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

ISRCTN	ISRCTN82278211
DOI	https://doi.org/10.1186/ISRCTN82278211
Protocol serial number	PPOOB-102883
Sponsor	Swiss Tropical Institute (Switzerland)
Funders	Swiss Tropical Institute (core funding), Swiss National Science Foundation (PPOB-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

Primary study design	Interventional
Study design	Curative, randomized, double-blind, equivalence, clinical trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Tribendimidine Albendazole
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Rate of perceived illness episodes throughout the 6 months follow-up period with 1 week recall period
Completion date	30/09/2006

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	450
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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan