Clinical Study to Assess the Tolerability, Feasibility and Effectiveness of Nifurtimox and Eflornithine (NECT) for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Phase (NECT-FIELD)

May 30, 2013 updated by: Drugs for Neglected Diseases

Clinical Study to Assess the Clinical Tolerability, Feasibility and Effectiveness Under Field Conditions of the Combination of Nifurtimox and Eflornithine (NECT) for the Treatment of T.b.Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Stage

Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase.

Overall objectives:

Assess the clinical tolerability, feasibility and effectiveness of NECT co-administration to treat patients with T.b. gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase in actual real-life conditions (regular treatment centers of the National HAT Control Programme, NGO treatment centers).

Primary objective:

  • Assess the clinical response of the NECT co-administration under field conditions.

Secondary objectives:

  • Assess the incidence and type of adverse events (AE), and the capacity of the treatment centers to deal with these.
  • Assess the feasibility of the implementation of the NECT coadministration by the health center.
  • Assess the effectiveness of the NECT co-administration at 24* months after treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

630

Phase

  • Phase 4

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

  • Congo
      • Bandundu, Congo
        • HGR (General Reference Hospital) Bandundu
    • Bandundu
      • Kwamouth, Bandundu, Congo
        • HGR (General Reference Hospital) Kwamouth
      • Yasa Bonga, Bandundu, Congo
        • HGR (General Reference Hospital) Yasa Bonga
    • East Kasai
      • Katanda, East Kasai, Congo
        • CDTC (Centre de Dépistage, Traitement et Contrôle) Katanda
      • Mbuji Mayi, East Kasai, Congo
        • CRT (Centre de Réference et de Traitement) Dipumba, Dipumba general hospital
      • Ngandajika, East Kasai, Congo
        • HGR (General Reference Hospital) Ngandajika

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:

All patients diagnosed as stage 2 HAT according to the diagnostic protocols in use at the treatment center (generally, if presence of parasites in blood, lymph node fluid or CSF and an elevated white blood cell count in the CSF, but this can vary from center to center) will be included if a written Informed Consent is given by the patient or a legally acceptable representative if the patient is a minor or unable to communicate.

  • Pregnancy and breastfeeding women: On a case by case basis according to the guidelines of the National HAT Control Programme or the NGO, the Investigator will decide to treat the patient or to defer the treatment. In case of inclusion, the mother-child pairs or the children of lactating mothers will be closely monitored during treatment and follow up.
  • Children under 2 years of age: On a case by case basis, the Investigator will decide to treat an infant with NECT or an alternative treatment (preferably eflornithine). In case of inclusion, these infants will be closely monitored during treatment and follow up like all children less than 12 years of age.

Exclusion Criteria:

  • Unable to take oral medication, and impossibility to use a nasogastric tube.
  • Treatment failure after nifurtimox-eflornithine treatment.
  • Any other condition or reason for which the Investigator (or the responsible treating staff member) judges that another or no HAT treatment is warranted.

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of patients discharged alive from the hospital or the treatment center

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious AE (SAE) and severe AE (CTC score 3 and 4) related to treatment, and overall frequency and nature of AE and need for additional medications to manage these.
Time Frame: up to 24 months after treatment
up to 24 months after treatment
Effectiveness: The clinical cure rate (Survival without clinical and/or parasitological signs of HAT)
Time Frame: 24 months after treatment
24 months after treatment
Number of temporary treatment interruptions, number of premature treatment cessations, length of hospitalization stay (including observation period), treatment compliance (deviation in dosing), and other feasibility indicators.
Time Frame: during the treatment/hospitalisation time
during the treatment/hospitalisation time

Collaborators and Investigators

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

Sponsor

Drugs for Neglected Diseases

Collaborators

Swiss Tropical & Public Health Institute
Ministry of Public Health, Democratic Republic of the Congo

Investigators

  • Principal Investigator: Johannes Blum, MD, Swiss Tropical & Public Health Institute
  • Principal Investigator: Victor Kande, MD, PNLTHA-DRC;

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

Helpful Links

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

April 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

May 31, 2013

Last Update Submitted That Met QC Criteria

May 30, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAT0208

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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