ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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. )

Sponsors and Collaborators: Epicentre
Medecins Sans Frontieres
Information provided by: Epicentre
ClinicalTrials.gov Identifier: NCT00489658
  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 II
Phase III

ChemIDplus related topics:   Eflornithine    Nifurtimox   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Open Label, Uncontrolled, Single Group Assignment
Official Title:   Efficacy and Safety of an Eflornithine + Nifurtimox Combination for Treatment of Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda

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

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

Locations
Uganda, Yumbe District
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:

Study ID Numbers:   NECS
First Received:   June 20, 2007
Last Updated:   June 20, 2007
ClinicalTrials.gov Identifier:   NCT00489658
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)

Study placed in the following topic categories:
Protozoan Infections
Eflornithine
Trypanosomiasis, African
Trypanosomiasis
Parasitic Diseases
African trypanosomiasis
Nifurtimox

Additional relevant MeSH terms:
Anti-Infective Agents
Trypanocidal Agents
Antiparasitic Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Sarcomastigophora Infections
Mastigophora Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers