SepsisNCT05140213
A STUDY BEFORE/AFTER THE IMPLEMENTATION OF AN ANTI-INFECTIOUS PRESCRIPTION AID
An observational study of Sepsis and Septic Shock, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Anti-infective strategy is a major public health problem. This is a before-and-after study of an anti-infectious prescription tool with a comparison of mortality at 30 days (then 3 and 6 months) between the two inclusion phases of 6 months each. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Anti-infectious prescription support tool
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 371 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2020to 30 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major patients with severe sepsis in the Montpellier emergency department
Who may be able to join
- Major patients
- Sepsis or septic shock
- Oral consent
Who cannot join
- minor patients
- death before antibiotherapy
- care limitations
- pre-hospital antibiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF 30-DAY MORTALITY AFTER A VISIT TO THE LAPEYRONIE ADULT EMERGENCY DEPARTMENT OF THE CHU MONTPELLIER FOR SEPSIS OR SEPTIC SHOCK
Anti-infective strategy is a major public health problem. This is a before-and-after study of an anti-infectious prescription tool with a comparison of mortality at 30 days (then 3 and 6 months) between the two inclusion phases of 6 months each.
- Conditions
- Sepsis, Septic Shock
- Being tested
- Anti-infectious prescription support tool
- Keywords
- Adult patients, Probabilistic antibiotic therapy to be initiated
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-infectious prescription support toolDevice
implementation of a pocket notebook with current anti-infectious recommendations in the emergency department Patients were kept under surveillance for at least one hour before discharge.
Patients were discharged home with a 7 day supply of acetaminophen 1000 mg orally every 6 h, ketoprofen 100 mg, orally twice a day, and muscle relaxant as needed. Patients were instructed to take tramadol 50 mg, orally every 6h as needed for low back pain, in case of insufficient relief.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Before | "Before" phase including 186 patients patients included before the implementation of the prescription support tool Receives: Device: Anti-infectious prescription support tool | |
| Group 2 : After | "After" phase including 185 patients patients included after the implementation of the prescription support tool Receives: Device: Anti-infectious prescription support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of patient 30-day mortality
patient survival at 30 days
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start12 Dec 2020
- Primary completion12 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hamza GHOMRANI, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140213
- Sponsor's protocol ID
- RECHMPL21_0685
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF 30-DAY MORTALITY AFTER A VISIT TO THE LAPEYRONIE ADULT EMERGENCY DEPARTMENT OF THE CHU MONTPELLIER FOR SEPSIS OR SEPTIC SHOCK
- ClinicalTrials.gov ID
- NCT05140213
- Acronym / sponsor ID
- RECHMPL21_0685
- Conditions
- Sepsis, Septic Shock
- Keywords
- Adult patients, Probabilistic antibiotic therapy to be initiated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 1 Dec 2021 (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.
Anti-infective strategy is a major public health problem. This is a before-and-after study of an anti-infectious prescription tool with a comparison of mortality at 30 days (then 3 and 6 months) between the two inclusion phases of 6 months each.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Before | – | Device: Anti-infectious prescription support tool"Before" phase including 186 patients patients included before the implementation of the prescription support tool |
| Group 2 : After | – | Device: Anti-infectious prescription support tool"After" phase including 185 patients patients included after the implementation of the prescription support tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients with severe sepsis in the Montpellier emergency department
Key inclusion criteria (3 listed)
- Major patients
- Sepsis or septic shock
- Oral consent
Key exclusion criteria (4 listed)
- minor patients
- death before antibiotherapy
- care limitations
- pre-hospital antibiotherapy
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 |
|---|---|---|
| Anti-infectious prescription support toolimplementation of a pocket notebook with current anti-infectious recommendations in the emergency department Patients were kept under surveillance for at least one hour before discharge. Patients were discharged home with a 7 day supply of acetaminophen 1000 mg orally every 6 h, ketoprofen 100 mg, orally twice a day, and muscle relaxant as needed. Patients were instructed to take tramadol 50 mg, orally every 6h as needed for low back pain, in case of insufficient relief. | Device | Group 1 : Before, Group 2 : After |
Primary outcome
Numbers of patient 30-day mortality
Time frame: 30 day
patient survival at 30 days
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 23 Dec 2021.
- Individual participant dataSharing planned: Undecided. NC
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Septic Shock
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.
Hamza GHOMRANI, MD study director
University Hospital, Montpellier
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 Sepsis and Septic Shock, run by University Hospital, Montpellier at 1 site in France.
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 4 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 23 Dec 2021. 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 France. 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?
Numbers of patient 30-day mortality (time frame: 30 day). 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 23 Dec 2021.