Description:

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 haematopoietic stem-cell transplantation with granulocytopenia and persistent i.g. recurrent fever under adequate antibacterial therapy.

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  1. 12/11/13
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December 11, 2013

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License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00148148 # Stem-Cell Transplantation

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
18 Years and older
Male
No Healthy Volunteers
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 criteria
Patients with active, possible or proven (MSG-EORTC criteria) invasive fungal infection at time of enrollment
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
Medical Concepts