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Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates

NCT00873327 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-10-03

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Phillip Brian Smith

    lead OTHER

Principal Investigators

  • Phillip B. Smith, MD · Duke Universtity Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
60 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00873327 on ClinicalTrials.gov