Human African Trypanosomiasis (HAT) Infections and Infestations Human African Trypanosomiasis (HAT)
Conditions
Interventions
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.
Sponsors
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Eligibility
Sex/Gender
All
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of cases with favourable progress at 6 months, based on clinical state and laboratory status. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Angola
Outcome results
None listed