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An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University
ClinicalTrials.gov Identifier:
NCT00942149
First received: July 2, 2009
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

This is a safety and pharmacokinetic study of single-dose daptomycin in infants > 48 hours and < 120 days of age with suspected systemic infections. The investigators will enroll a total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6 mg/kg of daptomycin will yield an AUC <740 mch*hr/mL.


Condition Intervention Phase
Sepsis
 Drug: Daptomycin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
Drug Information available for: Daptomycin
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • PK of Daptomycin [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Area under the curve


Secondary Outcome Measures:
  • Adverse Events Will be Monitored. [ Time Frame: 7 days following last dose of study drug ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daptomycin cohort Drug: Daptomycin
single dose of 6 mg/kg of daptomycin

  Eligibility

Ages Eligible for Study:   up to 120 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. > 48 hours and <120 days of age at the time of daptomycin administration
  2. Sufficient venous access to permit administration of study medication
  3. Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry
  4. Availability and willingness of the parent/legally authorized representative to provide written informed consent

Exclusion Criteria:

  1. History of anaphylaxis attributed to daptomycin
  2. Previous participation in the study
  3. Exposure to daptomycin in the month prior to the study
  4. Serum creatinine >1.0 mg/dL
  5. Concomitant administration of tobramycin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942149

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: P Brian Smith, MD MHS Duke University
  More Information

No publications provided

Responsible Party: Phillip Brian Smith, Associate Professor of Pediatrics, Duke University
ClinicalTrials.gov Identifier: NCT00942149     History of Changes
Other Study ID Numbers: dapto1
Study First Received: July 2, 2009
Results First Received: October 18, 2012
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Duke University:
Infants
Daptomycin

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
 Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013