A Study of Caspofungin, Liposomal Amphotericin B or the Combination of Both for Patients After Stem-Cell Transplantation

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Muenster
• Collaborators: Gilead Sciences; Merck Sharp & Dohme Corp.
• Treatments: Amphotericin B; Caspofungin; Echinocandins; Liposomal amphotericin B

Criteria

Inclusion Criteria:

• 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

• 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