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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00942149
First received: July 2, 2009
Last updated: July 1, 2013
Last verified: June 2013
  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:


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
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: 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: Duke University
ClinicalTrials.gov Identifier: NCT00942149     History of Changes
Other Study ID Numbers: Pro00019311, dapto1
Study First Received: July 2, 2009
Results First Received: October 18, 2012
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Duke University:
Infants
Daptomycin

Additional relevant MeSH terms:
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014