International randomized controlled phase III trial of DB289 versus pentamidine for the treatment of first stage Human African Trypanosomiasis (HAT)

ISRCTN	ISRCTN85534673
DOI	https://doi.org/10.1186/ISRCTN85534673
Secondary identifying numbers	289-C-010 (C05-010)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Dr Christian Burri
Scientific

Swiss Tropical Institute
Socinstrasse 57
Basel
CH-4002
Switzerland

Phone	+41 61 225 26 61
Email	Christian.Burri@unibas.ch

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	International randomized controlled phase III trial of DB289 versus pentamidine for the treatment of first stage Human African Trypanosomiasis (HAT)
Study hypothesis	To compare the efficacy, safety and tolerability of oral DB289 versus intramuscular pentamidine, for treatment of first stage HAT caused by T. b. gambiense.
Ethics approval(s)	Not provided at time of registration
Condition	Human African Trypanosomiasis (HAT) or sleeping sickness
Intervention	The subjects will receive either DB289 or pentamidine treatment according to their randomisation.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	DB289 and pentamidine
Primary outcome measure	The primary efficacy variable will be the combined rate of clinical and parasitological cure at the Test of Cure evaluation (12 month evaluation) in the Per Protocol dataset.
Secondary outcome measures	Parasitological cure, clinical cure, probable relapse, relapse and death rates at the End of Treatment and at the 3, 6, 18 and 24 month evaluations will also be determined.
Overall study start date	15/07/2005
Overall study end date	15/12/2006

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	250
Participant inclusion criteria	1. The patient has first stage T. b. gambiense infection, i.e. parasitologically confirmed infection in the blood or lymph node aspirate and White Blood Cell count (WBC) less than or equal to 5 mm^3 detected in the CerebroSpinal Fluid (CSF) by microscopic examination. 2. Patient is male or female 12 years of age or older and more than or equal to 30 kg.
Participant exclusion criteria	1. The patient has possible or confirmed second stage T. b. gambiense infection, i.e. presence of parasite in the CSF upon microscopic examination or a WBC count in the CSF of more than 5 mm^-3 2. Active clinically relevant medical conditions that in the Investigator's opinion may jeopardise subject safety or interfere with participation in the study, including but not limited to: significant liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, infection including known Human Immunodeficiency Virus (HIV) infection, Central Nervous System (CNS) trauma or seizure disorders 3. Coma Score of less than nine on the Glasgow Coma Scale
Recruitment start date	15/07/2005
Recruitment end date	15/12/2006

Swiss Tropical Institute

Basel
CH-4002
Switzerland

Immtech Pharmaceuticals, Inc. (USA)
Industry

150 Fairway Drive
Suite 150
Vernon Hills
60061
United States of America

Charity

Bill and Melinda Gates Foundation (USA) - grant ref: 38381

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	16/02/2016		Yes	No

10/06/2016: Publication reference added.