Infections, Obesity and Obesity-related Medical Conditions
Conditions
Keywords
Obesity, Piperacillin-tazobactam, Pharmacodynamics
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.
Interventions
DRUGPiperacillin-tazobactam administered in a prolonged infusion
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.
DRUGPiperacillin-tazobactam administered in a standard infusion
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)
Sponsors
CR-CSSS Champlain-Charles-Le Moyne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adherence to the sampling protocol | At 24 hours of treatment of piperacillin-tazobactam after randomization | 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 |
| Recruitment rate | At the randomization | Proportion of patients meeting the eligibility criteria who consent to the study. |
| Achievement of a prespecified number of patients recruited per month | At the randomization | Achievement of a number of patients recruited per month of 5 to 8 patients |
| Proportion of eligible patients relative to the total population who received a piperacillin-tazobactam for the study period | From the screening period to the enrollment, assessed up to 24 hours after the start of a piperacillin-tazobactam prescription | Proportion of eligible patients relative to the total population who received a piperacilline-tazobactam for the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients reaching the target of fT>MIC equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention | At 24 hours of treatment of piperacillin-tazobactam after randomization | 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 |
| Number of days of piperacillin-tazobactam treatment under study | From enrollment to the last dose of the intervention, assessed up to 42 days | Evaluate the number of days of piperacillin-tazobactam treatment under study |
| Need of escalation to carbapenems antibiotics | From enrollment to the last dose of the intervention, assessed up to 42 days | Assess if there has been an escalation to carbapenem antibiotics |
| Incidence of adverse events attributed to the intervention | From enrollment to the last dose of the intervention, assessed up to 42 days | Evaluate the incidence of adverse effects attributed to the intervention |
| Number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch | From enrollment to the last dose of the intervention, assessed up to 42 days | Evaluate the number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch, if necessary |
Countries
Canada
Outcome results
None listed