Candida and Aspergillus infections
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-
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient is at least 3 months of age and younger than 18 years of age at time of study drug administration. Clinical evidence of infection must be present at some time within 48 hours prior to enrollment. Inclusion Criteria for Patients With Aspergillus Infections: 1) Patients must meet definitions of proven or probable invasive aspergillosis (as specified in criteria developed by the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Co- Operative Group (EORTC/IFICG) and the National Institute of Allergy and Infectious Diseases - Mycoses Study Group (NIAID-MSG) Inclusion Criteria for Patients With Esophageal Candida Infections, Patients with a diagnosis of esophageal candidiasis based on symptoms, endoscopy and microbiology or histopathology for whom IV therapy is appropriate. Inclusion Criteria for Patients With Invasive Candida Infections, Patient must have at least 1 positive culture of a Candida species from blood or other normally sterile body site, which has been obtained within 4 days of study entry. Are the trial subjects under 18? yes Number of subjects for this age range: 49 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 is 1.6 or, if patient is receiving anticoagulants, INR >4.0. b) Bilirubin >3 times the upper limit of normal for age. c) AST (SGOT) or ALT (SGPT) >5 times the upper limit of normal for age. d) Platelet count <5000/µL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objectives of this study are to evaluate the safety, tolerability, and efficacy of caspofungin therapy, administered as 50 mg/m2 IV once daily (maximum 70 mg/day) following a loading dose of 70 mg/m2 (maximum 70 mg/day) on Day 1, in pediatric patients (3 months through 17 years of age) with invasive aspergillosis (IA) who are refractory to or intolerant of standard therapy or those with invasive or esophageal Candida infections. The specific objectives are: Primary: (1) To report the proportion of pediatric patients treated with caspofungin with one or more drug-related clinical or laboratory adverse experience(s).;Secondary Objective: 1) To report the proportion of patients who discontinue due to a drug-related adverse experience or who have a serious drug-related adverse experience. (2) To report the proportion of children with a favorable efficacy response to caspofungin therapy in each of the different infection types.;Primary end point(s): To report the proportion of pediatric patients treated with caspofungin with one or more drug-related clinical or laboratory adverse experience(s).;Timepoint(s) of evaluation of this end point: 2-87 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To report the proportion of patients who discontinue study therapy due to a drug-related adverse experience or who have a serious drug-related adverse experience. (2) To report the proportion of patients with a favorable efficacy response to caspofungin therapy in each of the different infection types.;Timepoint(s) of evaluation of this end point: 2-87 days | — |
Countries
Germany, Israel, Italy, Taiwan, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck & Co., Inc.
Outcome results
None listed