Antimicrobial PK in Infants With Suspected or Confirmed Infection

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491426
• Other study ID #: Pro00015379
• Secondary ID: PPRU 10824
• Status: Completed
• Phase: Phase 1
• First received: June 22, 2007
• Last updated: November 16, 2012
• Start date: January 2006
• Est. completion date: November 2010

Study information

• Verified date: November 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Days

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infection

Intervention

Drug:
• Ampicillin
Drug prescribed per routine medical care.
• Metronidazole
Drug prescribed per routine medical care.
• Piperacillin/Tazobactam
Drug prescribed per routine medical care.
• Acyclovir
Drug prescribed per routine medical care.
• Amphotericin B
Drug prescribed per routine medical care.
• Ambisome
Drug prescribed per routine medical care.
• Anidulafungin
Drug prescribed per routine medical care.
• Caspofungin
Drug prescribed per routine medical care.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Children's Hospital of Michigan, Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	University of California at San Diego	La Jolla	California
United States	Kosair Children's Hospital	Louisville	Kentucky
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Pediatric Pharmacology Research Units Network

Country where clinical trial is conducted

United States,