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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 14 July 2014
Main ID:  ISRCTN35617647
Date of registration: 07/06/2005
Primary sponsor: UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Public title: Assessing three day pentamidine for early stage human African trypanosomiasis (Angola) N/A
Scientific title:
Date of first enrolment: Dec 20 2004
Target sample size: The total target was 440 patients, but only 18 were recruited in this site.
Recruitment status: Completed/Not recruiting
Study type:  Interventional
Study design:  Randomised controlled trial  
Countries of recruitment
Name: Melba  Gomes
Address:  20, Avenue Appia CH 1211 Geneva -27 Switzerland
Key inclusion & exclusion criteria
Inclusion criteria: 1. Aged more than or equal to 14 years and less than 60 years
2. Parasite positive (on examination of lymph juice, by Capillary Tube Centrifugation [CTC] or miniature Anion-Exchange Centrifugation [mAEC] on whole blood)
3. Alternative diagnoses excluded clinically and by appropriate laboratory investigations
4. Capable of and giving informed consent to the study

Exclusion criteria: 1. Stage II Human African Trypanosomiasis (HAT): defined as parasites in cerebrospinal fluid (CSF), or having more than or equal to 6 cells/mm^3 in CSF; or more than 100 red cells/mm^3 ("bloody tap")
2. Pregnant
3. Previous HAT
4. Known allergy or reactions to pentamidine
5. Diabetes mellitus
6. Difficulty to comply with follow-up (patients of no fixed abode and refugees, for example)

Age minimum:
Age maximum:
Health Condition(s) or Problem(s) studied
Human African Trypanosomiasis (HAT)
This will be an open, randomised comparison of two pentamidine treatment regimens, given over three days or seven days with a non-inferiority trial design.
Primary Outcome(s)
Proportion of cases with favourable progress at 6 months, based on clinical state and laboratory status.
Secondary Outcome(s)
1. Proportion of cases with favourable progress at discharge, 3 and 12 months based on clinical state and laboratory status
2. Cure rate at 18 months, based on based on clinical state and laboratory status
3. Frequency and severity of adverse events
Secondary ID(s)
Source(s) of Monetary Support
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)
Secondary Sponsor(s)
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