Status:
COMPLETED
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
Lead Sponsor:
Drugs for Neglected Diseases
Collaborating Sponsors:
Ministry of Public Health, Democratic Republic of the Congo
Swiss Tropical & Public Health Institute
Conditions:
Human African Trypanosomiasis
Eligibility:
All Genders
Phase:
PHASE4
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 trypa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00906880
Start Date
April 1 2009
End Date
January 1 2013
Last Update
May 31 2013
Active Locations (6)
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1
HGR (General Reference Hospital) Bandundu
Bandundu, Bandundu, Republic of the Congo
2
HGR (General Reference Hospital) Kwamouth
Kwamouth, Bandundu, Republic of the Congo
3
HGR (General Reference Hospital) Yasa Bonga
Yasa Bonga, Bandundu, Republic of the Congo
4
CDTC (Centre de Dépistage, Traitement et Contrôle) Katanda
Katanda, East Kasai, Republic of the Congo