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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
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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:

Primary Outcome Measures:
  • Pharmacokinetic

Secondary Outcome Measures:
  • Tolerability

Estimated Enrollment: 24
  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Richard Jacobs, MD University of Arkansas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00136292     History of Changes
Other Study ID Numbers: DAP-PEDS-05-01
Study First Received: August 25, 2005
Last Updated: January 16, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
Gram-Positive Infection

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

ClinicalTrials.gov processed this record on November 25, 2014