Antimicrobial PK in Infants With Suspected or Confirmed Infection

Completed

• Conditions: Infection
• Interventions: Drug: Ampicillin; Drug: Metronidazole; Drug: Piperacillin/Tazobactam; Drug: Acyclovir; Drug: Amphotericin B; Drug: Ambisome; Drug: Anidulafungin; Drug: Caspofungin

• Registration Number: NCT00491426
• Lead Sponsor: Duke University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-06-22
• Study First Submitted QC: 2007-06-22
• Study First Posted: 2007-06-26
• Primary Completion: 2010-10
• Study Completion: 2010-11
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-16
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

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Exclusion Criteria

• Failure to consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
26-29 weeks	Piperacillin/Tazobactam	Subjects 26-29 weeks gestational age
<26 weeks	Ampicillin	Subjects \<26 weeks gestational age
<26 weeks	Piperacillin/Tazobactam	Subjects \<26 weeks gestational age
30-32 weeks	Anidulafungin	Subjects 30-32 weeks gestational age
30-32 weeks	Piperacillin/Tazobactam	Subjects 30-32 weeks gestational age
26-29 weeks	Acyclovir	Subjects 26-29 weeks gestational age
30-32 weeks	Ambisome	Subjects 30-32 weeks gestational age
30-32 weeks	Acyclovir	Subjects 30-32 weeks gestational age
<26 weeks	Metronidazole	Subjects \<26 weeks gestational age
<26 weeks	Acyclovir	Subjects \<26 weeks gestational age
<26 weeks	Amphotericin B	Subjects \<26 weeks gestational age
<26 weeks	Ambisome	Subjects \<26 weeks gestational age
<26 weeks	Anidulafungin	Subjects \<26 weeks gestational age
<26 weeks	Caspofungin	Subjects \<26 weeks gestational age
26-29 weeks	Ampicillin	Subjects 26-29 weeks gestational age
26-29 weeks	Metronidazole	Subjects 26-29 weeks gestational age
26-29 weeks	Amphotericin B	Subjects 26-29 weeks gestational age
26-29 weeks	Ambisome	Subjects 26-29 weeks gestational age
26-29 weeks	Anidulafungin	Subjects 26-29 weeks gestational age
26-29 weeks	Caspofungin	Subjects 26-29 weeks gestational age
30-32 weeks	Ampicillin	Subjects 30-32 weeks gestational age
30-32 weeks	Amphotericin B	Subjects 30-32 weeks gestational age
30-32 weeks	Metronidazole	Subjects 30-32 weeks gestational age
30-32 weeks	Caspofungin	Subjects 30-32 weeks gestational age

Trial Locations

Locations (6)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of California at San Diego; 🇺🇸 La Jolla, California, United States

Kosair Children's Hospital; 🇺🇸 Louisville, Kentucky, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Children's Hospital of Michigan, Wayne State University; 🇺🇸 Detroit, Michigan, United States