We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antimicrobial PK in Infants With Suspected or Confirmed Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00491426
First Posted: June 26, 2007
Last Update Posted: November 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pediatric Pharmacology Research Units Network
Information provided by (Responsible Party):
Duke University
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 120 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00491426     History of Changes
Other Study ID Numbers: Pro00015379
PPRU 10824 ( Other Identifier: Network Protocol Identifier )
First Submitted: June 22, 2007
First Posted: June 26, 2007
Last Update Posted: November 19, 2012
Last Verified: November 2012

Keywords provided by Duke University:
Infection
Anti-Infective Agents
Antifungal Agents
Proteomics

Additional relevant MeSH terms:
Infection
Communicable Diseases
Tazobactam
Liposomal amphotericin B
Caspofungin
Piperacillin, tazobactam drug combination
Anidulafungin
Metronidazole
Anti-Infective Agents
Amphotericin B
Piperacillin
Acyclovir
Ampicillin
Penicillanic Acid
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Amebicides
Antifungal Agents
Antiviral Agents