Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion

Phase 4

Completed

• Conditions: Gram-Negative Infections
• Interventions: Drug: Piperacillin/Tazobactam Intermittent infusion; Drug: Piperacillin/Tazobactam Continuous infusion

• Registration Number: NCT04895657
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study Start: 2018-07-27
• Primary Completion: 2020-01-26
• Study Completion: 2020-01-26
• Study First Submitted: 2021-04-19
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-18
• Last Update Submitted: 2021-05-18
• Study First Posted: 2021-05-20
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Adults aged 18-74 years
• Expected ICU stay more than 24 hours

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Exclusion Criteria

• Allergy or potential allergy to the study medications

  • Pregnancy
  • Patients with CrCl< 20 ml/min or on dialysis
  • Cancer patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Piperacillin/Tazobactam Intermittent infusion	Piperacillin/Tazobactam Intermittent infusion	4.5 gm Piperacillin/Tazobactam I.V intermittent over 30 min. every 8 hours.
Piperacillin/Tazobactam Continuous infusion	Piperacillin/Tazobactam Continuous infusion	4.5 gm Piperacillin/Tazobactam I.V extended infusion over 4 hours every 8 hours.

Primary Outcome Measures

Name	Time	Method
Clinical cure	ICU length of stay, assessed up to 30 days	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	ICU length of stay, assessed up to 30 days	Cost in Dollars (prices of drugs ,supplies prices, preparation, administration, daily hospital stay cost )

Secondary Outcome Measures

Name	Time	Method
Mortality	ICU length of stay, assessed up to 30 days	percentage
Readmission within 30- days	30 days	Days
Adverse drug events	ICU length of stay, assessed up to 30 days	Any adverse event occurring during study drug administration
ICU Length of stay	ICU length of stay, assessed up to 30 days	ICU Length of stay in Days

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt