KW-Inf-001: Prospective trial to evaluate pharmacokinetic, safety and efficacy of intermittent application of increased doses of caspofungin for antifungal prophylaxis in high risk patients. - CASPHYLAX

• Conditions: 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: 12.1Level: PTClassification code 10003488Term: Aspergillosis; MedDRA version: 12.1Level: LLTClassification code 10042941Term: Systemic fungal infection NOS; MedDRA version: 12.1Level: LLTClassification code 10007152Term: Candidiasis; MedDRA version: 12.1Level: LLTClassification code 10036898Term: Prophylaxis

• Registration Number: EUCTR2009-015159-26-DE
• Lead Sponsor: niversitaetsklinikum Wuerzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-18
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

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 < 500/µl) for
at least 10 days
• The patient has no proven or probable invasive Aspergillus infection within
12 months prior to enrollment
• For women with childbearing potential, the patient has a negative serum or
urine pregnancy test within 48 hours of enrollment and the patient agrees to
use adequate birth control measures as defined by the investigator. Oral
contraceptives should not be used as the sole method of birth control.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified