Antimicrobial PK in Infants With Suspected or Confirmed Infection

This study has been completed.
Sponsor:
Collaborator:
Pediatric Pharmacology Research Units Network
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00491426
First received: June 22, 2007
Last updated: November 16, 2012
Last verified: November 2012
  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 1

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:


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

  1. Guide dosing of commonly used antimicrobial agents, and
  2. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Duke University
ClinicalTrials.gov Identifier: NCT00491426     History of Changes
Other Study ID Numbers: Pro00015379, PPRU 10824
Study First Received: June 22, 2007
Last Updated: November 16, 2012
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014