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.

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.

Study Overview

• Status: Completed
• Conditions: Gram-Negative Infections
• Intervention / Treatment: Drug: Piperacillin/Tazobactam Intermittent infusion; Drug: Piperacillin/Tazobactam Continuous infusion

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

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Piperacillin/Tazobactam Intermittent infusion; 4.5 gm Piperacillin/Tazobactam I.V intermittent over 30 min. every 8 hours.	Drug: Piperacillin/Tazobactam Intermittent infusion; Intermittent infusion; Other Names: Piprataz injection
OTHER: Piperacillin/Tazobactam Continuous infusion; 4.5 gm Piperacillin/Tazobactam I.V extended infusion over 4 hours every 8 hours.	Drug: Piperacillin/Tazobactam Continuous infusion; Continuous infusion; Other Names: Piprataz injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 27, 2018
• Primary Completion (ACTUAL): January 26, 2020
• Study Completion (ACTUAL): January 26, 2020

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (ACTUAL): May 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Antibiotics; Beta-lactams; Continuous administration
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Piperacillin; Tazobactam; Piperacillin, Tazobactam Drug Combination
• Other Study ID Numbers: 198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No