Antimicrobial PK in Infants With Suspected or Confirmed Infection

Duke University

Status: Completed

Conditions: Infection

Treatments: Drug: Ampicillin; Drug: Piperacillin/Tazobactam; Drug: Anidulafungin; Drug: Amphotericin B; Drug: Ambisome; Drug: Caspofungin; Drug: Metronidazole; Drug: Acyclovir

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT00491426

Pro00015379

PPRU 10824 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 patients

Sex: All

Ages: Under 120 days old

Volunteers: No Healthy Volunteers

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

Trial design

450 participants in 3 patient groups

<26 weeks

Description:

Subjects \<26 weeks gestational age

Treatment:

Drug: Anidulafungin

Drug: Piperacillin/Tazobactam

Drug: Amphotericin B

Drug: Caspofungin

Drug: Acyclovir

Drug: Ampicillin

Drug: Metronidazole

Drug: Ambisome

26-29 weeks

Description:

Subjects 26-29 weeks gestational age

Treatment:

Drug: Anidulafungin

Drug: Piperacillin/Tazobactam

Drug: Amphotericin B

Drug: Caspofungin

Drug: Acyclovir

Drug: Ampicillin

Drug: Metronidazole

Drug: Ambisome

30-32 weeks

Description:

Subjects 30-32 weeks gestational age

Treatment:

Drug: Anidulafungin

Drug: Piperacillin/Tazobactam

Drug: Amphotericin B

Drug: Caspofungin

Drug: Acyclovir

Drug: Ampicillin

Drug: Metronidazole

Drug: Ambisome