Antimicrobial PK in Infants With Suspected or Confirmed Infection - Full Text View

Sponsor:	Duke University
Collaborator:	Pediatric Pharmacology Research Units Network
Information provided by (Responsible Party):	Michael Cohen-Wolkowiez, Duke University
ClinicalTrials.gov Identifier:	NCT00491426

Purpose

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.

Condition	Intervention	Phase
Infection	Drug: Ampicillin Drug: Metronidazole Drug: Piperacillin/Tazobactam Drug: Acyclovir Drug: Amphotericin B Drug: Ambisome Drug: Anidulafungin Drug: Caspofungin	Phase I

Study Type:	Observational
Study Design:	Time Perspective: Retrospective
Official Title:	Antimicrobial Pharmacokinetics in High Risk Infants (Urinary Proteomics in Antimicrobial/Antifungal-Treated Newborns - add-on Study)

Resource links provided by NLM:

Drug Information available for: Ampicillin sodium Ampicillin Acyclovir Piperacillin sodium Piperacillin Metronidazole hydrochloride Acyclovir sodium Metronidazole phosphate Tazobactam Caspofungin Anidulafungin Caspofungin Acetate Metronidazole Amphotericin B Ampicillin trihydrate

U.S. FDA Resources

Further study details as provided by Duke University:

Enrollment:	450
Study Start Date:	January 2006
Study Completion Date:	November 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
<26 weeks Subjects <26 weeks gestational age	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.
26-29 weeks Subjects 26-29 weeks gestational age	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.
30-32 weeks Subjects 30-32 weeks gestational age	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.

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

Guide dosing of commonly used antimicrobial agents, and
Provide preliminary data for future industry and government trials in the nursery.

Eligibility

Ages Eligible for Study:	up to 120 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Premature infants <32 weeks gestational age at birth at risk of infections.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491426

Locations

United States, California
University of California at San Diego
La Jolla, California, United States, 92103
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Michigan
Children's Hospital of Michigan, Wayne State University
Detroit, Michigan, United States, 48201
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235

Sponsors and Collaborators

Duke University

Pediatric Pharmacology Research Units Network

Investigators

Principal Investigator:	Danny Benjamin, MD	PPRU
Principal Investigator:	Mary Jayne Kennedy, Pharm, D	Louisville-PPRU

More Information

No publications provided

Responsible Party:	Michael Cohen-Wolkowiez, Assistant Professor, Department of Pediatrics, Duke University
ClinicalTrials.gov Identifier:	NCT00491426 History of Changes
Other Study ID Numbers:	PPRU 10824
Study First Received:	June 22, 2007
Last Updated:	August 31, 2011
Health Authority:	United States: Federal Government

Keywords provided by Duke University:

Infection
Anti-Infective Agents
Antifungal Agents
Proteomics

Additional relevant MeSH terms:

Acyclovir
Liposomal amphotericin B
Piperacillin-tazobactam combination product
Anidulafungin
Caspofungin
Amphotericin B
Ampicillin
Anti-Infective Agents
Piperacillin
Metronidazole
Penicillanic Acid
Antifungal Agents

Tazobactam
Antiviral Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012