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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)
This study is ongoing, but not recruiting participants.
First Received: May 19, 2009 Last Updated: May 18, 2010 History of Changes

Sponsor: Drugs for Neglected Diseases

Collaborators:
Information provided by:
ClinicalTrials.gov Identifier:
Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLT
Swiss Tropical and Public Health Institute
Drugs for Neglected Diseases
NCT00906880

Purpose
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.

Condition Intervention Phase

Human African Trypanosomiasis Drug: Nifurtimox-Eflronithine Combination Treatment (NECT) Phase IV

Study Type: Interventional

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

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
Resource links provided by NLM:

Drug Information available for: Nifurtimox Eflornithine

U.S. FDA Resources

Further study details as provided by Drugs for Neglected Diseases:

Primary Outcome Measures:

Proportion of patients discharged alive from the hospital or the treatment center
[ Designated as safety issue: Yes ]

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. [ Time Frame: up to 24 months after treatment ] [ Designated as safety issue: Yes ]
Effectiveness: The clinical cure rate (Survival without clinical and/or parasitological signs of
HAT) [ Time Frame: 24 months after treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 620

Study Start Date: April 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome
measure)

Intervention Details:
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)

Eligibility
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906880

Locations

Congo, Bandundu
HGR (General Reference Hospital) Kwamouth
Kwamouth, Bandundu, Congo
HGR (General Reference Hospital) Yasa Bonga
Yasa Bonga, Bandundu, Congo

Congo, East Kasai

CDTC (Centre de Dépistage, Traitement et Contrôle) Katanda
Katanda, East Kasai, 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

Congo
HGR (General Reference Hospital) Bandundu
Bandundu, Congo

Sponsors and Collaborators

Drugs for Neglected Diseases
Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA), DRC
Swiss Tropical and Public Health Institute

Investigators
Principal Investigator: Johannes Blum, MD Swiss Tropical Institute
Principal Investigator: Victor Kande, MD PNLTHA-DRC;

More Information
Additional Information:

Sponsor website

No publications provided

Responsible Party: DNDi ( Nathalie Strub-Wourgaft, Clinical Director )

ClinicalTrials.gov Identifier: NCT00906880 History of Changes
Other Study ID Numbers: HAT0208
Study First Received: May 19, 2009
Last Updated: May 18, 2010
Health Authority: Democratic republic of Congo: Ministry of Health

Keywords provided by Drugs for Neglected Diseases:

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

Additional relevant MeSH terms:

Trypanosomiasis Therapeutic Uses
Trypanosomiasis, African Pharmacologic Actions
Mastigophora Infections Enzyme Inhibitors
Sarcomastigophora Infections Molecular Mechanisms of Pharmacological
Protozoan Infections Action
Parasitic Diseases Trypanocidal Agents
Eflornithine Antiprotozoal Agents
Nifurtimox Antiparasitic Agents
Antineoplastic Agents Anti-Infective Agents
ClinicalTrials.gov processed this record on August 09, 2010

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