Clinical study on alternative treatment of patients with second stage Trypanosoma brucei gambiense sleeping sickness
Completed
- Conditions
- African trypanosomiasisTrypanosoma brucei gambiense Human African Trypanosomiasis in second stageInfections and Infestations
- Registration Number
- ISRCTN36877262
- Lead Sponsor
- Institute of Tropical Medicine (Belgium)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 600
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomes were relapse, severe adverse events and death attributed to treatment.
- Secondary Outcome Measures
Name Time Method Secondary outcomes were frequency of other adverse events