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Antimicrobial PK in Infants With Suspected or Confirmed Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00491426
First Posted: June 26, 2007
Last Update Posted: November 19, 2012
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.
Collaborator:
Pediatric Pharmacology Research Units Network
Information provided by (Responsible Party):
Duke University
June 22, 2007
June 26, 2007
November 19, 2012
January 2006
October 2010   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00491426 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Antimicrobial PK in Infants With Suspected or Confirmed Infection
Antimicrobial Pharmacokinetics in High Risk Infants (Urinary Proteomics in Antimicrobial/Antifungal-Treated Newborns - add-on Study)
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.

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.
Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Premature infants <32 weeks gestational age at birth at risk of infections.
Infection
  • 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.
  • <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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
November 2010
October 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 120 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00491426
Pro00015379
PPRU 10824 ( Other Identifier: Network Protocol Identifier )
Yes
Not Provided
Not Provided
Duke University
Duke University
Pediatric Pharmacology Research Units Network
Principal Investigator: Danny Benjamin, MD PPRU
Principal Investigator: Mary Jayne Kennedy, Pharm, D Louisville-PPRU
Duke University
November 2012