Safety and Pharmacokinetics of Piperacillin-tazobactam Extended Infusion in Infants and Children (PIP-TAZO)
PIP-TAZO
1 other identifier
interventional
141
1 country
1
Brief Summary
Severe infection is one of the main causes of disease in hospitalized children and can be deadly. With the lack of novel antibiotics approved in children and the emergence of drug resistant bacteria, there is a critical need to optimize dosing of existing antibiotics. Piperacillin-tazobactam is an antibiotic frequently used for treatment of severe infection in children in Canadian hospitals. To optimize this antibiotic's efficacy despite the rise of antibiotic resistance, alternative dosing strategy is commonly used in adults, which consists of prolonging the time during which the drug is infused (4 hours instead of 30 min). Children clear piperacillin-tazobactam from their bodies at a slower rate than adults, consequently extended-infusion strategy cannot be directly extrapolated from adult to children. We believe that younger children need piperacillin-tazobactam infusions that are shorter compared to adults to achieve appropriate concentrations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 9, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 19, 2018
April 1, 2018
2.9 years
June 2, 2015
April 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Evaluation of Clearance (CL) for piperacillin and tazobactam
Treatment days 1-14 followed by a safety observation period of 3 days after the last study dose.
up to 14 days
Proportion of subjects who achieve Pharmacodynamic target (at least 50% of free plasma piperacillin concentration above the MIC [50% fT > MIC])
Treatment days 1-14 followed by a safety observation period of 3 days after the last study dose.
up to 14 days
Evaluation of Volume of distribution (V) for piperacillin and tazobactam
Treatment days 1-14 followed by a safety observation period of 3 days after the last study dose.
up to 14 days
Secondary Outcomes (1)
Proportion of subjects experiencing adverse events (AEs)
up to 17 days
Study Arms (1)
Piperacillin-tazobactam
EXPERIMENTALPiperacillin-tazobactam administration (fixed combination, ratio piperacillin:tazobactam = 8:1). Recruitment stratified by age group and pediatric populations to ensure good representation of those subgroups. Maximum dose: 16g/day. Treatment duration: up to 14 days depending to the treating physician. Patients with Normal Renal function: * Pediatric and surgery units: 2-5 months (7); 6-11 months (7); 12-23 months (7); 2-6 years (16) * Pediatric intensive care unit (PICU): 2-5 months (7); 6-11 months (7); 12-23 months (7); 2-6 years (16) * Haematology-oncology unit: 2-5 months (7); 6-11 months (7); 12-23 months (7); 2-6 years (16) Patients with Acute Kidney injury: * Pediatric and surgery units: 2 months-6 years (10) * PICU: 2 months-6 years (10) * Haematology-oncology unit: 2 months-6 years (10)
Interventions
* Normal renal function receiving new optimized piperacillin-tazobactam dosing regimen per age, dosing (mg/kg), duration of infusion * Age (2-5 months): 80 mg/kg/dose of medication every 8 hours for 4 hours * Age (≥6 months-6y): 130 mg/kg/dose of medication every 8 hours for 4 hours * Acute Kidney injury : Dosing as prescribed by treating physician
Eligibility Criteria
You may qualify if:
- Children 2 months - 6 years of age\*
- Piperacillin-tazobactam indicated per standard of care
- Informed consent
You may not qualify if:
- Insufficient venous access to allow extended infusion
- History of anaphylaxis to β-lactams
- Supported with extracorporeal membrane oxygenation (ECMO)
- On renal replacement therapy
- Cystic fibrosis
- Acute Kidney injury
- Chronic renal insufficiency defined as defined as a glomerular filtration rate of 10-60 mL/min/1.73 m2
- Study population #2: Acute Kidney injury
- Children 2 months - 6 years of age
- Piperacillin-tazobactam indicated per standard of care
- Informed consent
- Acute Kidney injury defined as the following:
- Doubling of serum creatinine according to upper limit of normal for age and gender or
- Doubling of baseline serum creatinine (defined as the creatinine level at admission, if the value is within normal limit for age and gender) We wil use the smaller value of these 2 definitions to diagnose acute kidney injury in a given subject.
- History of anaphylaxis to β-lactams
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Justine's Hospital
Montreal, Quebec, H3T 1C5, Canada
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie Autmizguine, MD, MHS
St. Justine's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MHS
Study Record Dates
First Submitted
June 2, 2015
First Posted
June 9, 2015
Study Start
January 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
April 19, 2018
Record last verified: 2018-04