Trypanosoma brucei gambiense Human African Trypanosomiasis in second stage Infections and Infestations African trypanosomiasis
Conditions
Interventions
A. Standard melarsoprol as administered in the DRC: 3 series of 3.6 mg/kg/day intravenously (IV) (maximum 180 mg/day) for 3 days with 7-day breaks in between series. Total dose: 32.4 mg/kg.
B. Concis
1.2 mg/kg on day 2
1.8 mg/kg from days 3 to 10
maximum 90 mg/day). Total dose: 16.2 mg/kg.
C. Nifurtimox monotherapy: orally, under nurse supervision, 5 mg/kg every 8 hours for 14 days. Total dose: 210 mg/kg.
D. Low-dose concise, consecutive mel
1.2 mg/kg on day 2) followed by 8 days 7.5 mg/kg nifurtimox every 12 hours combined with melarsoprol 1.2 mg/kg/day. Total melarsoprol dose: 11.4 mg/kg. Total nifurtimox dose: 120 mg/kg.
Sponsors
Institute of Tropical Medicine (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, Older than 15 years 2. Second-stage parasitologically confirmed T. b. gambiense infection 3. Never previously treated for sleeping sickness Second stage disease was defined as: 1° cerebrospinal fluid (CSF) white blood cell (WBC) count >20 /µl and detectable IgM in the CSF; or 2° trypanosomes detected in CSF.
Exclusion criteria
Exclusion criteria: 1. Glasgow coma scale <8 2. Pregnancy 3. Active tuberculosis 4. Positive syphilis serology 5. Bacterial or cryptococcal meningitis 6. Severe anaemia 7. Severe renal or hepatic dysfunction 8. Hemorrhagic CSF 9. Residence beyond 100 km from Bwamanda Hospital
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes were relapse, severe adverse events and death attributed to treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes were frequency of other adverse events | — |
Countries
Congo, Democratic Republic
Outcome results
None listed