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Completed

NCT Number: NCT04895657

Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion

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.

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Key information

Conditions

Gram-Negative Infections

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University Hospitals

Cairo, Egypt

About this study

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 :

  • Kidney functions (Serum creatinine, blood urea nitrogen)
  • Liver functions (ALT, AST, Bil D, Bil T, Albumin)
  • Complete blood count
  • Microbiological Evaluation: Cultures and sensitivity tests from suspected site of infection
  • Clinical signs and symptoms of infection documented by the attending physician on patient's medical record
  • APACHE II Variables

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Piperacillin/Tazobactam Continuous infusion

Drug

Continuous infusion

Other names: Piprataz injection

Piperacillin/Tazobactam Intermittent infusion

Drug

Intermittent infusion

Other names: Piprataz injection

Primary outcomes

  1. Clinical cure

    Time frame: 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.

  2. Total cost

    Time frame: ICU length of stay, assessed up to 30 days

    Cost in Dollars (prices of drugs ,supplies prices, preparation, administration, daily hospital stay cost )

Secondary outcomes

  1. ICU Length of stay

    Time frame: ICU length of stay, assessed up to 30 days

    ICU Length of stay in Days

  2. Mortality

    Time frame: ICU length of stay, assessed up to 30 days

    percentage

  3. Readmission within 30- days

    Time frame: 30 days

    Days

  4. Adverse drug events

    Time frame: ICU length of stay, assessed up to 30 days

    Any adverse event occurring during study drug administration

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Extended-infusion Piperacillin-Tazobactam Versus Intermittent-Infusion Dosing Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Infections.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 20, 2021
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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