Prophylaxis of invasive fungal infection, including life-threatening aspergillosis and candidiasis, is investigated in the study. Patient with acute myeloid leukemia or acute lymphatic leukemia will be included in the study during or before induction chemo therapy. MedDRA version: 12.1 Level: PT Classification code 10003488 Term: Aspergillosis MedDRA version: 12.1 Level: LLT Classification code 10042941 Term: Systemic fungal infection NOS MedDRA version: 12.1 Level: LLT Classification code 10
Conditions
Interventions
Trade Name: Cancidas
Product Name: Caspofungin
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: CASPOFUNGIN ACETATE
CAS Number: 179463-17-3
Concentration unit
Sponsors
Universitaetsklinikum Wuerzburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with acute myeloid leukemia or myelodysplastic syndrome and blast crisis or acute lymphatic leukemia • The patient is receiving induction chemotherapy, starting within 5 days before and 4 days after enrollment. • The patient has an expected duration of neutropenia (neutrophils =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • The patient received systemic antifungal therapy with liposomal amphotericin B, amphotericin B deoxycholate, caspofungin, anidulafungin, micafungin, voriconazole, itraconazole or posaconazole (oral or I.V. for the azoles) but not fluconazole within 3 days prior to enrollment • The patients had a proven or probable invasive Aspergillus infection within 12 months prior to enrollment. • The patient has a possible aspergillosis, due to the following criteria within 14 days of enrollment: o positive galactomannan (OD> 0.5) in serum twice or more times or at least one time in bronchioalveolar fluid o pulmonary infiltrates in the computer tomography of the chest suspicious for fungal infection (positive halo-, air-crescent sign, nodular). Patients with pulmonary infiltrates on conventional chest x-ray, should undergo further evaluation with a CT scan before enrollment if clinically indicated. • The patient is participating in another trial with an investigational drug during the last 14 days before start of prophylaxis. • The patient has a history of allergy, hypersensitivity or any serious reaction to caspofungin or any echinocandin. • Women, who are pregnant or breastfeeding. • The patient has a positive HIV test or known HIV infection • The patient has a known drug abuse. • The patient’s weight is more than 100 kg • The patient has one or more of the following abnormal laboratory values - Serum total bilirubin > 5 times upper limit of normal - INR > 1.6 (INR > 4.0, if the patient is receiving anticoagulation) - Serum ASAT (SGOT) or ALAT (SGPT) > 5 times upper limit of normal • The patient is receiving hemodialyses for severe renal failure • The patient has a moderate or severe hepatic insufficiency (Child Pugh score >6), acute hepatitis or cirrhosis due to any cause • The patient has a life expectancy below 5 days • The patient is receiving rifampin, cyclosporin A, efavirenz, nevirapine, carbamazepine, phenytoin. • The patient has any concomitant illness which, in the opinion of the investigator, might confuse the results of the study or pose additional risk in administering caspofungin to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 representive subject population.;Secondary Objective: To prove the pharmacological approach of intermittent dosing, blood samples will be analyzed for satisfactory serum concentrations at different time points. The differentiated endpoints of fungal infections and overall effectiveness as well as tolerability and safety of the drug will be examined in a series of secondary objectives.;Primary end point(s): Pharmakocinetic of Caspofungin for intermittent dosing including Cmx, Cmin, AUC. | — |
Countries
Germany
Outcome results
None listed