Status:
COMPLETED
A Study of Caspofungin, Liposomal Amphotericin B or the Combination of Both for Patients After Stem-Cell Transplantation
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Gilead Sciences
Conditions:
Hematopoietic Stem Cell Transplantation
Fungus Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study compares the safety, efficacy and pharmacokinetics of caspofungin, liposomal amphotericin B or the combination of both in the antifungal treatment of adult patients after allogeneic haematop...
Detailed Description
This is an open, randomised, three-arm multicenter phase II clinical trial investigating the safety, tolerance and plasma pharmacokinetics of caspofungin, liposomal amphotericin B and the combination ...
Eligibility Criteria
Inclusion
- Adults (\> or = 18 years of age) with granulocytopenia (absolute number of neutrophil granulocytes \[ANC\]: \< or = 500/µL) who have undergone allogeneic haematopoeitic stem cell transplantation and immunosuppression with cyclosporin A
- Patients with persistent or recurrent fever (oral temperature \> or = 38.0°C) and granulocytopenia (absolute neutrophil count \< or = 500/µL) and adequate antibacterial therapy for \> or = 36-48 hours, who need empirical antimycotic therapy
- Already inserted at least double-lumen central venous catheter for administration of drugs and extraction of plasma samples
- Sufficient renal and hepatic function
- Availability of negative pregnancy test and adequate contraceptive measures for female patients of childbearing age
- Availability of written informed consent from the patient or respectively from the legal representative after prior information
Exclusion
- Patients with active, possible or proven (MSG-EORTC criteria) invasive fungal infection at time of enrollment
- Pregnant or nursing patients
- Patients with pathological functional renal or hepatic parameters
- Patients with clinical or laboratory chemical evidence of active veno-occlusive disease (VOD)
- Hemodynamically unstable patients with a life expectancy of less than 5 days
- Patients undergoing co-medication with rifampicin, phenytoin, carbamazepine, phenobarbital, dexamethasone, efavirenz and nevirapine
- Patients with prior known serious reaction to echinocandin-antifungal formulation or documented allergy to amphotericin B
- Patients with other condition or illness which, in the estimation of the investigator, distorts the study results or leads to an additional risk for the patient
- Prior inclusion in the study
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00148148
Start Date
May 1 2004
End Date
December 1 2007
Last Update
January 16 2008
Active Locations (1)
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1
KKS Münster University Hospital
Münster, North Rhine-Westphalia, Germany, 48145