Contact information
Type
Scientific
Primary contact
Prof Juerg Utzinger
ORCID ID
Contact details
Department of Public Health and Epidemiology
Swiss Tropical Institute
P.O. Box
Basel
4002
Switzerland
+41 (0)61 284 8129
juerg.utzinger@unibas.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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
Ethics approval
Ethikkommission beider Basel EKBB gave approval on the 15th January 2009 (ref: 13/09)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Soil-transmitted helminthiasis
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Albendazole, mebendazole, ivermectin
Primary outcome measures
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 measures
Cure rate and egg reduction rate of Ascaris lumbricoides and hookworm
Overall trial start date
01/03/2009
Overall trial end date
31/05/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
2000 children screened for helminth infections; ~600 children treated with anthelminthic drugs
Participant 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
Recruitment start date
01/03/2009
Recruitment end date
31/05/2009
Locations
Countries of recruitment
Tanzania
Trial participating centre
Department of Public Health and Epidemiology
Basel
4002
Switzerland
Sponsor information
Organisation
Swiss Tropical Institute (STI) (Switzerland)
Sponsor details
c/o Juerg Utzinger
Department of Public Health and Epidemiology
P.O. Box
Basel
4002
Switzerland
+41 (0)61 284 8129
juerg.utzinger@unibas.ch
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Commission for Research Partnerships with Developing Countries (KFPE) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Results
Knopp S, Mohammed KA, Speich B, Hattendorf J, Khamis IS, Khamis AN, Stothard JR, Rollinson D, Marti H, Utzinger J, Albendazole and mebendazole administered alone or in combination with ivermectin against Trichuris trichiura: a randomized controlled trial., Clin. Infect. Dis., 2010, 51, 12, 1420-1428, doi: 10.1086/657310.
-
Results
Knopp S, Speich B, Hattendorf J, Rinaldi L, Mohammed KA, Khamis IS, Mohammed AS, Albonico M, Rollinson D, Marti H, Cringoli G, Utzinger J, Diagnostic accuracy of Kato-Katz and FLOTAC for assessing anthelmintic drug efficacy., PLoS Negl Trop Dis, 2011, 5, 4, e1036, doi: 10.1371/journal.pntd.0001036.
-
Results
Speich B, Ame SM, Ali SM, Alles R, Hattendorf J, Utzinger J, Albonico M, Keiser J, Efficacy and safety of nitazoxanide, albendazole, and nitazoxanide-albendazole against Trichuris trichiura infection: a randomized controlled trial., PLoS Negl Trop Dis, 2012, 6, 6, e1685, doi: 10.1371/journal.pntd.0001685.