We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00942149
Recruitment Status : Completed
First Posted : July 20, 2009
Results First Posted : December 12, 2012
Last Update Posted : July 15, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Sepsis Drug: Daptomycin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
Study Start Date : January 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Daptomycin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Daptomycin cohort Drug: Daptomycin
single dose of 6 mg/kg of daptomycin


Outcome Measures

Primary Outcome Measures :
  1. PK of Daptomycin [ Time Frame: 24 hours ]
    Area under the curve


Secondary Outcome Measures :
  1. Adverse Events Will be Monitored. [ Time Frame: 7 days following last dose of study drug ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 120 Days   (Child)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00942149     History of Changes
Other Study ID Numbers: Pro00019311
dapto1 ( Other Identifier: DUMC )
First Posted: July 20, 2009    Key Record Dates
Results First Posted: December 12, 2012
Last Update Posted: July 15, 2013
Last Verified: June 2013

Keywords provided by Duke University:
Infants
Daptomycin

Additional relevant MeSH terms:
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents