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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 (NECT-FIELD)

Primary Purpose

Human African Trypanosomiasis

Status

Completed

Phase

Phase 4

Locations

Congo

Study Type

Interventional

Intervention

Nifurtimox-Eflronithine Combination Treatment (NECT)

About this trial

This is an interventional treatment trial for Human African Trypanosomiasis focused on measuring Human African Trypanosomiasis, HAT, sleeping sickness, combination treatment, nifurtimox, eflornithine, Human African Trypanosomiasis in the meningo-encephalitic phase (stage 2 HAT)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

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.

Full Information

NCT ID

NCT00906880

First Posted

May 19, 2009

Last Updated

May 30, 2013

Sponsor

Drugs for Neglected Diseases

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00906880

Brief Title

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

Acronym

NECT-FIELD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Drugs for Neglected Diseases

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human African Trypanosomiasis

Keywords

Human African Trypanosomiasis, HAT, sleeping sickness, combination treatment, nifurtimox, eflornithine, Human African Trypanosomiasis in the meningo-encephalitic phase (stage 2 HAT)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

630 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nifurtimox-Eflronithine Combination Treatment (NECT)

Other Intervention Name(s)

nifurtimox (Lampit), eflornithine (Ornidyl)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Time Frame

24 months after treatment

Title

Time Frame

during the treatment/hospitalisation time

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johannes Blum, MD

Organizational Affiliation

Swiss Tropical & Public Health Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Victor Kande, MD

Organizational Affiliation

PNLTHA-DRC;

Official's Role

Principal Investigator

Facility Information:

Facility Name

HGR (General Reference Hospital) Kwamouth

City

Kwamouth

State/Province

Bandundu

Country

Congo

Facility Name

HGR (General Reference Hospital) Yasa Bonga

City

Yasa Bonga

State/Province

Bandundu

Country

Congo

Facility Name

CDTC (Centre de Dépistage, Traitement et Contrôle) Katanda

City

Katanda

State/Province

East Kasai

Country

Congo

Facility Name

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

City

Mbuji Mayi

State/Province

East Kasai

Country

Congo

Facility Name

HGR (General Reference Hospital) Ngandajika

City

Ngandajika

State/Province

East Kasai

Country

Congo

Facility Name

HGR (General Reference Hospital) Bandundu

City

Bandundu

Country

Congo

12. IPD Sharing Statement

Citations:

PubMed Identifier

23209861

Citation

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.

Results Reference

result

PubMed Identifier

34748572

Citation

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.

Results Reference

derived

PubMed Identifier

31986140

Citation

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.

Results Reference

derived

Links:

URL

http://www.dndi.org/

Description

Sponsor website

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