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:
Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA), DRC
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

May 19, 2009
May 30, 2013
April 2009
September 2010   (final data collection date for primary outcome measure)
Proportion of patients discharged alive from the hospital or the treatment center [ Designated as safety issue: Yes ]
Proportion of patients discharged alive from the hospital (treatment center) [ Time Frame: 30 days after start of treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00906880 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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) at 24 months. [ Time Frame: 24 months after treatment ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
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
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

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.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Human African Trypanosomiasis
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)
Not Provided
Schmid C, Kuemmerle A, Blum J, Ghabri S, Kande V, Mutombo W, Ilunga M, Lumpungu I, Mutanda S, Nganzobo P, Tete D, Mubwa N, Kisala M, Blesson S, Mordt OV. In-hospital safety in field conditions of nifurtimox eflornithine combination therapy (NECT) for T. b. gambiense sleeping sickness. PLoS Negl Trop Dis. 2012 Nov;6(11):e1920. doi: 10.1371/journal.pntd.0001920. Epub 2012 Nov 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
630
January 2013
September 2010   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Congo
 
NCT00906880
HAT0208
Yes
Drugs for Neglected Diseases
Drugs for Neglected Diseases
  • Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA), DRC
  • Swiss Tropical & Public Health Institute
Principal Investigator: Johannes Blum, MD Swiss Tropical & Public Health Institute
Principal Investigator: Victor Kande, MD PNLTHA-DRC;
Drugs for Neglected Diseases
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP