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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00136292
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : December 20, 2017
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

August 25, 2005
August 29, 2005
December 20, 2017
August 24, 2005
August 1, 2006   (Final data collection date for primary outcome measure)
Same as current
Complete list of historical versions of study NCT00136292 on Archive Site
Same as current
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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
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Gram-positive Bacterial Infections
Drug: daptomycin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 9, 2006
August 1, 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
DAP-PEDS-05-01 ( Other Identifier: Cubist Study Number )
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Plan to Share IPD: Yes
Plan Description:

URL: http://
Cubist Pharmaceuticals LLC
Cubist Pharmaceuticals LLC
Not Provided
Principal Investigator: Richard Jacobs, MD University of Arkansas
Cubist Pharmaceuticals LLC
December 2017

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