A COMPARATIVE EVALUATION OF THE SAFETY AND EFFICACY OF DAPTOMYCIN VERSUS STANDARD OF CARE IN PEDIATRIC SUBJECTS TWO - SEVENTEEN YEARS OF AGE WITH BACTEREMIA CAUSED BY STAPHYLOCOCCUS AUREUS.

Cubist Pharmaceuticals, Inc.0 sites82 target enrollmentFebruary 26, 2013

Overview

No summary available.

Registry

who.int

Start Date

February 26, 2013

End Date

January 20, 2016

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\. Written parental (or appropriate legal representative) informed consent prior to any study\-related procedure
•not part of normal medical care;
•2\. Written subject assent (as appropriate);
•3\. Male or female between the ages of \> 4 and 17 years of age inclusive, (ages \> 2 years after eDMC approval);
•4\. If female, subject must not be pregnant, nursing, and is either:
•a. Not of childbearing potential, defined as pre\-menarche or surgically sterile due to bilateral tubal
•ligation, bilateral oophorectomy, or hysterectomy; or
•b. If of childbearing potential: either abstaining from sexual intercourse or practicing a barrier method of birth control (e.g., a diaphragm or contraceptive sponge) along with 1 of the following methods: oral or parenteral contraceptives. Subjects must be willing to practice these methods for the duration of the trial and for at least 90 days after last dose of study medication;
•5\. Males are required to practice reliable birth control methods (abstinence, condom or other barrier device) during the conduct of the study and for at least 90 days after last dose of study medication unless sterilized;
•6\. Able to comply with the study procedures and to return for scheduled post\-treatment evaluations;

•1\. Previous systemic antimicrobial therapy effective against S. aureus exceeding 72 hours duration
•administered anytime during the 96 hours prior to the first dose of study drug; Exception: subject is eligible
•if culture data demonstrate in vitro resistance to prior i.v. antibiotic;
•2\. Is anticipated to require non\-study systemic antibiotics that may be potentially effective against S. aureus;
•3\. Has shock or hypotension unresponsive to fluids or vasopressors for \=4 hours;
•4\. Has received an investigational drug or participated in any experimental procedure within 30 days of
•randomization (Investigational use of approved products may be permitted with the approval of the
•Medical Monitor);
•5\. Has a documented history of significant allergy or intolerance to daptomycin;
•6\. Has renal insufficiency (i.e. estimated creatinine clearance rate (CLcr)\<50 mL/min/1\.73m2\);