Pharmacokinetic, Safety and Efficacy of Intermittent Application of Caspofungin for Antifungal Prophylaxis

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a pilot phase II, prospective, non-comparative, single center trial aimed to evaluate pharmacokinetic and safety of an intermittent dosing schedule for antifungal prophylaxis in high risk patients.

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

Details

• Lead Sponsor: Werner J. Heinz
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Antifungal Agents; Caspofungin; Echinocandins; Miconazole

Criteria

Inclusion Criteria:

• acute myeloid leukemia or myelodysplastic syndrome and blast crisis or acute lymphatic leukemia

• receiving induction chemotherapy

Exclusion Criteria:

• current or need of systemic antifungal therapy

• history of proven or probable invasive aspergillus infection

• pregnant or breastfeeding women

• weight more than 100 kg

• history of allergy, hypersensitivity or any serious reaction to caspofungin