Antimicrobial PK in Infants With Suspected or Confirmed Infection
Information source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information obtained from ClinicalTrials.gov on October 04, 2010
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: Recruiting
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s):
Danny Benjamin, MD, Principal Investigator, Affiliation: PPRU
Mary Jayne Kennedy, Pharm, D, Principal Investigator, Affiliation: Louisville-PPRU
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.
Clinical Details
Official title: Antimicrobial Pharmacokinetics in High Risk Infants (Urinary Proteomics in Antimicrobial/Antifungal-Treated Newborns – Add-on Study)
Study design: Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal, 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.
Eligibility
Minimum age: N/A.
Maximum age: 120 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Infants â¤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; Not yet recruiting
Children's National Medical Center, Washington, District of Columbia 20010, United States; Not yet recruiting
Kosair Children's Hospital, Louisville, Kentucky 40202, United States; Recruiting
Elizabeth McDowell, RN, Phone: 502-629-5606
Mary Jane Kennedy, Pharm D., Principal Investigator
Children's Hospital of Michigan, Wayne State University, Detroit, Michigan 48201, United States; Recruiting
Ginger Steinhilber, RN, MS, CCRC, Phone: (313) 745â5287, Email: gsteinhilber@med.wayne.edu
Jacob Aranda, M.D., Ph.D., Principal Investigator
Duke University Medical Center, Durham, North Carolina 27705, United States; Recruiting
Kimberly Fisher, Ph.D., APRN, Phone: 919-681-4913, Email: Kimberly.fisher@duke.edu
Daniel Benjamin, MD, PhD, Principal Investigator
University of Texas Southwestern Medical Center, Dallas, Texas 75235, United States; Not yet recruiting
Hasan Jafri, M.D., Principal Investigator
Additional Information
Starting date: January 2006
Last updated: June 22, 2007
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