Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates the safety and tolerability as well as the efficacy and pharmacokinetics of caspofungin in four escalating dosages in adult patients with hematologic malignancies and proven or probable invasive aspergillosis.

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

Details

• Lead Sponsor: University of Cologne
• Treatments: Caspofungin; Echinocandins

Criteria

Inclusion Criteria:

• Immunocompromised due to hematologic malignancies, bone marrow failure syndromes, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy, treatment with other immunosuppressive medications, or other immunocompromising conditions that place patients at risk for invasive fungal infections.

• Evidence of proven or probable invasive aspergillosis, by modified EORTC criteria

Exclusion Criteria:

• Concomitant other systemic antifungal agents are not permitted on study.

• Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study

• Prior systemic therapy of ≥ 4 days with any polyene anti-fungal agent within 14 days of study enrollment

• Prior systemic therapy of ≥ 4 days with non-polyenes for the current, documented IFI.