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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list