Clinical trial NCT00491426: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: Infection
Anti-Infective Agents
Antifungal Agents
Proteomics
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Pediatric Pharmacology Research Units Network
First posted: 2007-06-26
Enrollment: 450
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants \<32 weeks gestational age at birth at risk of infections.

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California at San Diego
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: Detroit
country: United States
facility: Children's Hospital of Michigan, Wayne State University
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: PPRU
name: Danny Benjamin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Louisville-PPRU
name: Mary Jayne Kennedy, Pharm, D
role: PRINCIPAL_INVESTIGATOR
References: