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 has been completed.
Sponsor:
Collaborators:
Ministry of Public Health, Democratic Republic of the Congo
Swiss Tropical & Public Health Institute
Information provided by (Responsible Party):
Drugs for Neglected Diseases
ClinicalTrials.gov Identifier:
NCT00906880
First received: May 19, 2009
Last updated: May 30, 2013
Last verified: May 2013
  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 4

Study Type: Interventional
Study Design: 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:


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 ]

Enrollment: 630
Study Start Date: April 2009
Study Completion Date: January 2013
Primary Completion Date: September 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)
    Other Names:
    • nifurtimox (Lampit)
    • eflornithine (Ornidyl)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Congo
HGR (General Reference Hospital) Kwamouth
Kwamouth, Bandundu, Congo
HGR (General Reference Hospital) Yasa Bonga
Yasa Bonga, Bandundu, Congo
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
HGR (General Reference Hospital) Bandundu
Bandundu, Congo
Sponsors and Collaborators
Drugs for Neglected Diseases
Ministry of Public Health, Democratic Republic of the Congo
Swiss Tropical & Public Health Institute
Investigators
Principal Investigator: Johannes Blum, MD Swiss Tropical & Public Health Institute
Principal Investigator: Victor Kande, MD PNLTHA-DRC;
  More Information

Additional Information:
Publications:
Responsible Party: Drugs for Neglected Diseases
ClinicalTrials.gov Identifier: NCT00906880     History of Changes
Other Study ID Numbers: HAT0208
Study First Received: May 19, 2009
Last Updated: May 30, 2013
Health Authority: Democratic republic of Congo: Ministry of Health

Keywords provided by Drugs for Neglected Diseases:
Human African Trypanosomiasis
HAT
sleeping sickness
combination treatment
nifurtimox
eflornithine
Human African Trypanosomiasis in the meningo-encephalitic phase (stage 2 HAT)

Additional relevant MeSH terms:
Trypanosomiasis
Trypanosomiasis, African
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Nifurtimox
Eflornithine
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014