Empirical Therapy in Pediatric Patients
Conditions
Interventions
Trade Name: Cancidas ™
Product Name: Cancidas™
Product Code: MK-0991
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Caspofungin acetate
CAS Number: 179463-1
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients are at least 2 years of age and less than 18 years of age at the time of initial screening. • Patient has received chemotherapy for leukemia, lymphoma, or other cancers or has undergone hematopoietic stem-cell transplantation. • Patient has had an absolute neutrophil count 38.0°C within the last 24 hours prior to randomization. Appropriate antibiotics are those that provide broad spectrum Gram-positive and Gramnegative coverage. Are the trial subjects under 18? yes Number of subjects for this age range: 82 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patient has an inadequately managed bacterial infection at the time of enrollment. • Patient has abnormal laboratory values: 1) Platelet count 1.6 (if patients are receiving anticoagulants, INR>4.0). 3) Bilirubin >3 times upper limit of normal for age. 4) AST (SGOT) or ALT (SGPT) >5 times the upper limit of normal for age. • Patient has a known documented invasive fungal infection at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate in pediatric patients, aged 2 to 17 years, with persistent fever and neutropenia, the proportion of patients treated with caspofungin reporting one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period plus 14 days posttherapy.;Secondary Objective: To estimate in pediatric patients (2 to 17 years), who are treated with caspofungin or liposomal amphotericin B for persistent fever and neutropenia: a. The proportion of patients reporting one or more clinical and/or laboratory drug-related serious adverse experience(s) during the study drug therapy period plus 14 days posttherapy. b. The proportion of patients reporting one or more clinical and/or laboratory drug-related adverse experience(s) leading to discontinuation of study therapy. c. The proportion of patients with a favorable overall efficacy outcome.;Primary end point(s): The proportion of patients treated with one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period.;Timepoint(s) of evaluation of this end point: 1-55 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of patients treated with one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period.;Timepoint(s) of evaluation of this end point: 1-55 days | — |
Countries
Germany, Spain, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck & Co., Inc.
Outcome results
None listed