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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Human African Trypanosomiasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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nifurtimox (Lampit) eflornithine (Ornidyl)

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No