Fungal Infection Clinical Trial
— CASPHYLAXOfficial title:
Prospective Trial to Evaluate Pharmacokinetic, Safety and Efficacy of Intermittent Application of Increased Doses of Caspofungin for Antifungal Prophylaxis in High Risk Patients
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | October 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | University of Wuerzburg Medical Centre, Department of Internal Medicine II | Wuerzburg |
Lead Sponsor | Collaborator |
---|---|
Werner J. Heinz | Merck Sharp & Dohme Corp. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | caspofungin pharmacokinetic | To characterize the pharmacokinetic of caspofungin IV solution in an intermittent dosing schedule of 3 times a week after a 3 days loading in a representative subject population. | day 20 (average), till end of enutropenia | No |
Secondary | Caspofungin pharmacokinetic | caspofungin serum concentrations | day 20 (average), at end of neutropenia | No |
Secondary | Incidence of invasive fungal disease and outcome | Incidence of proven or probable invasive fungal disease according to the revised EORTC/MSG criteria during the period of prophylaxis and during follow up. | day 100 after start of chemotherapy | No |
Secondary | Safety of intermittent caspofungin | Caspofungin related and all adverse and serious adverse events | day 34 (average), 2 weeks after end of neutropenia | Yes |
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