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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Piperacillin-tazobactam administered in a prolonged infusion | Experimental | Piperacillin-tazobactam dose will be administered over 3 hours for piperacillin-tazobactam dosages every 6 hours or over 4 hours for piperacillin-tazobactam dosages every 8 hours. |
|
| Piperacillin-tazobactam administered in a standard infusion | Active Comparator | Piperacillin-tazobactam dose will be administered over 30 minutes for every piperacilline-tazobactam administered in the study (as instructed by the drug's monograph) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piperacillin-tazobactam administered in a prolonged infusion | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 24 hours of treatment of piperacillin-tazobactam after randomization |
| Recruitment rate | Proportion of patients meeting the eligibility criteria who consent to the study. | 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 | 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 | From the screening period to the enrollment, assessed up to 24 hours after the start of a piperacillin-tazobactam prescription |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 24 hours of treatment of piperacillin-tazobactam after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Charles- Le Moyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
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| Piperacillin-tazobactam administered in a standard infusion | Drug | 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) |
|
| Number of days of piperacillin-tazobactam treatment under study | Evaluate the number of days of piperacillin-tazobactam treatment under study | 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 | 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 | 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 | From enrollment to the last dose of the intervention, assessed up to 42 days |
| ID | Term |
|---|---|
| D007239 | Infections |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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