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Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis

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ClinicalTrials.gov Identifier: NCT00330148
Recruitment Status : Terminated
First Posted : May 26, 2006
Last Update Posted : May 26, 2006
Sponsor:
Collaborators:
Médecins Sans Frontières, France
Embassy of France in Uganda
National Sleeping Sickness Control Program, Uganda
Information provided by:
Epicentre

Tracking Information
First Submitted Date  ICMJE May 24, 2006
First Posted Date  ICMJE May 26, 2006
Last Update Posted Date May 26, 2006
Study Start Date  ICMJE March 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2006)
Cure rate
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2006)
  • Adverse events temporally associated with the treatment
  • Major adverse events temporally associated with the treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis
Official Title  ICMJE Clinical Trial Comparing the Therapeutic Combinations Melarsoprol-Nifurtimox, Melarsoprol-Eflornithine and Eflornithine-Nifurtimox in the Treatment of Gambiense Human African Trypanosomiasis in the Meningo-Encephalitic Phase
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 becoming ineffective due to parasite resistance; and eflornithine, with better tolerance but more complicated and expensive to implement in endemic countries. nifurtimox, registered only for Chagas' disease but used off-label since the 1970's in series of cases of HAT, is at present the only other available alternative.

The very limited number of compounds available, the lack of prospects for the development of new products and the emergence of resistance are arguments for the use of therapeutic combinations.

This study evaluates the efficacy and safety of three drug combination therapies: melarsoprol-nifurtimox, melarsoprol-eflornithine and eflornithine-nifurtimox.

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 years) mg/kg/day, 8-hourly for 10 days.

For efficacy assessment, patients are followed-up for 24 months after treatment, with planned clinical and laboratory controls.

The safety assessment includes clinical and hematological adverse events.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Trypanosomiasis, African
Intervention  ICMJE
  • Drug: melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d
  • Drug: melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d
  • Drug: nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d
Study Arms  ICMJE Not Provided
Publications * Legros D, Ollivier G, Gastellu-Etchegorry M, Paquet C, Burri C, Jannin J, Büscher P. Treatment of human African trypanosomiasis--present situation and needs for research and development. Lancet Infect Dis. 2002 Jul;2(7):437-40. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: May 24, 2006)
435
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00330148
Other Study ID Numbers  ICMJE EPICENTRE-BTT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Epicentre
Collaborators  ICMJE
  • Médecins Sans Frontières, France
  • Embassy of France in Uganda
  • National Sleeping Sickness Control Program, Uganda
Investigators  ICMJE
Principal Investigator: Gerardo Priotto, MD, MPH Epicentre
PRS Account Epicentre
Verification Date May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP