proven or probable aspergillosis in immunocompromised patients MedDRA version: 8.1 Level: LLT Classification code 10003488 Term: Aspergillosis
Conditions
Interventions
Trade Name: Cancidas
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: caspofungin
CAS Number: 179463-17-3
Other descriptive name: L-000743872
Concentration unit: mg milligram
Sponsors
Universität zu Köln
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults =18 years • 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 (=20 mg Prednisone or equivalent for = 3 weeks), treatment with other immunosuppressive medications, or other immunocompromising conditions that place patients at risk for invasive fungal infections (IFIs). • Evidence of proven or probable invasive aspergillosis, by modified EORTC criteria. • • Female patients of childbearing age must have a negative pregnancy test at study entry and take adequate contraceptive measures throughout the study. • Written informed consent given by the patient or his/her legal guardian prior to enrollment in the study. 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
Exclusion criteria: • Pregnant or breast-feeding female patients. • Patients with the following pathological laboratory findings: o Serum bilirubin > 3x upper limit of the age-adjusted normal range o SGOT or SGPT > 5x the upper limit of the age-adjusted normal range o Alkaline phosphatase > 5x the upper limit of the age-adjusted normal range • Patients who have undergone hematopoietic stem-cell transplantation with clinical or laboratory evidence of active veno-occlusive disease (VOD). VOD is characterized by early elevation of serum transaminases and subsequent persistent elevation of serum bilirubin, tenderness of the liver, increase in body weight, and ascites. • Hemodynamically unstable patients or patients with an expected survival time of 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 (i.e., azole or echinochandin derivatives) for the current, documented IFI. (Prior systemic anti-fungal therapy with azole derivatives for prophylaxis or as empiric therapy for febrile neutropenia is permissible. Fluconazole is permissible.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Endpoints of safety and tolerability are the number of toxicity-related study therapy discontinuations and grade III and IV clinical and laboratory events, as evaluated on the basis of current NCI criteria;Main Objective: Endpoints of safety and tolerability are the number of toxicity-related study therapy discontinuations and grade III and IV clinical and laboratory events, as evaluated on the basis of current NCI criteria;Secondary Objective: • efficacy of caspofungin in four escalating dosages in the treatment of proven or probable invasive aspergillosis • generate pharmacokinetic parameters for each dosage level | — |
Countries
Germany
Outcome results
None listed