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Main
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Note: This record shows only 22 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. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN35617647 |
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Date of registration:
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07/06/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessing three day pentamidine for early stage human African trypanosomiasis (Angola)
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Scientific title:
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Date of first enrolment:
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20/12/2004 |
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Target sample size:
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440 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN35617647 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Angola
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Contacts
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Name:
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Melba
Gomes |
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Address:
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20, Avenue Appia
CH 1211
Geneva -27
Switzerland |
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Telephone:
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Email:
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gomesm@who.int |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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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:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Human African Trypanosomiasis (HAT)
Infections and Infestations
Human African Trypanosomiasis (HAT)
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Intervention(s)
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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.
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Primary Outcome(s)
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Proportion of cases with favourable progress at 6 months, based on clinical state and laboratory status.
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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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)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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