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NCT Number: NCT00906880

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

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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Key information

Conditions

Human African Trypanosomiasis Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Trypanosomiasis, African Vector Borne Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HGR (General Reference Hospital) Bandundu, Bandundu, Republic of the Congo

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: nifurtimox (Lampit), eflornithine (Ornidyl)

Primary outcomes

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

Secondary outcomes

  1. 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

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

    Time frame: 24 months after treatment

  3. 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.

    Time frame: during the treatment/hospitalisation time

Sponsors and collaborators

Lead sponsor

Drugs for Neglected Diseases

Other

Collaborators

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

Registry information

Official study 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

Acronym: NECT-FIELD

Important dates

Study start
2009
Primary completion
2010
Study completion
2013
First posted
May 21, 2009
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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