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Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis

NCT00146627 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2016-09-29

No results posted yet for this study

Summary

The purpose of this study is to compare the therapeutic combination of I.V. eflornithine + oral nifurtimox to the standard IV eflornithine regimen in terms of therapeutic efficacy and clinical safety, in patients suffering from Trypanosoma brucei gambiense (Tbg) human African trypanosomiasis (HAT) in the meningoencephalitic phase.

Conditions

  • Trypanosomiasis, African

Interventions

DRUG

Eflornithine

DRUG

Nifurtimox

Sponsors & Collaborators

  • Medecins Sans Frontieres, Netherlands

    collaborator OTHER

  • PNLTHA-DRC;

    collaborator UNKNOWN

  • PNLTHA-RoC

    collaborator UNKNOWN

  • Epicentre

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • World Health Organization

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Els Torreele, PhD · Drugs for Neglected Diseases

  • Gerardo Priotto, MD, MPH · Epicentre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Democratic Republic of the Congo
  • Republic of the Congo

Study Locations

More Related Trials

Entities

Companies

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 NCT00146627 on ClinicalTrials.gov