Contact information
Type
Scientific
Primary contact
Dr Juerg Utzinger
ORCID ID
Contact details
Department of Public Health and Epidemiology
Swiss Tropical Institute
Socinstrasse 57
PO Box
Basel
4002
Switzerland
+41 61 284 8129
juerg.utzinger@unibas.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
1. Single-dose albendazole and single-dose tribendimidine (both drugs will be administered orally at 200 mg for children aged 5-14 years, and 400 mg for individuals aged >=15 years) are safe and efficacious against soil-transmitted helminth infections (Ascaris lumbricoides, hookworm and Trichuris trichuria)
2. Single-dose tribendimidine has an effect on Strongyloides stercoralis and Taenia spp
Ethics approval
Ethics Committee of the University and the State of Basel (Ethikkommission beider Basel) (EKBB) Date of approval: 12/06/2007 (ref: 149/07)
Study design
Open-label, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Not Specified
Patient information sheet
Condition
Helminth infections
Intervention
The participants who were diagnosed with helminthiases at the baseline parasitological survey were randomly allocated to the following arms:
Arm 1: Single-dose albendazole (oral), 200 mg for children aged 5-14 years, and 400 mg for individuals aged >=15 years
Arm 2: Single-dose tribendimidine (oral), 200 mg for children aged 5-14 years, and 400 mg for individuals aged >=15 years
Intervention type
Drug
Phase
Not Specified
Drug names
Albendazole, tribendimidine
Primary outcome measure
1. Reduction of infection prevalence of intestinal helminths, assessed by examination of stool samples 2-4 weeks after drug administration
2. Frequency and severity of adverse events were recorded within 24 hours after drug administration
Secondary outcome measures
Kato-Katz-derived egg count reduction of common soil-transmitted helminths, assessed 2-4 weeks after drug administration.
Overall trial start date
01/05/2007
Overall trial end date
31/07/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, age >=5 years
2. Submission of >=1 stool sample for the baseline parasitological survey
3. For females, not pregnant, as verbally assessed by medical personnel on the day of treatment
4. Absence of major systemic illnesses, as assessed by medical personnel on the day of treatment
5. Written informed consent by the head of the household on behalf of the whole family
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Approximately 300
Participant exclusion criteria
1. Presence of any abnormal medical condition, as judged by the medical personnel
2. No stool sample submitted for baseline parasitological survey
3. Enrolled in any other clinical investigation during the study
4. For females: pregnancy
Recruitment start date
01/05/2007
Recruitment end date
31/07/2007
Locations
Countries of recruitment
China
Trial participating centre
Department of Public Health and Epidemiology
Basel
4002
Switzerland
Sponsor information
Organisation
Swiss National Science Foundation (SNSF) (Switzerland)
Sponsor details
Wildhainweg 3
PO Box 8232
Bern
3001
Switzerland
+41 31 308 22 22
info@snf.ch
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Main funder:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Commission for Research Partnership with Developing Countries (KFPE) through the Swiss Agency for Development and Cooperation (SDC) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Other funders:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Voluntary Academic Society (Freiwillige Akademische Gesellschaft) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Janggen-Pöhn Foundation (Janggen-Pöhn-Stiftung) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Chinese Ministry of Science and Technology, through their support to the Key Laboratory of Parasite and Vector Biology of the Chinese Ministry of Health (China) (grant ref: 2005DKA21104)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Swiss National Science Foundation (Switzerland) (project numbers PPOOB-102883 and PPOOB-119129)
Alternative name(s)
Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNSF, FNS, SNF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Switzerland
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
Basic results (scientific)
Publication list
Results in: http://www.ncbi.nlm.nih.gov/pubmed/18923706
Publication citations
-
Results
Steinmann P, Zhou XN, Du ZW, Jiang JY, Xiao SH, Wu ZX, Zhou H, Utzinger J, Tribendimidine and albendazole for treating soil-transmitted helminths, Strongyloides stercoralis and Taenia spp.: open-label randomized trial., PLoS Negl Trop Dis, 2008, 2, 10, e322, doi: 10.1371/journal.pntd.0000322.