Candida or Aspergillus Infections
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female Japanese patient between the ages of 3 months and 17 years at the time when informed consent was obtained. • Patients in whom a causative fungus was detected before treatment with the study drug or patients with strongly suspected Candida or Aspergillus infections, as defined below for esophageal candidiasis, invasive candidiasis (candidemia or other types of invasive candidiasis), and aspergillosis (invasive aspergillosis, chronic necrotizing pulmonary aspergillosis, or pulmonary aspergilloma). Are the trial subjects under 18? yes Number of subjects for this age range: 20 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: • Patients with mycoses (e.g., Cryptococcus spp., Trichosporon spp., or zygomycetes including Mucor spp.) other than ones due to Candida spp. or Aspergillus spp. • Patients who will receive other systemic antifungal agents (indicated for deep-seated fungal infections) for the first time in the screening period. • At screening, patients with any of the laboratory abnormalities listed below: (1) Total bilirubin: More than 5 times the upper limit of the normal range (>5 ULN), (2) AST (SGOT) or ALT (SGPT): More than 5 times the upper limit of the normal range (>5 ULN)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of caspofungin in Japanese pediatric patients.;Secondary Objective: (1) To evaluate the proportion of Japanese pediatric patients with a favorable efficacy response (based on overall response) to caspofungin therapy in each of the different infection types (invasive candidiasis, esophageal candidiasis, and aspergillosis). (2)To evaluate caspofungin plasma concentration profiles and pharmacokinetic parameters obtained in Japanese pediatric patients.;Primary end point(s): Evaluate the safety and tolerability of caspofungin in Japanese pediatric patients.;Timepoint(s) of evaluation of this end point: 7-84 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate the proportion of Japanese pediatric patients with a favorable efficacy response to caspofungin therapy in each of the different infection types;Timepoint(s) of evaluation of this end point: 7-84 days | — |
Countries
Japan
Contacts
Public ContactGlobal Clinical Trials Operations (
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed