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.
- Conditions
- Bacteremia caused by Staphylococcus Aureus.MedDRA version: 16.0 Level: LLT Classification code 10054637 Term: Staphylococcal bacteremia System Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2012-003447-29-GR
- Lead Sponsor
- Cubist Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 82
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;
7. Have proven or probable S. aureus bacteremia defined as follows:
Proven
• Proven infections will be considered those with S. aureus identified from at least one blood culture bottle by conventional culture methods or by a rapid diagnostic test obtained within 3 calendar days prior to the first dose of study medication (Day -3, Day –2 or Day –1)
Probable
• Probable infections will be those with a preliminary blood culture result demonstrating Gram-positive cocci in clusters upon Gram stain, suggestive of a staphylococcal infection. If the final blood culture yields coagulase negative staphylococci after the patient is enrolled, only high risk patients with persistent bacteremia documented by multiple cultures taken on separate days or from different sites yielding the same organism can continue on study therapy. Patients at high risk include, but are not limited to, immunocompromised children, cancer patients, or those with a potential source of infection from devices or i.v. catheters that are not intended to be removed.
Are the trial subjects under 18? yes
Number of subjects for this age range: 75
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
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);
7. CPK elevation = 10 X ULN (upper limit of normal) without symptoms or = 5 X ULN with symptoms such as myalgia, muscle stiffness, muscle weakness;
8. Has history of clinically significant (as assessed by the Investigator) muscular disease, nervous system or
seizure disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury; previous uncomplicated febrile seizure allowed;
9. Has history of or current rhabdomyolysis;
10. Has suspected or confirmed S. aureus pneumonia (septic emboli in the lung is not an exclusion if clear evidence of source of infection is other than lungs) empyema, meningitis, osteoarticular infection, or endocarditis;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method