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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:
ClinicalTrials.gov Identifier:
NCT00489658
First Posted: June 21, 2007
Last Update Posted: June 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Médecins Sans Frontières France
Information provided by:
Epicentre
  Purpose
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.

Condition Intervention Phase
Trypanosomiasis, African Drug: Eflornithine plus Nifurtimox combination therapy Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Efficacy and Safety of an Eflornithine + Nifurtimox Combination for Treatment of Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda

Resource links provided by NLM:


Further study details as provided by Epicentre:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 31
Study Start Date: October 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489658


Locations
Uganda
Yumbe District Hospital
Yumbe, Yumbe District, Uganda
Sponsors and Collaborators
Epicentre
Médecins Sans Frontières France
Investigators
Principal Investigator: Patrice Piola, MD MSc Epicentre
Study Director: Gerardo Priotto, MD MPH Epicentre
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00489658     History of Changes
Other Study ID Numbers: NECS
First Submitted: June 20, 2007
First Posted: June 21, 2007
Last Update Posted: June 21, 2007
Last Verified: June 2007

Keywords provided by Epicentre:
Human African trypanosomiasis
sleeping sickness
Trypanosoma brucei gambiense
combination
eflornithine
nifurtimox
Human African trypanosomiasis (sleeping sickness) due to Trypanosoma brucei gambiense in the late stage (stage 2 or meningo-encephalitic)

Additional relevant MeSH terms:
Trypanosomiasis
Trypanosomiasis, African
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Eflornithine
Nifurtimox
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Ornithine Decarboxylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action