Condition category
Infections and Infestations
Date applied
12/07/2005
Date assigned
23/08/2005
Last edited
10/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christian Burri

ORCID ID

Contact details

Swiss Tropical Institute
Socinstrasse 57
Basel
CH-4002
Switzerland
+41 61 225 26 61
Christian.Burri@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

289-C-010 (C05-010)

Study information

Scientific title

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

Acronym

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Phase III

Drug names

DB289 and pentamidine

Primary outcome measures

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 trial start date

15/07/2005

Overall trial end date

15/12/2006

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

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

Locations

Countries of recruitment

Angola, Congo, Sudan

Trial participating centre

Swiss Tropical Institute
Basel
CH-4002
Switzerland

Sponsor information

Organisation

Immtech Pharmaceuticals, Inc. (USA)

Sponsor details

150 Fairway Drive
Suite 150
Vernon Hills
60061
United States of America
+1 847 573 0033
colson@immtechpharma.com

Sponsor type

Industry

Website

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26882015

Publication citations

Additional files

Editorial Notes

10/06/2016: Publication reference added.