This study aims to evaluate the feasibility of an open randomized controlled study which would assess the proportion patients with obesity who will have a favorable pharmacodynamic parameter (i.e. fT\> 100% MIC) after 24 hours of piperacillin-tazobactam administered as a prolonged intermittent infusion compared to a standard infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
For patients with the prolonged infusion intervention, the piperacillin-tazobactam dose will be administered via 100 ml 0.9% NaCl mini-bags infused and a volumetric pump over 3 hours for piperacillin-tazobactam dosages every 6 hours or overs 4 hours for piperacillin-tazobactam dosages every 8 hours.
For patients with the standard infusion intervention, the piperacillin-tazobactam dose will be administered over 30 minutes for every piperacilline-tazobactam administered in the study (as instructed by the drug's monograph)
Hôpital Charles- Le Moyne
Greenfield Park, Quebec, Canada
Rate of adherence to the sampling protocol
Rate of patients whose blood collection takes place 24 hours after the start of administration of piperacillin-tazobactam according to the method of administration assigned during randomization
Time frame: At 24 hours of treatment of piperacillin-tazobactam after randomization
Recruitment rate
Proportion of patients meeting the eligibility criteria who consent to the study.
Time frame: At the randomization
Achievement of a prespecified number of patients recruited per month
Achievement of a number of patients recruited per month of 5 to 8 patients
Time frame: At the randomization
Proportion of eligible patients relative to the total population who received a piperacillin-tazobactam for the study period
Proportion of eligible patients relative to the total population who received a piperacilline-tazobactam for the study period
Time frame: From the screening period to the enrollment, assessed up to 24 hours after the start of a piperacillin-tazobactam prescription
Proportion of patients reaching the target of fT>MIC equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention
Proportion of patients reaching the target of the time the free concentration of the drug remains above the MIC during the dosing interval (i.e. fT\>MIC) equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention
Time frame: At 24 hours of treatment of piperacillin-tazobactam after randomization
Number of days of piperacillin-tazobactam treatment under study
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Evaluate the number of days of piperacillin-tazobactam treatment under study
Time frame: From enrollment to the last dose of the intervention, assessed up to 42 days
Need of escalation to carbapenems antibiotics
Assess if there has been an escalation to carbapenem antibiotics
Time frame: From enrollment to the last dose of the intervention, assessed up to 42 days
Incidence of adverse events attributed to the intervention
Evaluate the incidence of adverse effects attributed to the intervention
Time frame: From enrollment to the last dose of the intervention, assessed up to 42 days
Number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch
Evaluate the number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch, if necessary
Time frame: From enrollment to the last dose of the intervention, assessed up to 42 days