Clinical trial NCT06690905: Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population with Obesity
Official title: Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population with Obesity: an Open Randomized Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infections
Obesity and Obesity-related Medical Conditions
Keywords: Obesity
Piperacillin-tazobactam
Pharmacodynamics
Lead sponsor: CR-CSSS Champlain-Charles-Le Moyne
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adults (18 years and older)
* Patients hospitalized at Hôpital Charles-Le Moyne
* Obesity (as defined by a body mass index of ≥ 30 kg/m\^2)
* Piperacillin-tazobactam prescription initiated within last 24 hours
* Planned duration of piperacillin-tazobactam of 24 hours or more

Exclusion Criteria:

* Documented allergy to beta-lactams of the penicillin class
* Patients with renal replacement therapy (hemodialysis, peritoneal dialysis, continuous venovenous hemodiafiltration)
* Pregnancy
* History of seizures or epilepsy, active seizures or epilepsy treated with antiepileptic drug therapy
* Patients on prolonged intermittent infusion or continuous infusion of piperacillin-tazobactam before randomization

Primary outcomes:
measure: Rate of adherence to the sampling protocol
timeFrame: At 24 hours of treatment of piperacillin-tazobactam after randomization
measure: Recruitment rate
timeFrame: At the randomization
measure: Achievement of a prespecified number of patients recruited per month
timeFrame: At the randomization
measure: Proportion of eligible patients relative to the total population who received a piperacillin-tazobactam for the study period
timeFrame: From the screening period to the enrollment, assessed up to 24 hours after the start of a piperacillin-tazobactam prescription
Secondary outcomes:
measure: Proportion of patients reaching the target of fT>MIC equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention
timeFrame: At 24 hours of treatment of piperacillin-tazobactam after randomization
measure: Number of days of piperacillin-tazobactam treatment under study
timeFrame: From enrollment to the last dose of the intervention, assessed up to 42 days
measure: Need of escalation to carbapenems antibiotics
timeFrame: From enrollment to the last dose of the intervention, assessed up to 42 days
measure: Incidence of adverse events attributed to the intervention
timeFrame: From enrollment to the last dose of the intervention, assessed up to 42 days
measure: Number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch
timeFrame: From enrollment to the last dose of the intervention, assessed up to 42 days
Other outcomes:
Locations:
city: Greenfield Park
country: Canada
facility: Hôpital Charles- Le Moyne
state: Quebec
Study officials:
References: