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

Human African Trypanosomiasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906880
• Other study ID #: HAT0208
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2009
• Last updated: May 30, 2013
• Start date: April 2009
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Drugs for Neglected Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: Democratic republic of Congo: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: January 2013
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Human African Trypanosomiasis
• Trypanosomiasis
• Trypanosomiasis, African

Intervention

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)

Locations

Country	Name	City	State
Congo	HGR (General Reference Hospital) Bandundu	Bandundu
Congo	CDTC (Centre de Dépistage, Traitement et Contrôle) Katanda	Katanda	East Kasai
Congo	HGR (General Reference Hospital) Kwamouth	Kwamouth	Bandundu
Congo	CRT (Centre de Réference et de Traitement) Dipumba, Dipumba general hospital	Mbuji Mayi	East Kasai
Congo	HGR (General Reference Hospital) Ngandajika	Ngandajika	East Kasai
Congo	HGR (General Reference Hospital) Yasa Bonga	Yasa Bonga	Bandundu

Sponsors (3)

Lead Sponsor	Collaborator
Drugs for Neglected Diseases	Ministry of Public Health, Democratic Republic of the Congo, Swiss Tropical & Public Health Institute

Country where clinical trial is conducted

Congo, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients discharged alive from the hospital or the treatment center			Yes
Secondary	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	Yes
Secondary	Effectiveness: The clinical cure rate (Survival without clinical and/or parasitological signs of HAT)		24 months after treatment	No
Secondary	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	Yes

External Links

•   Sponsor website