Septic Patients Admitted to the ICUNCT05924126
Empiric Antibiotic Treatment for Septic Patients in the Intensive Care Unit
An observational study of Septic Patients Admitted to the ICU, run by Meir Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Septic Patients Admitted to the ICU
- What is being tested?
- empiric antibiotic therapy
- How many people
- 155 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2024to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: septic patients admitted to the ICU
Who may be able to join
- 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
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empiric Antibiotic Treatment for Septic Patients in the Intensive Care Unit: Appropriateness and Therapeutic Outcomes
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.
- Conditions
- Septic Patients Admitted to the ICU
- Being tested
- empiric antibiotic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empiric antibiotic therapyOther
septic ICU patient given broad spectrum antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| septic patients who recieved appropriate empiric antibiotics | Not described Receives: Other: empiric antibiotic therapy | |
| septic patients who recieved inappropriate empiric antibiotics | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of septic patients who recieved inappropriate empiric antibiotic therapy
Proportion of septic patients who recieved inappropriate empiric antibiotic therapy
Measured: January 2020-December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Jan 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic Patients Admitted to the ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924126
- Sponsor's protocol ID
- MMC-0155-23
- Status last verified
- Oct 2026
- First submitted
- 20 Jun 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empiric Antibiotic Treatment for Septic Patients in the Intensive Care Unit: Appropriateness and Therapeutic Outcomes
- ClinicalTrials.gov ID
- NCT05924126
- Acronym / sponsor ID
- MMC-0155-23
- Conditions
- Septic Patients Admitted to the ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| septic patients who recieved appropriate empiric antibiotics | – | Other: empiric antibiotic therapy |
| septic patients who recieved inappropriate empiric antibiotics | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- septic patients admitted to the ICU
Key inclusion criteria (3 listed)
- 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
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| empiric antibiotic therapyseptic ICU patient given broad spectrum antibiotic therapy | Other | septic patients who recieved appropriate empiric antibiotics |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Patients Admitted to the ICU, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of septic patients who recieved inappropriate empiric antibiotic therapy (time frame: January 2020-December 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.