NCT00146627

Brief 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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2009

First QC Date

September 6, 2005

Last Update Submit

September 28, 2016

Conditions

Trypanosomiasis, African

Keywords

Human African TrypanosomiasisCombinationTrypanosoma brucei gambiense Human African Trypanosomiasis

Interventions

EflornithineDRUG
NifurtimoxDRUG

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed second-stage T.b. gambiense infection : presence of the parasite in blood, lymph node fluid or CSF and \>20 white blood cells/µL in CSF. In presence of blood in the CSF, lumbar puncture must be done again or the patient cannot be included in the study (see 10.9.1).
  • and of age 15 years or older.
  • and resident in \_\_\_\_\_\_\_\_\_\_ (each site will define boundaries or maximum distance)
  • and written informed consent of the patient or of a legally acceptable representative if the patient is a minor (\<18 years for both genders in Uganda and Angola, \<18 years for males and \<16 years for females in the Democratic Republic of Congo) or unable to communicate.

You may not qualify if:

  • pregnant woman (systematic testing of women of childbearing potential)
  • treated for late-stage HAT during the last 36 months. Patients previously treated for first-stage (pentamidine) can be included.
  • unlikely to have access to the treatment centre or be accessible at their place of residence for 18 months after treatment
  • unable to take oral medication
  • suffering from conditions other than second stage HAT that seriously limit the chances of survival over 18 months time
  • Severe anemia (Hb\< 5g/dl)
  • Severe underlying diseases upon admission (e.g. Active tuberculosis and/or being treated for TB; Bacterial or cryptococcal meningitis; Stages 3 or 4 HIV/AIDS according to the WHO clinical definition) (WHO, 1986).
  • Severe renal failure based on clinical examination combined with biochemistry if available: creatinine clearance \<20mL/min
  • Severe hepatic failure based on clinical examination combined with biochemistry if available: total bilirubin \>50 µmol/L, ALAT/GPT \>70 UI/L, unless these laboratory values are determined by the investigator as likely due to conditions other than hepatic failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

MSF-Belgium; PNLTHA, Epicentre

Isangi, Democratic Republic of the Congo

Location

PNLTHA, STI, Epicentre

Katanda, Democratic Republic of the Congo

Location

PNLTHA, STI, Epicentre

Mbuyi Maji, Democratic Republic of the Congo

Location

MSF-Holland

Nkayi, RoC, Republic of the Congo

Location

Related Publications (2)

  • Opigo J, Woodrow C. NECT trial: more than a small victory over sleeping sickness. Lancet. 2009 Jul 4;374(9683):7-9. doi: 10.1016/S0140-6736(09)61163-6. Epub 2009 Jun 24. No abstract available.

    PMID: 19559477BACKGROUND

  • Priotto G, Kasparian S, Mutombo W, Ngouama D, Ghorashian S, Arnold U, Ghabri S, Baudin E, Buard V, Kazadi-Kyanza S, Ilunga M, Mutangala W, Pohlig G, Schmid C, Karunakara U, Torreele E, Kande V. Nifurtimox-eflornithine combination therapy for second-stage African Trypanosoma brucei gambiense trypanosomiasis: a multicentre, randomised, phase III, non-inferiority trial. Lancet. 2009 Jul 4;374(9683):56-64. doi: 10.1016/S0140-6736(09)61117-X. Epub 2009 Jun 24.

    PMID: 19559476RESULT

Related Links

MeSH Terms

Conditions

Trypanosomiasis, African

Interventions

EflornithineNifurtimox

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

OrnithineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoNitrofuransNitro CompoundsOrganic ChemicalsThiazinesSulfur CompoundsFuransHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Els Torreele, PhD

    Drugs for Neglected Diseases

    STUDY CHAIR

  • Gerardo Priotto, MD, MPH

    Epicentre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 29, 2016

Record last verified: 2009-09

Locations

RE(1)DE(3)