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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

NCT00906880 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 630

Last updated 2013-05-31

No results posted yet for this study

Summary

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.

Conditions

  • Human African Trypanosomiasis

Interventions

DRUG

Nifurtimox-Eflronithine Combination Treatment (NECT)

co-administration of nifurtimox (10 days, 15 mg/kg/day, p.o. TID) and eflornithine (7 days, 400 mg/kg/day, i.v. BID)

Sponsors & Collaborators

  • Ministry of Public Health, Democratic Republic of the Congo

    collaborator OTHER_GOV

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Johannes Blum, MD · Swiss Tropical & Public Health Institute

  • Victor Kande, MD · PNLTHA-DRC;

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-09-30
Completion
2013-01-31

Countries

  • Republic of the Congo

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00906880 on ClinicalTrials.gov