Status:
COMPLETED
Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
Lead Sponsor:
Phillip Brian Smith
Conditions:
Sepsis
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE1
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 o...
Detailed Description
Procedures Prior to Receipt of First Dose of Study Drug Parental/Guardian Permission Prior to the start of any study-related procedure, a signed and dated informed consent and HIPAA authorization mus...
Eligibility Criteria
Inclusion
- Written permission from parent or legal guardian
- \< 61 days of age
- Likely to survive beyond the first 48 hours after enrollment
- Sufficient intravascular access (either peripheral or central) to receive study drug.
- AND ONE OF THE FOLLOWING
- Suspected systemic infection
- Receiving piperacillin-tazobactam as part of standard of care
Exclusion
- History of allergic reactions to any penicillin, cephalosporins, or beta-lactamase inhibitors
- Urine output \< 0.5 mL/hr/kg over the prior 24 hours
- Serum creatinine \> 1.2 mg/dL
- Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00873327
Start Date
October 1 2009
End Date
July 1 2010
Last Update
October 3 2018
Active Locations (4)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
2
Wesley Medical Center
Wichita, Kansas, United States, 67214
3
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
4
Duke University Medical Center
Durham, North Carolina, United States, 27710