Human African trypanosomiasis Infections and Infestations African trypanosomiasis
Conditions
Interventions
1. Eflornithine IV 7 days 400 mg/kg/day 12 hourly and nifurtimox orally 10 days 15 mg/kg/day 8 hourly
2. Eflornithine IV 14 days 400 mg/kg/day 6 hourly
The total durat
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. Confirmed second-stage Tb gambiense infection: presence of the parasite in blood, lymph node fluid or cerebrospinal fluid (CSF) and greater than 20 white blood cells/µL in CSF 2. Age 15 years or older, either sex 3. Resident in a radius of 50 km from Omugo Sleeping Sickness Treatment Centre 4. Written informed consent of the patient or of a legally acceptable representative if the patient is a minor (less than 18 years for both genders in Uganda) or unable to communicate
Exclusion criteria
Exclusion criteria: 1. Pregnant woman (systematic testing (urine human chorionic gonadotropin [HCG]) of women of childbearing potential) 2. Treated for late-stage HAT during the last 36 months. Patients previously treated for first-stage (pentamidine) can be included. 3. Unlikely to have access to the treatment centre or be accessible at their place of residence for 18 months after treatment 4. Unable to take oral medication 5. Suffering from conditions other than second stage HAT that seriously limit the chances of survival over 18 months time 6. Severe anaemia (haemoglobin [Hb] less than 5 g/dl) 7. Severe underlying diseases upon admission (e.g. active tuberculosis and/or being treated for TB; bacterial or cryptoccocal meningitis; stages 3 or 4 human immunodeficiency virus [HIV]/acquired immune deficiency syndrome [AIDS] according to the WHO clinical definition) (WHO, 1986) 8. Renal failure based on clinical examination combined with biochemistry. Calculated creatinine clearance less than 20 mL/min (Cockcroft's equation). 8.1. Males: creatinine clearance (mL/min) = (Wt [kg] x 140 - age [years]) ÷ (72 x serum creatinine [mg/dL]) 8.2. Females: 0.85 x the above value 9. Hepatic failure based on clinical examination combined with biochemistry total bilirubin greater than 50 µmol/L, alanine aminotransferase (ALAT)/glutamate pyruvate transaminase [GPT] greater than 70 UI/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cure rate assessed via the number of alive subjects 18 months after treatment without laboratory signs of infection, i.e. absence of trypanosome(s) in the CSF, blood or lymph node fluid and CSF leukocytes count less than 20/µl. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The duration of survival without laboratory signs of infection up to 18 months after treatment 2. Proportion of serious adverse events and of major (grade 3 and 4) adverse events related to the treatment (adverse occurring in each treatment arm) | — |
Countries
Uganda
Outcome results
None listed