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Clinical Trials/ISRCTN36877262
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.

Registry
who.int
Start Date
December 16, 2005
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Institute of Tropical Medicine (Belgium)

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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