Recruiting
Phase 1

PIP-TAZO

Sponsor:

St. Justine's Hospital

Code:

NCT02466438

Conditions

Infection

Eligibility Criteria

Sex: All

Age: 0 - 6

Healthy Volunteers: Not accepted

Interventions

Piperacillin-tazobactam

Study Details

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.

Conditions

Infection

Study ID

NCT02466438

Start date

Jan, 2016

Status verified date

Apr, 2018

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 6

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

141 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Piperacillin-tazobactam

Piperacillin-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

Piperacillin-tazobactam

  • 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

Primary outcome measure

  • Evaluation of Clearance (CL) for piperacillin and tazobactam [ Time Frame: 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]) [ Time Frame: up to 14 days ]
  • Evaluation of Volume of distribution (V) for piperacillin and tazobactam [ Time Frame: up to 14 days ]

Central Contacts and Locations

Central contacts

Julie Autmizguine, MD, MHS

1 514-345-4931julie.autmizguine@umontreal.ca

Mariana Dumitrascu, MD

1 514-345-4931mariana.dumitrascu@recherche-ste-justine.qc.ca

Locations

St. Justine's Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Julie Autmizguine, MD, MHS

514 345-4931julie.autmizguine@umontreal.ca

Mariana Dumitrascu, MD

1514 345-4931mariana.dumitrascu@recherche-ste-justine.qc.ca

More Information

Sponsor

St. Justine's Hospital

Last update posted

Apr 19, 2018

Last verified

Apr, 2018

Keywords

  • Antibiotics
  • Piperacillin-tazobactam
  • Resistant bacteria

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2018-04-19.