drugset / Trial / NCT02466438

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

NCT02466438

Phase 1 Unknown 141 enrolled St. Justine's Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-01
Primary completion
2018-12
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 80 mg/kg
Subject Amoxicillin Other / unclassified 130 mg/kg

Indications