We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates

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.
ClinicalTrials.gov Identifier: NCT00873327
Recruitment Status : Completed
First Posted : April 1, 2009
Results First Posted : May 30, 2013
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Sepsis Drug: piperacillin-tazobactam Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
Study Start Date : October 2009
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Piperacillin Pharmacokinetics (PK) [ Time Frame: 2-3 days after infant receives 1st drug dosing ]
    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



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 60 Days   (Child)
Sexes Eligible for Study:   All
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

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): 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

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
First Posted: April 1, 2009    Key Record Dates
Results First Posted: May 30, 2013
Last Update Posted: June 5, 2013
Last Verified: May 2013

Keywords provided by Phillip Brian Smith, Duke University Medical Center:
presumed sepsis

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Tazobactam
Penicillanic Acid
Piperacillin
Piperacillin, tazobactam drug combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action