SepsisIPA-SOSNCT06657625
Impact of the Introduction of a Performance Improvement Program on the Initial Management of Sepsis and Septic Shock in Adults in the Emergency Department: a Before-and-after Study (IPA-SOS)
An observational study of Sepsis and Septic Shock, run by University Hospital, Brest at 1 site in France.
Trial summary
The goal of this observational study is to evaluate if a performance improvement program can improve the initial management of sepsis and septic shock in adults at Brest University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Critical Illness
- What is being tested?
- Sepsis Performance Improvement Program
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2024to 31 Jul 2026
- 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: All patients with blood cultures collected and a SOFA score ≥ 2 presenting to the emergency department of Brest University Hospital, between January 1, 2017, to December 31, 2017 and May 1, 2022, to April 30, 2024.
Who may be able to join
- Major
- Patients with positive blood cultures and a positive SOFA score
- Patients with blood cultures collected, a positive SOFA score, and sepsis/septic shock confirmed by the sepsis team at Brest University Hospital.
- Patients enrolled in a social security scheme
Who cannot join
- Patients under judicial protection (guardianship, curatorship, etc.)
- Refusal to participate
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Introduction of a Performance Improvement Program on the Initial Management of Sepsis and Septic Shock in Adults in the Emergency Department: a Before-and-after Study
The goal of this observational study is to evaluate if a performance improvement program can improve the initial management of sepsis and septic shock in adults at Brest University Hospital. The study will include adult patients with positive blood cultures and a positive SOFA (Sequential Organ Failure Essessment) score, or with blood cultures collected, a positive SOFA score, and sepsis/septic shock confirmed by the sepsis team at Brest University Hospital.
The main questions it aims to answer are:
Read more
- Does the implementation of a performance improvement program increase adherence to the 2021 Surviving Sepsis Campaign (SSC) guidelines?
- Does the program improve patient outcomes, such as 90-day mortality, progression to septic shock, and length of stay in the ICU and hospital?
Researchers will compare patients from two periods : pre-implementation (January 1, 2017 to December 31, 2017) and post-implementation (May 1, 2022 to April 30, 2024), to see if the performance improvement program leads to better compliance with SSC guidelines and improved patient outcomes.
Participants will:
- Have their clinical data (such as blood cultures, SOFA scores, and treatment times) collected and analyzed.
- Be monitored for time to antibiotic therapy, initial fluid resuscitation, and other key treatment interventions following the recognition of sepsis or septic shock.
Read the detailed description
Sepsis and septic shock are conditions with a significant public health impact, yet the incidence of sepsis continues to rise. To improve the management of these conditions, experts recommend implementing performance improvement programs. These recommendations were applied at Brest University Hospital in 2018, including the creation of a "sepsis team" responsible for prevention, education, and providing guidance and advice on sepsis and septic shock. The team consists of infectious disease specialists, emergency physicians, and critical care doctors.
Due to the heterogeneity of such programs worldwide, it is important to assess the effectiveness of the performance improvement program at Brest University Hospital by evaluating adherence to the 2021 Surviving Sepsis Campaign (SSC) guidelines before and after its implementation.
The study will include adult patients with positive blood cultures and a positive SOFA score, or with blood cultures collected, a positive SOFA score, and sepsis/septic shock confirmed by the sepsis team at Brest University Hospital. Two periods : from 01/01/2017 to 31/12/2017 and from 01/05/2022 to 30/04/2024.
The pre- and post-implementation groups will be compared, with the primary outcome being compliance with the 2021 SSC recommendations (antibiotic therapy, hemodynamic management, respiratory support, corticosteroid therapy). Secondary outcomes include time from admission to first physician contact, time from first contact to initiation of antibiotic therapy, time from first contact to first fluid resuscitation, the proportion of sepsis patients progressing to septic shock in the emergency department, length of ICU and hospital stay, 90-day mortality, duration of mechanical ventilation, and changes in SOFA score (at 24 hours, Day 2, and Day 7).
The role of the Initial Orientation Nurse (ION) is integrated into the evaluation criteria. Using a triage grid, sometimes in collaboration with the senior emergency physician or resuscitation physician, the ION determines the optimal time frame for care and the most appropriate treatment pathway. The ION plays a key role in the early recognition of sepsis/septic shock.
The investigators will consider the time from patient evaluation by the ION to assess the speed of activation of the appropriate care pathway and the promptness of sepsis/septic shock management after recognition.
The objective of this study is to evaluate the impact of implementing a performance improvement program on the initial management of sepsis and septic shock in adults in the emergency medicine department of Brest University Hospital, guided by the 2021 Surviving Sepsis Campaign (SSC) guidelines.
- Conditions
- Sepsis, Septic Shock, Critical Illness, Emergency Medicine, Surviving Sepsis Campaign, Sepsis Performance Improvement Program
- Being tested
- Sepsis Performance Improvement Program
- Medical subject headings
- Sepsis, Shock, Septic, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sepsis Performance Improvement ProgramOther
Also called Implementation of a Performance Improvement Program, Performance Improvement Program
Training/awareness for medical and paramedical staff; creation of informational posters; development of an institutional pathway in the emergency department; creation of a protocol ; establishment of a sepsis team with a dedicated contact number.
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation cohort | Patients from January 1, 2017, to December 31, 2017, before the implementation of the performance improvement program. | |
| Post-implementation cohort | Patients from May 1, 2022, to April 30, 2024, after the implementation of the performance improvement program. Receives: Other: Sepsis Performance Improvement Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay from Initial Orientation Nurse (ION) to initiation of antibiotic therapy
Delay from Initial Orientation Nurse (ION) to initiation of antibiotic therapy in minutes.
From ION assessment to the first antibiotic administration in the emergency departement.
Measured: Up to 6 hours
Secondary outcomes (10)
Quality of selected antibiotic therapy
The investigators use modified Gyssen score to evaluate the quality of antibiotic therapy.
It's a qualitative score; the response is whether the antibiotic is adapted or not.
At the time of the administration of the first dose of antibiotic in the emergency departement.
Measured: Up to 6hours
Delay from Initial Orientation Nurse (ION) to initial fluid resuscitation
Delay from Initial Orientation Nurse (ION) to initial fluid resuscitation in minutes.
From ION assessment to the first fluid administration in the emergency departement.
Measured: Up to 6 hours
Quality of fluid resuscitation
Quality of fluid resuscitation is defined as a minimum of 30 mL/kg within 3 hours using crystalloid solutions, with a target mean arterial pressure (MAP) of 65 mmHg.
From ION assessment, to 3hours in the emergency departement.
Measured: Up to 3 hours
Quality of oxygen therapy
Quality of oxygen therapy is defined as maintaining an SpO2 target of 94-96%, or 88-92% if the patient has chronic respiratory failure.
At the ION, at 3 hours, and at 6 hours in the emergency department.
Measured: Up to 6 hours
Proportion of sepsis patients progressing to septic shock in the emergency department
Progression of sepsis to septic shock is defined by the necessity for the administration of vasopressors to achieve a mean arterial pressure (MAP) of 65 mmHg after 3 hours in the emergency department.
Measured: Up to 6 hours
Duration of hospitalization in the ICU and hospital, and length of stay in the emergency department
Duration of hospitalization in the ICU and hospital in days; and length of stay in the emergency department in hours.
Measured: Through study completion, an average of 6 months
Duration of mechanical ventilation
Duration of mechanical ventilation is defined as the cumulative time of intubation (IOT) with invasive ventilation (IV) in days during hospitalization in the ICU following initial care in emergency departement.
Measured: Through study completion, an average of 6 months
Changes in the SOFA score
Calculation of the SOFA score. At ION in emergency departement, 24 hours, Day 2, and Day 7. The SOFA score is out of 24, and it is considered positive from 2 points onwards. The higher the score, the greater the severity.
Measured: Up to day 7
28-day mortality
Death within 28 days of administrative admission.
Measured: Up to days 28
90-day mortality
Death within 90 days of administrative admission.
Measured: Up to days 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Aug 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657625
- Sponsor's protocol ID
- 29BRC24.0223 - IPA-SOS
- Acronym
- IPA-SOS
- Status last verified
- Jul 2024
- First submitted
- 14 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Rezig S, Branthome S, Basset A, Helies R, Fiore C, Bailly P, et al. Une "Sepsis Team" est elle indispensable dans chaque hopital ? Médecine Mal Infect. 1 juin 2019;49:S55-6.
Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.
PubMed 31954465Damiani E, Donati A, Serafini G, Rinaldi L, Adrario E, Pelaia P, Busani S, Girardis M. Effect of performance improvement programs on compliance with sepsis bundles and mortality: a systematic review and meta-analysis of observational studies. PLoS One. 2015 May 6;10(5):e0125827. doi: 10.1371/journal.pone.0125827. eCollection 2015.
PubMed 25946168Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.
PubMed 34605781Chiu C, Legrand M. Epidemiology of sepsis and septic shock. Curr Opin Anaesthesiol. 2021 Apr 1;34(2):71-76. doi: 10.1097/ACO.0000000000000958.
PubMed 33492864Schinkel M, Holleman F, Vleghels R, Brugman K, Ridderikhof ML, Dzelili M, Nanayakkara PWB, Wiersinga WJ. The impact of a sepsis performance improvement program in the emergency department: a before-after intervention study. Infection. 2023 Aug;51(4):945-954. doi: 10.1007/s15010-022-01957-x. Epub 2022 Nov 17.
PubMed 36394818
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Introduction of a Performance Improvement Program on the Initial Management of Sepsis and Septic Shock in Adults in the Emergency Department: a Before-and-after Study
- ClinicalTrials.gov ID
- NCT06657625
- Acronym / sponsor ID
- IPA-SOS / 29BRC24.0223 - IPA-SOS
- Conditions
- Sepsis, Septic Shock, Critical Illness, Emergency Medicine, Surviving Sepsis Campaign, Sepsis Performance Improvement Program
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Oct 2024 (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.
The goal of this observational study is to evaluate if a performance improvement program can improve the initial management of sepsis and septic shock in adults at Brest University Hospital. The study will include adult patients with positive blood cultures and a positive SOFA (Sequential Organ Failure Essessment) score, or with blood cultures collected, a positive SOFA score, and sepsis/septic shock confirmed by the sepsis team at Brest University Hospital.
The main questions it aims to answer are:
- Does the implementation of a performance improvement program increase adherence to the 2021 Surviving Sepsis Campaign (SSC) guidelines?
- Does the program improve patient outcomes, such as 90-day mortality, progression to septic shock, and length of stay in the ICU and hospital?
Researchers will compare patients from two periods : pre-implementation (January 1, 2017 to December 31, 2017) and post-implementation (May 1, 2022 to April 30, 2024), to see if the performance improvement program leads to better compliance with SSC guidelines and improved patient outcomes.
Participants will:
- Have their clinical data (such as blood cultures, SOFA scores, and treatment times) collected and analyzed.
- Be monitored for time to antibiotic therapy, initial fluid resuscitation, and other key treatment interventions following the recognition of sepsis or septic shock.
Detailed description
Sepsis and septic shock are conditions with a significant public health impact, yet the incidence of sepsis continues to rise. To improve the management of these conditions, experts recommend implementing performance improvement programs. These recommendations were applied at Brest University Hospital in 2018, including the creation of a "sepsis team" responsible for prevention, education, and providing guidance and advice on sepsis and septic shock. The team consists of infectious disease specialists, emergency physicians, and critical care doctors.
Due to the heterogeneity of such programs worldwide, it is important to assess the effectiveness of the performance improvement program at Brest University Hospital by evaluating adherence to the 2021 Surviving Sepsis Campaign (SSC) guidelines before and after its implementation.
The study will include adult patients with positive blood cultures and a positive SOFA score, or with blood cultures collected, a positive SOFA score, and sepsis/septic shock confirmed by the sepsis team at Brest University Hospital. Two periods : from 01/01/2017 to 31/12/2017 and from 01/05/2022 to 30/04/2024.
The pre- and post-implementation groups will be compared, with the primary outcome being compliance with the 2021 SSC recommendations (antibiotic therapy, hemodynamic management, respiratory support, corticosteroid therapy). Secondary outcomes include time from admission to first physician contact, time from first contact to initiation of antibiotic therapy, time from first contact to first fluid resuscitation, the proportion of sepsis patients progressing to septic shock in the emergency department, length of ICU and hospital stay, 90-day mortality, duration of mechanical ventilation, and changes in SOFA score (at 24 hours, Day 2, and Day 7).
The role of the Initial Orientation Nurse (ION) is integrated into the evaluation criteria. Using a triage grid, sometimes in collaboration with the senior emergency physician or resuscitation physician, the ION determines the optimal time frame for care and the most appropriate treatment pathway. The ION plays a key role in the early recognition of sepsis/septic shock.
The investigators will consider the time from patient evaluation by the ION to assess the speed of activation of the appropriate care pathway and the promptness of sepsis/septic shock management after recognition.
The objective of this study is to evaluate the impact of implementing a performance improvement program on the initial management of sepsis and septic shock in adults in the emergency medicine department of Brest University Hospital, guided by the 2021 Surviving Sepsis Campaign (SSC) guidelines.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation cohort | – | –Patients from January 1, 2017, to December 31, 2017, before the implementation of the performance improvement program. |
| Post-implementation cohort | – | Other: Sepsis Performance Improvement ProgramPatients from May 1, 2022, to April 30, 2024, after the implementation of the performance improvement program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with blood cultures collected and a SOFA score ≥ 2 presenting to the emergency department of Brest University Hospital, between January 1, 2017, to December 31, 2017 and May 1, 2022, to April 30, 2024.
Key inclusion criteria (4 listed)
- Major
- Patients with positive blood cultures and a positive SOFA score
- Patients with blood cultures collected, a positive SOFA score, and sepsis/septic shock confirmed by the sepsis team at Brest University Hospital.
- Patients enrolled in a social security scheme
Key exclusion criteria (3 listed)
- Patients under judicial protection (guardianship, curatorship, etc.)
- Refusal to participate
- Pregnant patients
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 |
|---|---|---|
| Sepsis Performance Improvement ProgramAlso: Implementation of a Performance Improvement Program, Performance Improvement ProgramTraining/awareness for medical and paramedical staff; creation of informational posters; development of an institutional pathway in the emergency department; creation of a protocol ; establishment of a sepsis team with a dedicated contact number. | Other | Post-implementation cohort |
Primary outcome
Delay from Initial Orientation Nurse (ION) to initiation of antibiotic therapy
Time frame: Up to 6 hours
Delay from Initial Orientation Nurse (ION) to initiation of antibiotic therapy in minutes. From ION assessment to the first antibiotic administration in the emergency departement.
10 secondary outcomes
Quality of selected antibiotic therapy
Time frame: Up to 6hours
Delay from Initial Orientation Nurse (ION) to initial fluid resuscitation
Time frame: Up to 6 hours
Quality of fluid resuscitation
Time frame: Up to 3 hours
Quality of oxygen therapy
Time frame: Up to 6 hours
Proportion of sepsis patients progressing to septic shock in the emergency department
Time frame: Up to 6 hours
Duration of hospitalization in the ICU and hospital, and length of stay in the emergency department
Time frame: Through study completion, an average of 6 months
Duration of mechanical ventilation
Time frame: Through study completion, an average of 6 months
Changes in the SOFA score
Time frame: Up to day 7
28-day mortality
Time frame: Up to days 28
90-day mortality
Time frame: Up to days 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- BackgroundRezig S, Branthome S, Basset A, Helies R, Fiore C, Bailly P, et al. Une "Sepsis Team" est elle indispensable dans chaque hopital ? Médecine Mal Infect. 1 juin 2019;49:S55-6.
- Background: PubMed 31954465Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.
- Background: PubMed 25946168Damiani E, Donati A, Serafini G, Rinaldi L, Adrario E, Pelaia P, Busani S, Girardis M. Effect of performance improvement programs on compliance with sepsis bundles and mortality: a systematic review and meta-analysis of observational studies. PLoS One. 2015 May 6;10(5):e0125827. doi: 10.1371/journal.pone.0125827. eCollection 2015.
- Background: PubMed 34605781Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.
- Background: PubMed 33492864Chiu C, Legrand M. Epidemiology of sepsis and septic shock. Curr Opin Anaesthesiol. 2021 Apr 1;34(2):71-76. doi: 10.1097/ACO.0000000000000958.
- Background: PubMed 36394818Schinkel M, Holleman F, Vleghels R, Brugman K, Ridderikhof ML, Dzelili M, Nanayakkara PWB, Wiersinga WJ. The impact of a sepsis performance improvement program in the emergency department: a before-after intervention study. Infection. 2023 Aug;51(4):945-954. doi: 10.1007/s15010-022-01957-x. Epub 2022 Nov 17.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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 Sepsis and Septic Shock, run by University Hospital, Brest 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Oct 2024. 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?
Results are not available in the source record.
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?
Delay from Initial Orientation Nurse (ION) to initiation of antibiotic therapy (time frame: Up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06657625, which also lists 6 linked publications.
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 24 Oct 2024.