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

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

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

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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 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.

Condition

Human African Trypanosomiasis

Intervention

Nifurtimox-Eflronithine Combination Treatment (NECT)


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

630

Start Date

April 2009

Completion Date

January 2013

Primary Completion Date

September 2010

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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Johannes Blum, MD, , 

Location Countries

Congo

Location Countries

Congo

Administrative Informations


NCT ID

NCT00906880

Organization ID

HAT0208


Responsible Party

Sponsor

Study Sponsor

Drugs for Neglected Diseases

Collaborators

 Ministry of Public Health, Democratic Republic of the Congo

Study Sponsor

Johannes Blum, MD, Principal Investigator, Swiss Tropical & Public Health Institute


Verification Date

May 2013