Back to resultsExtended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion
Primary Purpose
Gram-Negative Infections
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Piperacillin/Tazobactam Continuous infusion
Piperacillin/Tazobactam Intermittent infusion
Sponsored by
About this trial
This is an interventional treatment trial for Gram-Negative Infections focused on measuring Antibiotics, Beta-lactams, Continuous administration
Eligibility Criteria
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
Sites / Locations
- Cairo University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Piperacillin/Tazobactam Intermittent infusion
Piperacillin/Tazobactam Continuous infusion
Arm Description
4.5 gm Piperacillin/Tazobactam I.V intermittent over 30 min. every 8 hours.
4.5 gm Piperacillin/Tazobactam I.V extended infusion over 4 hours every 8 hours.
Outcomes
Primary Outcome Measures
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.
Total cost
Cost in Dollars (prices of drugs ,supplies prices, preparation, administration, daily hospital stay cost )
Secondary Outcome Measures
ICU Length of stay
ICU Length of stay in Days
Mortality
percentage
Readmission within 30- days
Days
Adverse drug events
Any adverse event occurring during study drug administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04895657
Brief Title
Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion
Official Title
Extended-infusion Piperacillin-Tazobactam Versus Intermittent-Infusion Dosing Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Infections.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 27, 2018 (Actual)
Primary Completion Date
January 26, 2020 (Actual)
Study Completion Date
January 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Negative Infections
Keywords
Antibiotics, Beta-lactams, Continuous administration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Piperacillin/Tazobactam Intermittent infusion
Arm Type
Other
Arm Description
4.5 gm Piperacillin/Tazobactam I.V intermittent over 30 min. every 8 hours.
Arm Title
Piperacillin/Tazobactam Continuous infusion
Arm Type
Other
Arm Description
4.5 gm Piperacillin/Tazobactam I.V extended infusion over 4 hours every 8 hours.
Intervention Type
Drug
Intervention Name(s)
Piperacillin/Tazobactam Continuous infusion
Other Intervention Name(s)
Piprataz injection
Intervention Description
Continuous infusion
Intervention Type
Drug
Intervention Name(s)
Piperacillin/Tazobactam Intermittent infusion
Other Intervention Name(s)
Piprataz injection
Intervention Description
Intermittent infusion
Primary Outcome Measure Information:
Title
Clinical cure
Description
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.
Time Frame
ICU length of stay, assessed up to 30 days
Title
Total cost
Description
Cost in Dollars (prices of drugs ,supplies prices, preparation, administration, daily hospital stay cost )
Time Frame
ICU length of stay, assessed up to 30 days
Secondary Outcome Measure Information:
Title
ICU Length of stay
Description
ICU Length of stay in Days
Time Frame
ICU length of stay, assessed up to 30 days
Title
Mortality
Description
percentage
Time Frame
ICU length of stay, assessed up to 30 days
Title
Readmission within 30- days
Description
Days
Time Frame
30 days
Title
Adverse drug events
Description
Any adverse event occurring during study drug administration
Time Frame
ICU length of stay, assessed up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion
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