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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
  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: 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489658

Locations
Uganda
Yumbe District Hospital
Yumbe, Yumbe District, Uganda
Sponsors and Collaborators
Epicentre
Medecins Sans Frontieres
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
Study First Received: June 20, 2007
Last Updated: June 20, 2007
Health Authority: Uganda: National Council for Science and Technology
Uganda: Ministry of Health

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
Parasitic Diseases
Protozoan Infections
Eflornithine
Nifurtimox
Anti-Infective Agents
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Trypanocidal Agents

ClinicalTrials.gov processed this record on November 25, 2014