Condition category
Infections and Infestations
Date applied
16/08/2008
Date assigned
21/08/2008
Last edited
13/11/2008
Prospective/Retrospective
Retrospectively 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

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 measures

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

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

http://www.snf.ch

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, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/pubmed/18923706

Publication citations

  1. 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.

Additional files

Editorial Notes