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
Protocol serial number	289-C-010 (C05-010)
Sponsor	Immtech Pharmaceuticals, Inc. (USA)
Funder	Bill and Melinda Gates Foundation (USA) - grant ref: 38381

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	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 objectives	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
Health condition(s) or problem(s) studied	Human African Trypanosomiasis (HAT) or sleeping sickness
Intervention	The subjects will receive either DB289 or pentamidine treatment according to their randomisation.
Intervention type	Drug
Phase	Phase III
Drug / device / biological / vaccine name(s)	DB289 and pentamidine
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	15/12/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	250
Key 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.
Key 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
Date of first enrolment	15/07/2005
Date of final enrolment	15/12/2006

Swiss Tropical Institute

Basel
CH-4002
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

10/06/2016: Publication reference added.