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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04895657

Enrollment

Registered

2021-05-20

Start date

2018-07-27

Completion date

2020-01-26

Last updated

2021-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gram-Negative Infections

Keywords

Antibiotics, Beta-lactams, Continuous administration

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

Interventions

DRUGPiperacillin/Tazobactam Continuous infusion

Continuous infusion

DRUGPiperacillin/Tazobactam Intermittent infusion

Intermittent infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
ICU Length of stay	ICU length of stay, assessed up to 30 days	ICU Length of stay in Days
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026