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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:
ClinicalTrials.gov Identifier:
NCT00136292
First Posted: August 29, 2005
Last Update Posted: January 18, 2007
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.
Information provided by:
Cubist Pharmaceuticals LLC
  Purpose
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.

Condition Intervention Phase
Gram-Positive Bacterial Infections Drug: daptomycin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals LLC:

Primary Outcome Measures:
  • Pharmacokinetic

Secondary Outcome Measures:
  • Tolerability

Estimated Enrollment: 24
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136292


Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202
United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
Principal Investigator: Richard Jacobs, MD University of Arkansas
  More Information

ClinicalTrials.gov Identifier: NCT00136292     History of Changes
Other Study ID Numbers: DAP-PEDS-05-01
First Submitted: August 25, 2005
First Posted: August 29, 2005
Last Update Posted: January 18, 2007
Last Verified: January 2007

Keywords provided by Cubist Pharmaceuticals LLC:
Gram-Positive Infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Gram-Positive Bacterial Infections
Anti-Bacterial Agents
Daptomycin
Anti-Infective Agents