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Continuous-infusion of piperacillin/tazobactam over 4 hrs instead of 30-minute intermittent dosage regimen has shown observable outcomes. Our objective is to assess whether continuous infusion of piperacillin/tazobactam is superior in terms of efficacy, safety and cost to the intermittent regimen to treat suspected or proved infections due to gram negative bacteria. The setting is Critical Care Medicine Department at Cairo University Hospitals. Methods A prospective randomized comparative study.
A total of 56 patients were recruited from ICU- Cairo University Hospitals. All adult critically ill patients admitted to Critical Care Medicine Department with suspected or confirmed bacterial infections on admission or during their ICU stay were assessed for inclusion into the study. All patients were subjected to the following: A. Patient's full history: Age, sex ,medical history ,concurrent diseases, concurrent medications
B. Patient evaluation and assessment:
The following were evaluated at baseline and periodically thereafter until day of stopping antibiotic, discharge and/or death :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Piperacillin/Tazobactam Intermittent infusion | Other | 4.5 gm Piperacillin/Tazobactam I.V intermittent over 30 min. every 8 hours. |
|
| Piperacillin/Tazobactam Continuous infusion | Other | 4.5 gm Piperacillin/Tazobactam I.V extended infusion over 4 hours every 8 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piperacillin/Tazobactam Continuous infusion | Drug | Continuous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure | Clinical cure, expressed in percentage, will be considered fulfilled if all the following criteria are met : Cure or improvement of clinical signs and symptoms caused by the infection, normalized WBCs and body temperature. | ICU length of stay, assessed up to 30 days |
| Total cost | Cost in Dollars (prices of drugs ,supplies prices, preparation, administration, daily hospital stay cost ) | ICU length of stay, assessed up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Length of stay | ICU Length of stay in Days | ICU length of stay, assessed up to 30 days |
| Mortality | percentage | ICU length of stay, assessed up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
Allergy or potential allergy to the study medications
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals | Cairo | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2018 | May 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010878 | Piperacillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Piperacillin/Tazobactam Intermittent infusion | Drug | Intermittent infusion |
|
|
| Readmission within 30- days | Days | 30 days |
| Adverse drug events | Any adverse event occurring during study drug administration | ICU length of stay, assessed up to 30 days |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |