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 measure
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 (if study stopped)
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
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, SNSF, FNS
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
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