Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates

NCT00873327 | Completed Phase 1 Results

• 1 other identifier: Pro00020476
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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. 1.\< 32 weeks gestational age (GA) and \< 14 days postnatal age (PNA)
2. 2.\< 32 weeks gestational age and \>=14 days postnatal age
3. 3.\>=32 weeks gestational age and \< 14 days postnatal age
4. 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

Sepsis

Keywords

presumed sepsis

Outcome Measures

Primary Outcomes (1)

• Piperacillin Pharmacokinetics (PK)

  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

  2-3 days after infant receives 1st drug dosing

Study Arms (1)

1

ACTIVE COMPARATOR

Open label -- 6 interval doses

Drug: piperacillin-tazobactam

Interventions

piperacillin-tazobactam DRUG

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

1

Eligibility Criteria

• Age: Up to 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Phillip Brian Smith: lead

Study Sites (4)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Cohen-Wolkowiez M, Benjamin DK Jr, Ross A, James LP, Sullivan JE, Walsh MC, Zadell A, Newman N, White NR, Kashuba AD, Ouellet D. Population pharmacokinetics of piperacillin using scavenged samples from preterm infants. Ther Drug Monit. 2012 Jun;34(3):312-9. doi: 10.1097/FTD.0b013e3182587665.

  PMID: 22569355 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Brian Smith, MD. MPH
• Organization: Duke University Medical Center

brian.smith@duke.edu

919-668-8951

Study Officials

• Phillip B. Smith, MD

  Duke Universtity Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: April 1, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 3, 2018
• Results First Posted: May 30, 2013

Record last verified: 2018-09

Locations

US (4)