Status:
TERMINATED
Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis
Lead Sponsor:
Epicentre
Collaborating Sponsors:
Médecins Sans Frontières, France
Embassy of France in Uganda
Conditions:
Trypanosomiasis, African
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The treatment human African trypanosomiasis (HAT) in the meningoencephalitic phase relies on two molecules officially registered: melarsoprol, the most commonly used, has a poor safety profile and is ...
Detailed Description
Dosages per drug are the same in either arm of the study: IV melarsoprol 1.8 mg/kg/day, daily for 10 days; IV eflornithine 400 mg/kg/day, 6-hourly for 7 days; oral nifurtimox 15 or 20 (children \<15 y...
Eligibility Criteria
Inclusion
- confirmed second-stage T.b. gambiense infection :
- Infection diagnosed parasitologically (blood or lymph node fluid) and white blood cells \> 5/mm3 in cerebrospinal fluid (CSF)
- or Trypanosomes detected in the CSF with any CSF cell count
- and resident in the district
- and written consent of the patient or of one of the parents/guardians for children under 15 years of age.
Exclusion
- Trypanosome absent from blood (or lymph node fluid) and from CSF
- Or women pregnant on inclusion
- Or previous history of HAT confirmed treated during the last 24 months
- Or impossibility of regular access to the treatment centre during the 2 years following the end of the treatment
- Or less than 10 kg of body weight
- Or refugee patient
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
End Date :
June 1 2004
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT00330148
Start Date
March 1 2001
End Date
June 1 2004
Last Update
May 26 2006
Active Locations (1)
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1
Omugo Sleeping Sickness Treatment Center
Omugo, Arua District, Uganda