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NCT00491426

Antimicrobial PK in Infants With Suspected or Confirmed Infection

NCT ID: NCT00491426

Last Updated: 2012-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-11-30

Brief Summary

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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

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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.

Conditions

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Infection

Keywords

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Infection Anti-Infective Agents Antifungal Agents Proteomics

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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<26 weeks

Subjects \<26 weeks gestational age

Ampicillin

Intervention Type DRUG

Drug prescribed per routine medical care.

Metronidazole

Intervention Type DRUG

Drug prescribed per routine medical care.

Piperacillin/Tazobactam

Intervention Type DRUG

Drug prescribed per routine medical care.

Acyclovir

Intervention Type DRUG

Drug prescribed per routine medical care.

Amphotericin B

Intervention Type DRUG

Drug prescribed per routine medical care.

Ambisome

Intervention Type DRUG

Drug prescribed per routine medical care.

Anidulafungin

Intervention Type DRUG

Drug prescribed per routine medical care.

Caspofungin

Intervention Type DRUG

Drug prescribed per routine medical care.

26-29 weeks

Subjects 26-29 weeks gestational age

Ampicillin

Intervention Type DRUG

Drug prescribed per routine medical care.

Metronidazole

Intervention Type DRUG

Drug prescribed per routine medical care.

Piperacillin/Tazobactam

Intervention Type DRUG

Drug prescribed per routine medical care.

Acyclovir

Intervention Type DRUG

Drug prescribed per routine medical care.

Amphotericin B

Intervention Type DRUG

Drug prescribed per routine medical care.

Ambisome

Intervention Type DRUG

Drug prescribed per routine medical care.

Anidulafungin

Intervention Type DRUG

Drug prescribed per routine medical care.

Caspofungin

Intervention Type DRUG

Drug prescribed per routine medical care.

30-32 weeks

Subjects 30-32 weeks gestational age

Ampicillin

Intervention Type DRUG

Drug prescribed per routine medical care.

Metronidazole

Intervention Type DRUG

Drug prescribed per routine medical care.

Piperacillin/Tazobactam

Intervention Type DRUG

Drug prescribed per routine medical care.

Acyclovir

Intervention Type DRUG

Drug prescribed per routine medical care.

Amphotericin B

Intervention Type DRUG

Drug prescribed per routine medical care.

Ambisome

Intervention Type DRUG

Drug prescribed per routine medical care.

Anidulafungin

Intervention Type DRUG

Drug prescribed per routine medical care.

Caspofungin

Intervention Type DRUG

Drug prescribed per routine medical care.

Interventions

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Ampicillin

Drug prescribed per routine medical care.

Intervention Type DRUG

Metronidazole

Drug prescribed per routine medical care.

Intervention Type DRUG

Piperacillin/Tazobactam

Drug prescribed per routine medical care.

Intervention Type DRUG

Acyclovir

Drug prescribed per routine medical care.

Intervention Type DRUG

Amphotericin B

Drug prescribed per routine medical care.

Intervention Type DRUG

Ambisome

Drug prescribed per routine medical care.

Intervention Type DRUG

Anidulafungin

Drug prescribed per routine medical care.

Intervention Type DRUG

Caspofungin

Drug prescribed per routine medical care.

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

120 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pediatric Pharmacology Research Units Network

NETWORK

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danny Benjamin, MD

Role: PRINCIPAL_INVESTIGATOR

PPRU

Mary Jayne Kennedy, Pharm, D

Role: PRINCIPAL_INVESTIGATOR

Louisville-PPRU

Locations

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University of California at San Diego

La Jolla, California, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Kosair Children's Hospital

Louisville, Kentucky, United States

Site Status

Children's Hospital of Michigan, Wayne State University

Detroit, Michigan, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PPRU 10824

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00015379

Identifier Type: -

Identifier Source: org_study_id