Antimicrobial PK in Infants With Suspected or Confirmed Infection

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Pediatric Pharmacology Research Units Network
• Treatments: Acyclovir; Amphotericin B; Ampicillin; Anidulafungin; Anti-Infective Agents; Caspofungin; Liposomal amphotericin B; Metronidazole; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

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