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Study of Single Dose Daptomycin in Pediatric Patients With Gram-Positive Infection for Which They Are Receiving Standard Antibiotics

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00136292
First received: August 25, 2005
Last updated: January 16, 2007
Last verified: January 2007

August 25, 2005
January 16, 2007
Not Provided
Not Provided
Pharmacokinetic
Same as current
Complete list of historical versions of study NCT00136292 on ClinicalTrials.gov Archive Site
Tolerability
Same as current
Not Provided
Not Provided
 
Study of Single Dose Daptomycin in Pediatric Patients With Gram-Positive Infection for Which They Are Receiving Standard Antibiotics
An Evaluation of the Pharmacokinetics of a Single Dose of Daptomycin (4 mg/kg) in Pediatric Patients Aged Two to Seventeen Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-Positive Infection

The purpose of this study is to evaluate the pharmacokinetics of a single dose of daptomycin in patients aged 2-17 years old who have a suspected or proven gram-positive infection for which they are receiving standard antibiotic therapy. The tolerability of a single dose of daptomycin in these patients will also be assessed.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Gram-Positive Bacterial Infections
Drug: daptomycin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
Not Provided

Inclusion Criteria:

  • 2-17 years old
  • Suspected or diagnosed gram-positive infection for which the patient is receiving standard antibiotic therapy
  • Clinically stable with no evidence of hemodynamic instability in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise, or clinically significant alterations in fluid/electrolyte homeostasis
  • Creatinine clearance (CLcr) ≥ 80 ml/min/1.73 m2 as determined by the Schwartz equation
  • Creatine phosphokinase (CPK) levels within normal limits

Exclusion Criteria:

  • Known allergy to daptomycin
  • History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, or autoimmune disease
  • Pneumonia as sole gram-positive infection
  • Use of HMG-CoA reductase inhibitors or other systemic anti-hyperlipidemic agents within 7 days prior to study drug administration and expected use through 3 days post-dose
  • Clinically significant abnormal laboratory test results (including electrocardiograms [ECGs]), as determined by Investigator
  • Body mass index (BMI) that is outside of the 5th to 95th percentile for age
  • History (personal or 1st degree relative) of clinically significant muscular disease, nervous system, seizure or psychiatric disorder
  • Expected intramuscular (IM) injection within 3 days following dosing
  • Expected surgical procedure(s) within 3 days following dosing
  • Unexplained muscular weakness
  • Rhabdomyolysis, myositis or septic shock
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00136292
DAP-PEDS-05-01
Not Provided
Not Provided
Cubist Pharmaceuticals
Not Provided
Principal Investigator: Richard Jacobs, MD University of Arkansas
Cubist Pharmaceuticals
January 2007

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