Overview

Prophylaxis of Fungal Invasive Infections in Leukemia

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
Summary
- To assess the overall clinical yield - in terms of efficacy and safety endpoints of adding caspofungin as prophylaxis of Invasive Pulmonary Aspergillosis in patients undergoing induction treatment for newly diagnosed acute leukemia - To investigate the prognostic significance of Ptx3 at diagnosis and during the first chemotherapy cycle with respect to the development of IPA
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northern Italy Leukemia Group
Treatments:
Caspofungin
Echinocandins
Criteria
Inclusion Criteria:

- all patients with a diagnosis af acute leukemia who are enrolled in the clinical
protocols of NILG for acute leukemia at diagnosis

- age > 18

- written informed consent

Exclusion Criteria:

- presence of signs or symptoms suspected of invasive fungal infection at enrollment

- history of allergy, hypersensitivity, or any serious reaction to echinocandin

- pregnancy or breast-feeding

- acute hepatitis or moderate/severe hepatic insufficiency of any cause;

- concomitant treatment with any systemic antifungal agent

- recent prior use of caspofungin