Condition category
Infections and Infestations
Date applied
14/12/2007
Date assigned
14/12/2007
Last edited
14/12/2007
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 Deborah Kioy

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3524
kioyd@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A60914; HAT PDE 06-02

Study information

Scientific title

Acronym

Study hypothesis

Human African Trypanosomiasis (HAT) occurs in two forms, a generally acute form caused by Trypanosoma brucei rhodesiense and a usually chronic form caused by Trypanosoma brucei gambiense. Its epidemiology is dependent upon conducive environmental factors and the interaction between humans, tsetse flies (glossina) and trypanosomes. The control accordingly involves action on the reservoir and the vector; the specifics though differ for the two forms. For the case of T. b. gambiense, the action on the reservoir (mainly the human host) involves case detection (passively or actively) and chemotherapy with antitrypanosomal agents along with supportive treatment. The current treatment of stage I (also called early or haemolymphatic stage) T.b. gambiense HAT consists of 7 - 10 daily intramuscular injections of pentamidine 4 mg/kg.

Pharmacokinetics studies have shown that pentamidine has a large volume of distribution and elimination occurs over weeks via metabolism, thus allowing the drug to remain in the body over long periods. The currently used regimen for pentamidine in sleeping sickness patients was derived before such pharmacokinetic data were available. With regimen of 7 - 10 days pentamidine intramuscular (IM) (4 mg/kg) currently used in stage I sleeping sickness, pentamidine accumulation occurs to a significant degree. Unsurprisingly, systemic side-effects such as hypoglycaemia are reported to be more common after the first week of such therapy The objective of the study is to compare the efficacy of 3 days IM pentamidine with the standard 7 day IM regimen (both at 4 mg/kg/day).

Please note that the pilot study for this trial was held in Angola and was registered under the following details:
Title: Assessing three day pentamidine for early stage human African trypanosomiasis (Angola)
Registration reference: ISRCTN35617647 (see http://www.controlled-trials.com/ISRCTN35617647)

Ethics approval

Ethics approval received from:
1. Ethical Clearance Committee (Uganda) on the 8th December 2006 (ref: VCD/UNCT 08 12 06)
2. World Health Organization (WHO) Ethics Review Committee (ERC) on the 18th July 2007 (ref: A60914)

Study design

Non-inferiority clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Human African Trypanosomiasis (HAT)

Intervention

1. Three days pentamidine IM at a dose of 4 mg/kg/day
2. Seven days pentamidine IM at a dose of 4 mg/kg/day

Contact details for Principal Investigator:
Dr Jimmy Opigo
District Directorate of Health Services
Moyo District Local Government
P.O. Box 1
Moyo, Uganda
Tel: +256 (0)37 2273721
Moblie: +256 (0)77 2962601
Email: opigojimmy@gmail.com

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Proportion of cases with favourable evolution at 6 months post-treatment, based on laboratory results.

Secondary outcome measures

1. Proportion of cases with favourable evolution at the end of treatment assessment (day 10), 3 and 12 months post-treatment, based on laboratory results
2. Cure rate at 18 months post-treatment, based on laboratory results
3. Frequency and severity of adverse events

Overall trial start date

01/12/2007

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age greater than or equal to 10 years and less than 60 years
2. Trypanosome positive lymph node aspirate or blood
3. Consenting patient
4. Alternative diagnoses excluded by appropriate clinical and laboratory investigations

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

440

Participant exclusion criteria

1. Abnormal Cerebrospinal Fluid (CSF):
1.1. CSF White Blood Cell [WBC] count greater than 5 WBC/µl
1.2. Presence of trypanosomes
1.3. Haemorrhagic CSF
2. Pregnant
3. Previous HAT treatment
4. Known allergy or reaction to pentamidine
5. Diabetes mellitus
6. Severe difficulty expected with follow-up. Follow-up is difficult for all patients; only if it appears very probable that a patient will not be able to present for follow-up examinations until 18 months post-treatment should he/she be excluded (e.g. Sudanese refugees who have enrolled in the ongoing voluntary repatriation programme)
7. Patients with severe chronic conditions for whom the chance of survival until the end of the 18 months follow-up period is doubtful (e.g. clinical Human Immunodeficiency Virus [HIV]/Acquired Immune Deficiency Syndrome [AIDS] stage IV and Tuberculosis)

Recruitment start date

01/12/2007

Recruitment end date

30/06/2011

Locations

Countries of recruitment

Uganda

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Sponsor details

20
Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3524
tdr@who.int

Sponsor type

Research organisation

Website

http://who.int/tdr

Funders

Funder type

Research organisation

Funder name

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

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

Publication citations

Additional files

Editorial Notes