Antimicrobial PK in Infants With Suspected or Confirmed Infection

Completed

Conditions studied: Infection

In brief

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.

Key facts

Study ID

NCT00491426

Run by

Duke University

People needed

450

Starts

2006-01-01

Expected to finish

2010-11-01

Last updated by the study team

2012-11-19

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Failure to consent

Where it is running

• University of California at San Diego — La Jolla, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Kosair Children's Hospital — Louisville, Kentucky, 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 Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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