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Antimicrobial PK in Infants With Suspected or Confirmed Infection

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ClinicalTrials.gov Identifier: NCT00491426
Recruitment Status : Completed
First Posted : June 26, 2007
Last Update Posted : November 19, 2012
Sponsor:
Collaborator:
Pediatric Pharmacology Research Units Network
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date June 22, 2007
First Posted Date June 26, 2007
Last Update Posted Date November 19, 2012
Study Start Date January 2006
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00491426 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Antimicrobial PK in Infants With Suspected or Confirmed Infection
Official Title Antimicrobial Pharmacokinetics in High Risk Infants (Urinary Proteomics in Antimicrobial/Antifungal-Treated Newborns - add-on Study)
Brief Summary The purpose of this protocol is to provide a mechanism for the ongoing collection of blood and urine samples in newborns that will be used to measure levels of antimicrobial products used in the newborn population where there are limited pharmacokinetic data in either premature or term infants.
Detailed Description

Greater than 90% of infants born <32 weeks admitted to critical care nurseries are treated with antimicrobial agents during their NICU hospitalization. Most antimicrobial products used in the neonatal population lack some aspect of pharmacokinetic information specific to neonates. Dosing is based largely on pharmacokinetic data from older children or in some cases, adults. This study will also establish a bank of urine samples from newborns treated with antimicrobial and/or antifungal therapy and to characterize the urinary proteome in selected samples. The sites of the NIH-sponsored Pediatric Pharmacology Research Network (PPRU) have access to appropriate assays using microliter amounts of serum and a large pool of potential subjects to generate meaningful data that will

  1. Guide dosing of commonly used antimicrobial agents, and
  2. Provide preliminary data for future industry and government trials in the nursery.
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Premature infants <32 weeks gestational age at birth at risk of infections.
Condition Infection
Intervention
  • Drug: Ampicillin
    Drug prescribed per routine medical care.
  • Drug: Metronidazole
    Drug prescribed per routine medical care.
  • Drug: Piperacillin/Tazobactam
    Drug prescribed per routine medical care.
  • Drug: Acyclovir
    Drug prescribed per routine medical care.
  • Drug: Amphotericin B
    Drug prescribed per routine medical care.
  • Drug: Ambisome
    Drug prescribed per routine medical care.
  • Drug: Anidulafungin
    Drug prescribed per routine medical care.
  • Drug: Caspofungin
    Drug prescribed per routine medical care.
Study Groups/Cohorts
  • <26 weeks
    Subjects <26 weeks gestational age
    Interventions:
    • Drug: Ampicillin
    • Drug: Metronidazole
    • Drug: Piperacillin/Tazobactam
    • Drug: Acyclovir
    • Drug: Amphotericin B
    • Drug: Ambisome
    • Drug: Anidulafungin
    • Drug: Caspofungin
  • 26-29 weeks
    Subjects 26-29 weeks gestational age
    Interventions:
    • Drug: Ampicillin
    • Drug: Metronidazole
    • Drug: Piperacillin/Tazobactam
    • Drug: Acyclovir
    • Drug: Amphotericin B
    • Drug: Ambisome
    • Drug: Anidulafungin
    • Drug: Caspofungin
  • 30-32 weeks
    Subjects 30-32 weeks gestational age
    Interventions:
    • Drug: Ampicillin
    • Drug: Metronidazole
    • Drug: Piperacillin/Tazobactam
    • Drug: Acyclovir
    • Drug: Amphotericin B
    • Drug: Ambisome
    • Drug: Anidulafungin
    • Drug: Caspofungin
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 Completed
Actual Enrollment
 (submitted: August¬†31,¬†2011)
450
Original Enrollment Not Provided
Actual Study Completion Date November 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Infants ≤32 weeks and 6 days EGA with high probability of receiving one of the antimicrobial agents listed are eligible for study.
  • Age younger than 120 days
  • Written informed consent from parent or legal guardian
  • Infants likely to survive beyond 48 hours after enrollment

Exclusion Criteria:

  • Failure to consent
Sex/Gender
Sexes Eligible for Study: All
Ages up to 120 Days   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00491426
Other Study ID Numbers Pro00015379
PPRU 10824 ( Other Identifier: Network Protocol Identifier )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Pediatric Pharmacology Research Units Network
Investigators
Principal Investigator: Danny Benjamin, MD PPRU
Principal Investigator: Mary Jayne Kennedy, Pharm, D Louisville-PPRU
PRS Account Duke University
Verification Date November 2012