ISRCTN36877262
Completed
Not Applicable
Clinical study on alternative treatment of patients with second stage Trypanosoma brucei gambiense sleeping sickness
Institute of Tropical Medicine (Belgium)0 sites600 target enrollmentDecember 16, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trypanosoma brucei gambiense Human African Trypanosomiasis in second stage
- Sponsor
- Institute of Tropical Medicine (Belgium)
- Enrollment
- 600
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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