Equivalence trial of tribendimidine versus albendazole against hookworm infections in Ivory Coast

ISRCTN	ISRCTN82278211
DOI	https://doi.org/10.1186/ISRCTN82278211
Secondary identifying numbers	PPOOB-102883

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Eliezer N'Goran
Scientific

Laboratory of Zoology
UFR Biosciences
University of Cocody
22 BP 682
Abidjan
22
Côte d'Ivoire

Phone	+225 05 07 65 81
Email	eliezerngoran@yahoo.fr

Study design	Curative, randomized, double-blind, equivalence, clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	TribenAlben
Study objectives	Tribendimidine is not inferior to albendazole in curing hookworm infections in young adult males
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	26/01/2006
Completion date	30/09/2006

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	450 (225 per treatment group)
Key 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
Key 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
Date of first enrolment	26/01/2006
Date of final enrolment	30/09/2006

Laboratory of Zoology

Abidjan
22
Côte d'Ivoire

Swiss Tropical Institute (Switzerland)
Government

P.O. Box Socinstrasse 57
Basel
4002
Switzerland

Government

Swiss Tropical Institute (core funding)

No information available

Swiss National Science Foundation (PPOB-102883)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
Location: Switzerland

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan