NCT00906880

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
630

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_4

Geographic Reach
1 country

6 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

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

1.4 years

First QC Date

May 19, 2009

Last Update Submit

May 30, 2013

Conditions

Human African Trypanosomiasis

Keywords

Human African TrypanosomiasisHATsleeping sicknesscombination treatmentnifurtimoxeflornithineHuman African Trypanosomiasis in the meningo-encephalitic phase (stage 2 HAT)

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients discharged alive from the hospital or the treatment center

Secondary Outcomes (3)

  • 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.

    up to 24 months after treatment

  • Effectiveness: The clinical cure rate (Survival without clinical and/or parasitological signs of HAT)

    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.

    during the treatment/hospitalisation time

Interventions

Nifurtimox-Eflronithine Combination Treatment (NECT)DRUG

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

Also known as: nifurtimox (Lampit), eflornithine (Ornidyl)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

HGR (General Reference Hospital) Bandundu

Bandundu, Bandundu, Republic of the Congo

Location

HGR (General Reference Hospital) Kwamouth

Kwamouth, Bandundu, Republic of the Congo

Location

HGR (General Reference Hospital) Yasa Bonga

Yasa Bonga, Bandundu, Republic of the Congo

Location

CDTC (Centre de Dépistage, Traitement et Contrôle) Katanda

Katanda, East Kasai, Republic of the Congo

Location

CRT (Centre de Réference et de Traitement) Dipumba, Dipumba general hospital

Mbuji Mayi, East Kasai, Republic of the Congo

Location

HGR (General Reference Hospital) Ngandajika

Ngandajika, East Kasai, Republic of the Congo

Location

Related Publications (3)

  • Schmid C, Kuemmerle A, Blum J, Ghabri S, Kande V, Mutombo W, Ilunga M, Lumpungu I, Mutanda S, Nganzobo P, Tete D, Mubwa N, Kisala M, Blesson S, Mordt OV. In-hospital safety in field conditions of nifurtimox eflornithine combination therapy (NECT) for T. b. gambiense sleeping sickness. PLoS Negl Trop Dis. 2012;6(11):e1920. doi: 10.1371/journal.pntd.0001920. Epub 2012 Nov 29.

    PMID: 23209861RESULT

  • Kuemmerle A, Schmid C, Bernhard S, Kande V, Mutombo W, Ilunga M, Lumpungu I, Mutanda S, Nganzobo P, Tete DN, Kisala M, Burri C, Blesson S, Valverde Mordt O. Effectiveness of Nifurtimox Eflornithine Combination Therapy (NECT) in T. b. gambiense second stage sleeping sickness patients in the Democratic Republic of Congo: Report from a field study. PLoS Negl Trop Dis. 2021 Nov 8;15(11):e0009903. doi: 10.1371/journal.pntd.0009903. eCollection 2021 Nov.

    PMID: 34748572DERIVED

  • Kuemmerle A, Schmid C, Kande V, Mutombo W, Ilunga M, Lumpungu I, Mutanda S, Nganzobo P, Ngolo D, Kisala M, Valverde Mordt O. Prescription of concomitant medications in patients treated with Nifurtimox Eflornithine Combination Therapy (NECT) for T.b. gambiense second stage sleeping sickness in the Democratic Republic of the Congo. PLoS Negl Trop Dis. 2020 Jan 27;14(1):e0008028. doi: 10.1371/journal.pntd.0008028. eCollection 2020 Jan.

    PMID: 31986140DERIVED

Related Links

MeSH Terms

Conditions

Trypanosomiasis, African

Interventions

NifurtimoxEflornithine

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

NitrofuransNitro CompoundsOrganic ChemicalsThiazinesSulfur CompoundsFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOrnithineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Diamino

Study Officials

  • Johannes Blum, MD

    Swiss Tropical & Public Health Institute

    PRINCIPAL INVESTIGATOR

  • Victor Kande, MD

    PNLTHA-DRC;

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

April 1, 2009

Primary Completion

September 1, 2010

Study Completion

January 1, 2013

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

RE(6)