Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion

Study Overview
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Brief Summary
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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.

Detailed Description
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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 : Kidney functions (Serum creatinine, blood urea nitrogen) Liver functions (ALT, AST, Bil D, Bil T, Albumin) Complete blood count Microbiological Evaluation: Cultures and sensitivity tests from suspected site of infection Clinical signs and symptoms of infection documented by the attending physician on patient's medical record APACHE II Variables

Official Title
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Extended-infusion Piperacillin-Tazobactam Versus Intermittent-Infusion Dosing Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Infections.

Conditions
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Gram-Negative Infections

Intervention / Treatment
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* Drug: Piperacillin/Tazobactam Continuous infusion
* Drug: Piperacillin/Tazobactam Intermittent infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18-74 years Expected ICU stay more than 24 hours Exclusion Criteria: Allergy or potential allergy to the study medications Pregnancy Patients with CrCl< 20 ml/min or on dialysis Cancer patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Piperacillin/Tazobactam Intermittent infusion<br>4.5 gm Piperacillin/Tazobactam I.V intermittent over 30 min. every 8 hours. | Drug: Piperacillin/Tazobactam Intermittent infusion<br>* Intermittent infusion<br>* Other names: Piprataz injection;|
| Other: Piperacillin/Tazobactam Continuous infusion<br>4.5 gm Piperacillin/Tazobactam I.V extended infusion over 4 hours every 8 hours. | Drug: Piperacillin/Tazobactam Continuous infusion<br>* Continuous infusion<br>* Other names: Piprataz injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotics, Beta-lactams, Continuous administration