Study of CANCIDAS in Children types of ungal infections

• Register: EUCTR
• Last refreshed on: 7 April 2015
• Main ID: EUCTR2014-004911-35-Outside-EU/EEA
• Date of registration: 03/04/2015
• Prospective Registration: Yes
• Primary sponsor: Merck & Co., Inc.
• Public title: Study of CANCIDAS in Children types of ungal infections
• Scientific title: A Multicenter, Open-Label, Noncomparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in Children with Documented Candida or Aspergillus Infections - Documented Candida or Aspergillus Infections in Pediatric Patients
• Target sample size: 50
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004911-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany, Israel, Italy, Taiwan, United States

Contacts

• Name: Global Clinical Trials Operations
• Affiliation: Merck & Co., Inc.

• Name: Global Clinical Trials Operations
• Affiliation: Merck & Co., Inc.

Key inclusion & exclusion 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:
Patient is <3 months or =18 years of age (at time of the first dose of study drug administration).
Patient has any of the following abnormal laboratory values: a) International normalization ratio (INR) >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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Candida and Aspergillus infections

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

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: 179463-17-3
Current Sponsor code: MK-0991
Other descriptive name: CASPOFUNGIN ACETATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

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).

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.

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).

Timepoint(s) of evaluation of this end point: 2-87 days

Secondary Outcome(s)

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

Secondary ID(s)

MK-0991-043

Source(s) of Monetary Support

Merck & Co., Inc.