
7. Recent history of anthelminthic treatment
8. Consent not given
Anticipated start date 01/03/2009
Anticipated end date 31/05/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 2000 children screened for helminth infections; ~600 children treated with anthelminthic drugs
Interventions Four treatment groups as follows:
1. Single-dose albendazole; children will receive one tablet of albendazole (400 mg) and a placebo resembling ivermectin (number of tablets according to weight)
2. Mebendazole; children will receive a single dose of mebendazole (500 mg) and a placebo resembling ivermectin (number of tablets according to weight)
3. Albendazole plus ivermectin; children will receive one tablet of albendazole (400 mg) plus ivermectin tablets according to their weight (200 µg/kg)
4. Mebendazole plus ivermectin; children will receive one tablet of mebendazole (500 mg) plus ivermectin tablets according to their weight (200 µg/kg)

The treatment for the four arms will be administered on a single day; follow-up is 3 - 4 weeks post-treatment.
Primary outcome measure(s) 1. Cure rate of Trichuris trichiura infection (percentage of children with egg counts greater than 0 before treatment who become negative after treatment)
2. Egg reduction rate of Trichuris trichiura infection (reduction in egg count in a measured quantity of faeces following treatment in those not cured)
Secondary outcome measure(s) Cure rate and egg reduction rate of Ascaris lumbricoides and hookworm
Sources of funding Commission for Research Partnerships with Developing Countries (KFPE) (Switzerland)
Trial website
Publications 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21062129
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21532740
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22679525
Contact name Prof  Juerg  Utzinger
  Address Department of Public Health and Epidemiology
Swiss Tropical Institute
P.O. Box
  City/town Basel
  Zip/Postcode 4002
  Country Switzerland
  Tel +41 (0)61 284 8129
  Fax +41 (0)61 284 8105
  Email juerg.utzinger@unibas.ch
Sponsor Swiss Tropical Institute (STI) (Switzerland)
  Address c/o Juerg Utzinger
Department of Public Health and Epidemiology
P.O. Box
  City/town Basel
  Zip/Postcode 4002
  Country Switzerland
  Tel +41 (0)61 284 8129
  Fax +41 (0)61 284 8105
  Email juerg.utzinger@unibas.ch
  Sponsor website: http://www.sti.ch
Date applied 18/02/2009
Last edited 24/09/2012
Date ISRCTN assigned 24/02/2009
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