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NCT Number: NCT05924126

Empiric Antibiotic Treatment for Septic Patients in the Intensive Care Unit

Sepsis is one of the most common causes of ICU admission. About 5-15% of patients admitted to the hospital with an infection will have sepsis, and about 30-40% of them will have septic shock. About 34% of septic patients and about 53% of patients with septic shock will die within 28 days of admission. Broad-spectrum empiric antibiotic treatment (depending on the source of infection and patient risk factors) is one of the cornerstones of sepsis management. According to the recommendations of the surviving sepsis campaign, empiric antibiotic treatment should be given within one hour of the patient's arrival for patients with sepsis or septic shock. Administration of inappropriate antibiotics in the first 24 hours of admission was found in 34% of septic patients in various studies, and administration of inappropriate antibiotics (or when administered in delay) was found to be associated with increased morbidity and mortality.

In this study, we will assess the proportion of patients who were admitted to the ICU due to sepsis or septic shock and received empiric antibiotic treatment which, in retrospect, according to the growth in the cultures later on, was inappropriate. We will also assess the therapeutic results in these patients - mainly significant morbidity and mortality within 28 days, and compare them to the group of patients who received appropriate antibiotic therapy. We would also like to assess what were the possible reasons for inappropriate empiric antibiotic treatment, in order to draw conclusions to reduce the rate of these cases.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients admitted to the general ICU due to sepsis or septic shock between 1/1/20 and 31/12/20

Exclusion criteria

Patients who were admitted due to other non-infectious etiologies

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Treatment and study plan

empiric antibiotic therapy

Other

septic ICU patient given broad spectrum antibiotic therapy

Primary outcomes

  1. Proportion of septic patients who recieved inappropriate empiric antibiotic therapy

    Time frame: January 2020-December 2020

    Proportion of septic patients who recieved inappropriate empiric antibiotic therapy

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

Empiric Antibiotic Treatment for Septic Patients in the Intensive Care Unit: Appropriateness and Therapeutic Outcomes

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2023
Registry last updated
May 8, 2025

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.