Overview

Safety and Pharmacokinetics of Piperacillin-tazobactam Extended Infusion in Infants and Children (PIP-TAZO)

Status:
Unknown status

Trial end date:
2018-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

St. Justine's Hospital

Treatments:

Penicillanic Acid
Piperacillin
Piperacillin, Tazobactam Drug Combination
Tazobactam

Criteria

Study population #1: Normal renal function

Inclusion Criteria:

- Children 2 months - 6 years of age*

- Piperacillin-tazobactam indicated per standard of care

- Informed consent

Exclusion Criteria:

- 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

Inclusion Criteria:

- 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.

Exclusion Criteria:

- History of anaphylaxis to β-lactams

- Supported with extracorporeal membrane oxygenation (ECMO)

- On renal replacement therapy

- Cystic fibrosis

- Chronic renal insufficiency defined as defined as a glomerular filtration rate of
10-60 mL/min/1.73 m2