Condition category
Infections and Infestations
Date applied
18/02/2009
Date assigned
24/02/2009
Last edited
24/09/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sti.ch

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes