Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00873327
First received: March 30, 2009
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety of piperacillin-tazobactam in infants < 61 days of age with suspected sepsis. There will be four cohorts of 8 infants each:

  1. < 32 weeks gestational age (GA) and < 14 days postnatal age (PNA)
  2. < 32 weeks gestational age and >=14 days postnatal age
  3. >=32 weeks gestational age and < 14 days postnatal age
  4. >=32 weeks gestational age and >=14 days postnatal age. The study requires administration of 6 doses of study drug along with other antimicrobials per standard of care followed by 1 week of safety monitoring. Four 200 µL pK samples will be obtained at steady state. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of broad spectrum empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.

Condition Intervention Phase
Sepsis
Drug: piperacillin-tazobactam
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Piperacillin Pharmacokinetics (PK) [ Time Frame: 2-3 days after infant receives 1st drug dosing ] [ Designated as safety issue: No ]
    To study how Piperacillin is metabolized in the body by measuring the drug concentration in plasma samples collected at different time points during the study


Enrollment: 32
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Open label -- 6 interval doses
Drug: piperacillin-tazobactam

6 doses intravenously at the following doses:

Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6

Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6

≥ 14 days PNA 100 mg/kg Q6


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 60 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written permission from parent or legal guardian
  2. < 61 days of age
  3. Likely to survive beyond the first 48 hours after enrollment
  4. Sufficient intravascular access (either peripheral or central) to receive study drug.

AND ONE OF THE FOLLOWING

  1. Suspected systemic infection
  2. Receiving piperacillin-tazobactam as part of standard of care

Exclusion Criteria:

  1. History of allergic reactions to any penicillin, cephalosporins, or beta-lactamase inhibitors
  2. Urine output < 0.5 mL/hr/kg over the prior 24 hours
  3. Serum creatinine > 1.2 mg/dL
  4. Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study
  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: NCT00873327

Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Kansas
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Phillip Brian Smith
Investigators
Principal Investigator: Phillip B. Smith, MD Duke Universtity Medical Center
  More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Phillip Brian Smith, Assistant Professor of Pediatrics, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00873327     History of Changes
Other Study ID Numbers: Pro00020476
Study First Received: March 30, 2009
Results First Received: November 25, 2012
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
presumed sepsis

Additional relevant MeSH terms:
Piperacillin
Piperacillin-tazobactam combination product
Penicillanic Acid
Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014