Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion
Extended-infusion Piperacillin-Tazobactam Versus Intermittent-Infusion Dosing Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Infections.
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2020
CompletedFirst Submitted
Initial submission to the registry
April 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedMay 20, 2021
May 1, 2021
1.5 years
April 19, 2021
May 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
ICU Length of stay
ICU length of stay, assessed up to 30 days
Mortality
ICU length of stay, assessed up to 30 days
Readmission within 30- days
30 days
Adverse drug events
ICU length of stay, assessed up to 30 days
Study Arms (2)
Piperacillin/Tazobactam Intermittent infusion
OTHER4.5 gm Piperacillin/Tazobactam I.V intermittent over 30 min. every 8 hours.
Piperacillin/Tazobactam Continuous infusion
OTHER4.5 gm Piperacillin/Tazobactam I.V extended infusion over 4 hours every 8 hours.
Interventions
Continuous infusion
Intermittent infusion
Eligibility Criteria
You may qualify if:
- Adults aged 18-74 years
- Expected ICU stay more than 24 hours
You may not qualify if:
- Allergy or potential allergy to the study medications
- Pregnancy
- Patients with CrCl\< 20 ml/min or on dialysis
- Cancer patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cairo University Hospitals
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Teaching assistant
Study Record Dates
First Submitted
April 19, 2021
First Posted
May 20, 2021
Study Start
July 27, 2018
Primary Completion
January 26, 2020
Study Completion
January 26, 2020
Last Updated
May 20, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share