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.
Sponsor:
Drugs for Neglected Diseases
Collaborators:
Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA), DRC
Swiss Tropical and Public Health Institute
Information provided by (Responsible Party):
Drugs for Neglected Diseases
ClinicalTrials.gov Identifier:
NCT00906880
First received: May 19, 2009
Last updated: February 10, 2012
Last verified: February 2012
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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 |
| Estimated Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Nifurtimox-Eflronithine Combination Treatment (NECT)
- nifurtimox (Lampit)
- eflornithine (Ornidyl)
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:
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 | |
| 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
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 & Public Health Institute |
| Principal Investigator: | Victor Kande, MD | PNLTHA-DRC; |
More Information
Additional Information:
No publications provided by Drugs for Neglected Diseases
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | February 10, 2012 |
| 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 Eflornithine Nifurtimox Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013