Antimicrobial PK in Infants With Suspected or Confirmed Infection

This study is currently recruiting participants.

Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), June 2007

First Received: June 22, 2007 No Changes Posted

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator:	Pediatric Pharmacology Research Units Network
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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:	Screening, Longitudinal, Defined Population, Retrospective Study
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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Study Start Date:

January 2006

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

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	Not yet recruiting
La Jolla, California, United States, 92103
United States, District of Columbia
Children's National Medical Center	Not yet recruiting
Washington, District of Columbia, United States, 20010
United States, Kentucky
Kosair Children's Hospital	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Elizabeth McDowell, RN 502-629-5606
Principal Investigator: Mary Jane Kennedy, Pharm D.
United States, Michigan
Children's Hospital of Michigan, Wayne State University	Recruiting
Detroit, Michigan, United States, 48201
Contact: Ginger Steinhilber, RN, MS, CCRC (313) 745–5287 gsteinhilber@med.wayne.edu
Principal Investigator: Jacob Aranda, M.D., Ph.D.
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27705
Contact: Kimberly Fisher, Ph.D., APRN 919-681-4913 Kimberly.fisher@duke.edu
Principal Investigator: Daniel Benjamin, MD, PhD
United States, Texas
University of Texas Southwestern Medical Center	Not yet recruiting
Dallas, Texas, United States, 75235
Principal Investigator: Hasan Jafri, M.D.

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

Study ID Numbers:	PPRU 10824/10825
Study First Received:	June 22, 2007
Last Updated:	June 22, 2007
ClinicalTrials.gov Identifier:	NCT00491426 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Infection
Anti-Infective Agents
Antifungal Agents
Proteomics

Additional relevant MeSH terms:

Abelcet
Metronidazole
Anti-Infective Agents
Communicable Diseases
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Piperacillin-tazobactam combination product
Liposomal amphotericin B
Infection
Anti-Bacterial Agents
Antiparasitic Agents
Therapeutic Uses
Antifungal Agents

Antibiotics, Antifungal
Amebicides
Amphotericin B
Caspofungin
Ampicillin
Enzyme Inhibitors
Tazobactam
Antiviral Agents
Pharmacologic Actions
Anidulafungin
Acyclovir
Penicillanic Acid
Radiation-Sensitizing Agents
Piperacillin

ClinicalTrials.gov processed this record on February 08, 2010