Condition category
Infections and Infestations
Date applied
21/01/2006
Date assigned
24/01/2006
Last edited
25/08/2011
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 Eliezer N'Goran

ORCID ID

Contact details

Laboratory of Zoology
UFR Biosciences
University of Cocody
22 BP 682
Abidjan
22
Cote d'Ivoire
+225 05 07 65 81
eliezerngoran@yahoo.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PPOOB-102883

Study information

Scientific title

Acronym

TribenAlben

Study hypothesis

Tribendimidine is not inferior to albendazole in curing hookworm infections in young adult males

Ethics approval

Ethics review of the clinical trial protocol was conducted by the Minister of Population and Health, Republic of Ivory Coast (Ministere de la Sante et de la Population, Republique de Cote d'Ivoire) and approved according to document number 314/MEMSP/DGPS/DEPS/S-DPM on 20/07/2005

Study design

Curative, randomized, double-blind, equivalence, clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hookworm infection (Necator americanus and Ancylostoma duodenale)

Intervention

Intervention group: single oral dose of 400 mg tribendimidine
Control group: single oral dose of 400 mg albendazole

Intervention type

Drug

Phase

Not Specified

Drug names

Tribendimidine
Albendazole

Primary outcome measures

1. Cure rate at 21 day post-administration
2. Egg reduction rate at 21 day post-administration
3. Observed acute adverse events within 1-3 hours and solicited adverse events within 24 hours

Secondary outcome measures

Rate of perceived illness episodes throughout the 6 months follow-up period with 1 week recall period

Overall trial start date

26/01/2006

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Hookworm egg positive adult males (16-45 years) recruited at community survey in the region of Agboville (south Ivory Coast ) with written informed consent

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

450 (225 per treatment group)

Participant exclusion criteria

1. Any abnormal medical condition judged by the investigating medical team
2. Hypersensitivity to albendazole or any other anthelmintic drug
3. Taken any anthelmintic drug during the last month before enrolment
4. Hookworm egg negative after 4 Kato-Katz thick smears done on two consecutive stool specimens

Recruitment start date

26/01/2006

Recruitment end date

30/09/2006

Locations

Countries of recruitment

Cote d'Ivoire

Trial participating centre

Laboratory of Zoology
Abidjan
22
Cote d'Ivoire

Sponsor information

Organisation

Swiss Tropical Institute (Switzerland)

Sponsor details

P.O. Box Socinstrasse 57
Basel
4002
Switzerland
+41 61 2848111
d.desavigny@unibas.ch

Sponsor type

Government

Website

http://www.sti.ch

Funders

Funder type

Government

Funder name

Swiss Tropical Institute (core funding)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swiss National Science Foundation (PPOB-102883)

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

Publication citations

Additional files

Editorial Notes