Human African Trypanosomiasis (HAT) Infections and Infestations Human African Trypanosomiasis
Conditions
Interventions
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:
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. 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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of cases with favourable evolution at 6 months post-treatment, based on laboratory results. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Uganda
Outcome results
None listed