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An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates

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: NCT00850122
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University

Tracking Information
First Submitted Date  ICMJE January 22, 2009
First Posted Date  ICMJE February 24, 2009
Last Update Posted Date September 3, 2018
Study Start Date  ICMJE July 2013
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
Cefazolin pharmacokinetics including half life, clearance, and volume of distribution [ Time Frame: Dose 1 and Dose 4 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00850122 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
Safety [ Time Frame: 7 days following last dose of cefazolin ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
Official Title  ICMJE An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
Brief Summary This is a phase I open label multi-dose study to investigative the pharmacokinetics and safety of cefazolin in infants <121 days of age and < 28 weeks gestation with suspected sepsis. There will be two cohorts of 6 infants each: 1) >48 hours of age and ≤28 days and 2) >28 days of age and <121 days of age. The study requires administration of the study drug over 2 days followed by 1 week of safety monitoring. Six 200 µL pK samples will be obtained over the 2 days of drug administration. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sepsis
  • Prematurity
Intervention  ICMJE Drug: cefazolin

Cefazolin dosing - administered for 48 hours Dosage

≤28 days of age 25 mg/kg IV q12 29-120 days of age 25 mg/kg IV q8

Study Arms  ICMJE Experimental: Cefazolin

Dosage Number of Infants

≤28 days of age 25 mg/kg IV q12 6 29-120 days of age 25 mg/kg IV q8 6

Intervention: Drug: cefazolin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2016)
9
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2009)
12
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • < 28 weeks gestation at birth
  • > 48 hours and <121 days of age at the time of study drug administration
  • One of the following:

    • Suspected systemic infection
    • Receiving cefazolin for prophylaxis
    • Receiving cefazolin treatment of a systemic infection

Exclusion Criteria:

  • History of anaphylaxis attributed to a β-lactam
  • Exposure to cefazolin in the month prior to study
  • Serum creatinine > 1.7 mg/dL
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 120 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00850122
Other Study ID Numbers  ICMJE Pro00012011
1K23HD060040-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Phillip Brian Smith, Duke University
Study Sponsor  ICMJE Phillip Brian Smith
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE Not Provided
PRS Account Duke University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP