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Antimicrobial PK in Infants With Suspected or Confirmed Infection

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection

Intervention: Ampicillin (Drug); Metronidazole (Drug); Piperacillin/Tazobactam (Drug); Acyclovir (Drug); Amphotericin B (Drug); Ambisome (Drug); Anidulafungin (Drug); Caspofungin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Danny Benjamin, MD, Principal Investigator, Affiliation: PPRU
Mary Jayne Kennedy, Pharm, D, Principal Investigator, Affiliation: Louisville-PPRU


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.

Clinical Details

Official title: Antimicrobial Pharmacokinetics in High Risk Infants (Urinary Proteomics in Antimicrobial/Antifungal-Treated Newborns - add-on Study)

Study design: Time Perspective: Retrospective

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.


Minimum age: N/A. Maximum age: 120 Days. Gender(s): Both.


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

Locations and Contacts

University of California at San Diego, La Jolla, California 92103, United States

Children's National Medical Center, Washington, District of Columbia 20010, United States

Kosair Children's Hospital, Louisville, Kentucky 40202, United States

Children's Hospital of Michigan, Wayne State University, Detroit, Michigan 48201, United States

Duke University Medical Center, Durham, North Carolina 27705, United States

University of Texas Southwestern Medical Center, Dallas, Texas 75235, United States

Additional Information

Starting date: January 2006
Last updated: November 16, 2012

Page last updated: August 23, 2015

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