Antimicrobial PK in Infants With Suspected or Confirmed Infection

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.

Conditions

• Infection

Interventions

DRUG

Ampicillin

Drug prescribed per routine medical care.

DRUG

Metronidazole

Drug prescribed per routine medical care.

DRUG

Piperacillin/Tazobactam

Drug prescribed per routine medical care.

DRUG

Acyclovir

Drug prescribed per routine medical care.

DRUG

Amphotericin B

Drug prescribed per routine medical care.

DRUG

Ambisome

Drug prescribed per routine medical care.

DRUG

Anidulafungin

Drug prescribed per routine medical care.

DRUG

Caspofungin

Drug prescribed per routine medical care.

Sponsors & Collaborators

• Pediatric Pharmacology Research Units Network

  collaborator NETWORK

• Duke University

  lead OTHER

Principal Investigators

• Danny Benjamin, MD · PPRU

• Mary Jayne Kennedy, Pharm, D · Louisville-PPRU

Eligibility

Max Age

120 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-01-31

Primary Completion

2010-10-31

Completion

2010-11-30

Countries

• United States

Study Locations