Pharmacokinetics (PK) and Safety Evaluation of Daptomycin in Children Ages 3-24 Months With Proven or Suspected Gram-positive Infections or Peri-Operative Subjects Receiving Prophylactic Antibiotics
- Conditions
- Gram Positive Bacterial InfectionTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-002779-64-Outside-EU/EEA
- Lead Sponsor
- Cubist Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 23
- Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care
- Male or female between the ages of 3 months and 24 months, inclusive
- Able to comply with the protocol for the duration of the study
- Clinically stable with no evidence of hemodynamic instability (defined as a requirement for inotropic or vasodilatory support to manage blood pressure) in the
24 hour window prior to first dose, and no history or evidence of renal or hepatic
compromise
- Suspected or diagnosed bacterial infection for which the subject was receiving standard antibiotic therapy; including prophylactic use of antibiotics peri-operatively
- A calculated creatinine clearance rate (CLcr) = 80 ml/min/1.73m2 as determined by the Schwartz equation at Baseline
- Creatine kinase levels less than 2 × upper limit of normal (ULN) at Baseline
- Presence of two patent i.v. lines (or comparable means of venous or arterial access) prior to dosing on Study Day 1. A single i.v. line (or comparable means of venous access) was acceptable for both drug administration and sample collection if reasonable effort to gain a second line was unsuccessful. The line had to be flushed prior to obtaining PK samples. Pharmacokinetic sample could have been obtained from a peri-operatively placed arterial line. Arterial PK samples should have been indicated on the case report form (CRF).
Are the trial subjects under 18? yes
Number of subjects for this age range: 23
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
- Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry
- Known allergy/ hypersensitivity to daptomycin
- History of clinically significant, renal, hepatic, autoimmune disease or primary
immune deficiency
- Subjects with clinically significant abnormal laboratory test results (including ECGs), as determined by Investigator
- Administration of rifampin within 7 days of study drug administration
- Subjects in whom collection of the required blood volume would have put them at risk of hemodynamic disturbance (at the discretion of Investigator)
- Planned administration of intramuscular injection within 12 hours following study drug administration unless approved by the Medical Monitor
- Guillain-Barré or spinal cord injury
- History of or current rhabdomyolysis
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