PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00679835
First received: May 15, 2008
Last updated: September 20, 2010
Last verified: September 2010

May 15, 2008
September 20, 2010
May 2008
November 2008   (final data collection date for primary outcome measure)
Pharmocokinetics of daptomycin [ Time Frame: From pre-dose to 24 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00679835 on ClinicalTrials.gov Archive Site
Safety of daptomycin [ Time Frame: Up to 9 days after dosing ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged Two to Six Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection

This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a specific group of bacteria (called Gram-positive bacteria).

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Gram Positive Infection
  • Concurrent Antibiotic Treatment
Drug: daptomycin
i.v. daptomycin given at 8 mg/kg or 10 mg/kg by a one or two hour infusion.
Other Name: Cubicin
  • Experimental: Group 1
    8 mg/kg over a one hour infusion
    Intervention: Drug: daptomycin
  • Experimental: Group 2
    10mg/kg over a one or two hour infusion
    Intervention: Drug: daptomycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 2 and 6 years old, 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 pharmacological intervention to manage blood pressure) in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise;
  • Suspected or diagnosed Gram-positive infection for which the subject is receiving standard antibiotic therapy;
  • A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline;
  • Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline.
  • Presence of two patent intravenous lines (or comparable means of venous access) prior to dosing on Study Day 1.

Exclusion Criteria:

  • 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 cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency;
  • Pneumonia as sole Gram-positive infection being treated with standard antibiotics;
  • Subjects with clinically significant abnormal laboratory test results [including electrocardiograms (ECGs)], as determined by Investigator;
  • Administration of rifampin within 7 days of study drug administration;
  • Body mass index (BMI) that is outside of the 5th to 95th percentile;
  • Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator);
  • History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder;
  • Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection within 24 hours following dosing;
  • Expected surgical procedure(s) within 24 hours prior to and following dosing;
  • Unexplained muscular weakness, history of peripheral neuropathy, Guillian-Barre or spinal cord injury;
  • History of or current rhabdomyolysis.
Both
2 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00679835
DAP-PEDS-07-02
No
Ed Campanaro, Cubist Pharmaceuticals Inc
Cubist Pharmaceuticals
Not Provided
Not Provided
Cubist Pharmaceuticals
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP