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Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda (NECS)

This study has been terminated.
(Because of unexpectedly reduced disease prevalence in the study area, a pragmatic decision was taken to terminate recruitment in March 2003.)
Sponsor:
Collaborator:
Medecins Sans Frontieres
Information provided by:
Epicentre
ClinicalTrials.gov Identifier:
NCT00489658
First received: June 20, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 20, 2007
June 20, 2007
October 2002
Not Provided
Treatment failure (death within 30 days of inclusion, or later if judged as related to Human African trypanosomiasis; termination of treatment due to adverse events; evidence of infection relapse at or after discharge, up to 24 months post discharge) [ Time Frame: 24 months ]
Same as current
No Changes Posted
  • Occurrence and severity of serious clinically apparent adverse events [ Time Frame: treatment period and up to one month post discharge ]
  • Occurrence and severity of biochemical (ALAT, creatinine, bilirubin) and haematological (abnormal total and differential leukocyte count, haemoglobin) adverse events [ Time Frame: treatment period ]
Same as current
Not Provided
Not Provided
 
Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda
Efficacy and Safety of an Eflornithine + Nifurtimox Combination for Treatment of Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda

This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety. The study's purpose is to evaluate the efficacy and safety of this combination in a larger group of late-stage Human African trypanosomiasis (sleeping sickness) patients.

Not Provided
Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Trypanosomiasis, African
Drug: Eflornithine plus Nifurtimox combination therapy
Not Provided
Priotto G, Fogg C, Balasegaram M, Erphas O, Louga A, Checchi F, Ghabri S, Piola P. Three Drug Combinations for Late-Stage Trypanosoma brucei gambiense Sleeping Sickness: A Randomized Clinical Trial in Uganda. PLoS Clin Trials. 2006 Dec 8;1(8):e39.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
Not Provided
Not Provided

Inclusion Criteria:

  • Stage 2 infection with Trypanosoma brucei gambiense diagnosed within the previous 14 days, as defined by either of the following: (i) Presence of trypanosomes in blood or lymph node fluid and WBC count in CSF > 5 / mm3, or (ii) Presence of trypanosomes in the CSF with any CSF WBC count
  • Residence in the study area
  • Written informed consent (to be obtained from parent/guardian for children under 18 years and patients with impaired cognition)

Exclusion Criteria:

  • Pregnancy or clinical history suggestive thereof
  • Weight < 10 Kg
  • History of any HAT treatment within the previous 24 months
  • Inability to undergo hospitalisation or attend follow-up visits during the 24 months following discharge
  • Severe anemia (Hb< 5g/dl)
  • Active tuberculosis (sputum positive)
  • HIV positive (if patient has been tested and results are known)
  • Severe renal or hepatic failure
  • Bacterial or cryptococcal meningitis
  • Other severe underlying diseases upon admission
  • Refugee status
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT00489658
NECS
No
Not Provided
Epicentre
Medecins Sans Frontieres
Principal Investigator: Patrice Piola, MD MSc Epicentre
Study Director: Gerardo Priotto, MD MPH Epicentre
Epicentre
June 2007

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