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

June 20, 2007 updated by: Epicentre

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
    • Yumbe District
      • Yumbe, Yumbe District, Uganda
        • Yumbe District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence and severity of serious clinically apparent adverse events
Time Frame: treatment period and up to one month post discharge
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
treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epicentre

Collaborators

Médecins Sans Frontières, France

Investigators

  • Principal Investigator: Patrice Piola, MD MSc, Epicentre
  • Study Director: Gerardo Priotto, MD MPH, Epicentre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

June 21, 2007

Last Update Submitted That Met QC Criteria

June 20, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NECS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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