Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-30 @ 8:09 PM
Study NCT ID:
NCT04895657
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2021-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Extended-infusion Piperacillin-Tazobactam Versus Intermittent-Infusion Dosing Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Infections.
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 :
1. Kidney functions (Serum creatinine, blood urea nitrogen)
2. Liver functions (ALT, AST, Bil D, Bil T, Albumin)
3. Complete blood count
4. Microbiological Evaluation: Cultures and sensitivity tests from suspected site of infection
5. Clinical signs and symptoms of infection documented by the attending physician on patient's medical record
6. APACHE II Variables
B. Patient evaluation and assessment:
The following were evaluated at baseline and periodically thereafter until day of stopping antibiotic, discharge and/or death :
1. Kidney functions (Serum creatinine, blood urea nitrogen)
2. Liver functions (ALT, AST, Bil D, Bil T, Albumin)
3. Complete blood count
4. Microbiological Evaluation: Cultures and sensitivity tests from suspected site of infection
5. Clinical signs and symptoms of infection documented by the attending physician on patient's medical record
6. APACHE II Variables
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: