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Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates

This study has been completed.
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00873327
First received: March 30, 2009
Last updated: October 6, 2010
Last verified: October 2010
History of Changes
  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 and < 14 days postnatal age
  2. < 32 weeks gestational age and >=14 days postnatatal 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: Allocation: Non-Randomized
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:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Piperacillin and tazobactam steady state pharmacokinetics including half life, clearance, and volume of distribution [ Time Frame: dose 4-6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of piperacillin/tazobactam during the study and for 7 days following the last dose of study drug. [ Time Frame: 1st dose to 7 days following last dose ] [ Designated as safety issue: Yes ]

Estimated 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
Experimental: 1
piperacillin-tazobactam - 6 intravenous 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
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
Duke University
  More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: P. Brian Smith MD MHS Assistant Professor of Pediatrics, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00873327     History of Changes
Other Study ID Numbers: Pro2009
Study First Received: March 30, 2009
Last Updated: October 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
presumed sepsis

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Piperacillin
Penicillanic Acid
Piperacillin-tazobactam combination product
 Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013