Bloodstream InfectionACT-FASTNCT07491419

The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome (ACT-FAST)

A study testing Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided Stewardship in people with Bloodstream Infection and Gram-Negative Infections, run by Istituto Clinico Humanitas at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Bloodstream Infection, Gram-Negative Infections, Gram-Positive Infections
What is being tested?: Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided Stewardship
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteItaly
Study dates: 19 Mar 2026to 19 Mar 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

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

Who may be able to join

Patients admitted to emergency department or hospitalized for any cause in participating hospitals with clinically suspected BSI and positive blood culture.
At least 18 years of age.

Who cannot join

Have previously taken part in this trial.
Concurrently participating in the active phase of a study considered incompatible.
Patient with severe or terminal disease with life expectancy shorter than 48 h.
Have an existing directive to withhold life-sustaining treatment, in relation to antibiotic use.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michele Bartoletti, MD, PhD contact

+ 39 02 8224 3568

michele.bartoletti@hunimed.eu

Italy1 site, 1 recruiting

Infectious Disease Unit - IRCCS Humanitas Research Hospital
Rozzano, Milan, 20089
Michele Bartoletti, MD, PhD, + 39 02 8224 3568, michele.bartoletti@hunimed.eu
Recruiting

Other trials in Italy

About this study

Official title: The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome: a Randomized Clinical Trial Within an Adaptive Platform Trial for Patients With Bloodstream Infections

The ACT-FAST study aims to compare commercially available Rapid Antimicrobial Susceptibility Testing (R-AST) tools with the current standard of care for patients with Bloodstream Infections (BSI). The primary objective is to evaluate whether "early targeted" antibiotic prescriptions, guided by these rapid tests, can improve antimicrobial stewardship and patient clinical outcomes.

To facilitate the evaluation of various diagnostic tools-including those currently on the market and those emerging in the near future-this study utilizes an adaptive clinical trial platform. This flexible design allows for the continuous assessment of different R-AST technologies within a single master protocol, ensuring that the most effective diagnostic strategies are identified efficiently.

Read the detailed description

ACT-FAST is a multicenter, open-label, randomized, adaptive clinical trial designed as the first domain of a broader adaptive platform. The study evaluates the clinical and stewardship impact of "early targeted" antibiotic therapy guided by Rapid Antimicrobial Susceptibility Testing (R-AST) compared to standard empirical therapy in patients with suspected bloodstream infections (BSI).

The study population consists of patients with positive blood cultures for whom pathogen identification and susceptibility results are still pending. Participants are randomized into one of two diagnostic strategies:

Experimental Arm: Blood cultures are processed using R-AST testing tools to provide rapid phenotypic or genotypic susceptibility data.
Standard of Care (SoC) Arm: Blood cultures are processed according to the standard laboratory diagnostic workflow of the participating center.

In both arms, results are communicated to the treating clinicians, who adjust antibiotic therapy based on their clinical judgment and routine practice. As an adaptive trial, the randomization ratios may be adjusted based on the number of active intervention arms. To ensure scientific rigor, outcome assessors remain blinded to the treatment allocation.

Patients are followed for a total of 28 days to assess clinical outcomes and antimicrobial stewardship objectives. The platform design allows for the integration of additional R-AST tools or interventions through future protocol amendments, ensuring the study remains at the forefront of diagnostic innovation.

Conditions: Bloodstream Infection, Gram-Negative Infections, Gram-Positive Infections, Bacteremia Sepsis
Being tested: Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided Stewardship, Standard of Care (SOC)
Keywords: Blood Stream Infection, Gram-negative Infections, Gram-positive Infections, Bacteremia Sepsis
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided StewardshipDiagnostic test
In patients randomized to the intervention arm, the test under evaluation will be performed by the Humanitas Core Lab on positive blood cultures. The test is expected to provide results in a certain amount of time. The Lab will notify the ID consultant as soon as the test provides the first result (even if partial). The ID physician is expected to revise the antibiotic therapy according to the identified species, guided by the tool.
Standard of Care (SOC)Diagnostic test
Patients will be managed as usual, which typically consists of receiving standard empirical antibiotics, according to the local prescribing policy, continued until the results of the routine standard AST protocol in current use. In any case, both arms have standard microbiology culture and susceptibility testing performed, according to standard laboratory procedures and current guidelines, with results typically available after 48-72 hours from a blood culture positive result (day 3).

Study groups in NCT07491419
Study group	Role	What they receive
Experimental arm	Experimental	Diagnostic approach to blood cultures using rapid microbiological diagnosis testing (R-AST) Receives: Diagnostic Test: Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided Stewardship
Standard of care	Active comparator	Diagnostic approach to blood cultures using the standard method Receives: Diagnostic Test: Standard of Care (SOC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Compare commercially available R-AST testing tools with the current standard of care in BSI patients
The primary objective is to determine if a management strategy based on a R-AST test results shorten the time for randomization to antimicrobial stewardship goals compared to standard care. "Antimicrobial stewardship goals" is defined by the administration of an antimicrobial agent that meets both conditions: i) an antimicrobial agent active against the organism(s) documented at conventional AST on blood culture (in vitro); AND ii) an antimicrobial agent targeted for the pathogen(s) identified, and not excessively broad spectrum
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 202619 Mar 2028

First posted24 Mar 2026
Study start19 Mar 2026
Primary completion19 Mar 2028 (estimated)
Study completion19 Mar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Bloodstream InfectionStudies of the same condition, open and under way.
More trials run by Istituto Clinico HumanitasThe 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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Model description: It is a multi-center, open-label, parallel, adaptive randomized trial. Groups of randomization: * Genotypic Fast AST * Phenotypic AST * Phenotypic + Genotypic AST
Masking: None (open label)
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07491419
Sponsor's protocol ID: ACT-FAST
Acronym: ACT-FAST
Status last verified: Jun 2026
First submitted: 18 Mar 2026
Last updated: 24 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Angus DC, Berry S, Lewis RJ, Al-Beidh F, Arabi Y, van Bentum-Puijk W, Bhimani Z, Bonten M, Broglio K, Brunkhorst F, Cheng AC, Chiche JD, De Jong M, Detry M, Goossens H, Gordon A, Green C, Higgins AM, Hullegie SJ, Kruger P, Lamontagne F, Litton E, Marshall J, McGlothlin A, McGuinness S, Mouncey P, Murthy S, Nichol A, O'Neill GK, Parke R, Parker J, Rohde G, Rowan K, Turner A, Young P, Derde L, McArthur C, Webb SA. The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design. Ann Am Thorac Soc. 2020 Jul;17(7):879-891. doi: 10.1513/AnnalsATS.202003-192SD.
PubMed 32267771
Marquet K, Liesenborgs A, Bergs J, Vleugels A, Claes N. Incidence and outcome of inappropriate in-hospital empiric antibiotics for severe infection: a systematic review and meta-analysis. Crit Care. 2015 Feb 16;19(1):63. doi: 10.1186/s13054-015-0795-y.
PubMed 25888181
Mettler J, Simcock M, Sendi P, Widmer AF, Bingisser R, Battegay M, Fluckiger U, Bassetti S. Empirical use of antibiotics and adjustment of empirical antibiotic therapies in a university hospital: a prospective observational study. BMC Infect Dis. 2007 Mar 26;7:21. doi: 10.1186/1471-2334-7-21.
PubMed 17386104
Friedman ND, Kaye KS, Stout JE, McGarry SA, Trivette SL, Briggs JP, Lamm W, Clark C, MacFarquhar J, Walton AL, Reller LB, Sexton DJ. Health care--associated bloodstream infections in adults: a reason to change the accepted definition of community-acquired infections. Ann Intern Med. 2002 Nov 19;137(10):791-7. doi: 10.7326/0003-4819-137-10-200211190-00007.
PubMed 12435215
Evans 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, Moller MH, 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. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
PubMed 34599691
Proschan M, Evans S. Resist the Temptation of Response-Adaptive Randomization. Clin Infect Dis. 2020 Dec 31;71(11):3002-3004. doi: 10.1093/cid/ciaa334.
PubMed 32222766
Lin J, Bunn V. Comparison of multi-arm multi-stage design and adaptive randomization in platform clinical trials. Contemp Clin Trials. 2017 Mar;54:48-59. doi: 10.1016/j.cct.2017.01.003. Epub 2017 Jan 13.
PubMed 28089763
Pallmann P, Bedding AW, Choodari-Oskooei B, Dimairo M, Flight L, Hampson LV, Holmes J, Mander AP, Odondi L, Sydes MR, Villar SS, Wason JMS, Weir CJ, Wheeler GM, Yap C, Jaki T. Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Med. 2018 Feb 28;16(1):29. doi: 10.1186/s12916-018-1017-7.
PubMed 29490655
Ilges D, Tande AJ, Stevens RW. A Broad Spectrum of Possibilities: Spectrum Scores as a Unifying Metric of Antibiotic Utilization. Clin Infect Dis. 2023 Jul 26;77(2):167-173. doi: 10.1093/cid/ciad189.
PubMed 36999909
Mulatero F, Bonnardel V, Micolaud C. The way forward for fast microbiology. Clin Microbiol Infect. 2011 May;17(5):661-7. doi: 10.1111/j.1469-0691.2011.03520.x.
PubMed 21521410
Pascale R, Corcione S, Bussini L, Pancaldi L, Giacobbe DR, Ambretti S, Lupia T, Costa C, Marchese A, De Rosa FG, Bassetti M, Viscoli C, Bartoletti M, Giannella M, Viale P. Non-fermentative gram-negative bloodstream infection in northern Italy: a multicenter cohort study. BMC Infect Dis. 2021 Aug 12;21(1):806. doi: 10.1186/s12879-021-06496-8.
PubMed 34384380
Ruddel H, Thomas-Ruddel DO, Reinhart K, Bach F, Gerlach H, Lindner M, Marshall JC, Simon P, Weiss M, Bloos F, Schwarzkopf D; MEDUSA study group. Adverse effects of delayed antimicrobial treatment and surgical source control in adults with sepsis: results of a planned secondary analysis of a cluster-randomized controlled trial. Crit Care. 2022 Feb 28;26(1):51. doi: 10.1186/s13054-022-03901-9.
PubMed 35227308
Leone M, Martin C. How to break the vicious circle of antibiotic resistances? Curr Opin Crit Care. 2008 Oct;14(5):587-92. doi: 10.1097/MCC.0b013e32830f1deb.
PubMed 18787454
Bernhard M, Lichtenstern C, Eckmann C, Weigand MA. The early antibiotic therapy in septic patients--milestone or sticking point? Crit Care. 2014 Nov 30;18(6):671. doi: 10.1186/s13054-014-0671-1.
PubMed 25672873
Breijyeh Z, Jubeh B, Karaman R. Resistance of Gram-Negative Bacteria to Current Antibacterial Agents and Approaches to Resolve It. Molecules. 2020 Mar 16;25(6):1340. doi: 10.3390/molecules25061340.
PubMed 32187986

Interested in taking part?

Michele Bartoletti, MD, PhD

+ 39 02 8224 3568

michele.bartoletti@hunimed.eu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Bloodstream Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome: a Randomized Clinical Trial Within an Adaptive Platform Trial for Patients With Bloodstream Infections
ClinicalTrials.gov ID: NCT07491419
Acronym / sponsor ID: ACT-FAST / ACT-FAST
Conditions: Bloodstream Infection, Gram-Negative Infections, Gram-Positive Infections, Bacteremia Sepsis
Keywords: Blood Stream Infection, Gram-negative Infections, Gram-positive Infections, Bacteremia Sepsis
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 400 participants (estimated)
Lead sponsor: Istituto Clinico HumanitasUniversity, hospital or other
Collaborators: BioMérieux
Study start: 19 Mar 2026 (actual)
Primary completion: 19 Mar 2028 (estimated)
Study completion: 19 Mar 2028 (estimated)
First posted: 24 Mar 2026 (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.

Detailed description

Experimental Arm: Blood cultures are processed using R-AST testing tools to provide rapid phenotypic or genotypic susceptibility data.
Standard of Care (SoC) Arm: Blood cultures are processed according to the standard laboratory diagnostic workflow of the participating center.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: It is a multi-center, open-label, parallel, adaptive randomized trial. Groups of randomization: * Genotypic Fast AST * Phenotypic AST * Phenotypic + Genotypic AST

Arm	Type	Receives
Experimental arm	Experimental	Diagnostic Test: Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided StewardshipDiagnostic approach to blood cultures using rapid microbiological diagnosis testing (R-AST)
Standard of care	Active comparator	Diagnostic Test: Standard of Care (SOC)Diagnostic approach to blood cultures using the standard method

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients admitted to emergency department or hospitalized for any cause in participating hospitals with clinically suspected BSI and positive blood culture.
At least 18 years of age.

Key exclusion criteria (4 listed)

Have previously taken part in this trial.
Concurrently participating in the active phase of a study considered incompatible.
Patient with severe or terminal disease with life expectancy shorter than 48 h.
Have an existing directive to withhold life-sustaining treatment, in relation to antibiotic use.

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
Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided StewardshipIn patients randomized to the intervention arm, the test under evaluation will be performed by the Humanitas Core Lab on positive blood cultures. The test is expected to provide results in a certain amount of time. The Lab will notify the ID consultant as soon as the test provides the first result (even if partial). The ID physician is expected to revise the antibiotic therapy according to the identified species, guided by the tool.	Diagnostic test	Experimental arm
Standard of Care (SOC)Patients will be managed as usual, which typically consists of receiving standard empirical antibiotics, according to the local prescribing policy, continued until the results of the routine standard AST protocol in current use. In any case, both arms have standard microbiology culture and susceptibility testing performed, according to standard laboratory procedures and current guidelines, with results typically available after 48-72 hours from a blood culture positive result (day 3).	Diagnostic test	Standard of care

Primary outcome

Compare commercially available R-AST testing tools with the current standard of care in BSI patients
Time frame: 24 hours
The primary objective is to determine if a management strategy based on a R-AST test results shorten the time for randomization to antimicrobial stewardship goals compared to standard care. "Antimicrobial stewardship goals" is defined by the administration of an antimicrobial agent that meets both conditions: i) an antimicrobial agent active against the organism(s) documented at conventional AST on blood culture (in vitro); AND ii) an antimicrobial agent targeted for the pathogen(s) identified, and not excessively broad spectrum

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Background: PubMed 32267771Angus DC, Berry S, Lewis RJ, Al-Beidh F, Arabi Y, van Bentum-Puijk W, Bhimani Z, Bonten M, Broglio K, Brunkhorst F, Cheng AC, Chiche JD, De Jong M, Detry M, Goossens H, Gordon A, Green C, Higgins AM, Hullegie SJ, Kruger P, Lamontagne F, Litton E, Marshall J, McGlothlin A, McGuinness S, Mouncey P, Murthy S, Nichol A, O'Neill GK, Parke R, Parker J, Rohde G, Rowan K, Turner A, Young P, Derde L, McArthur C, Webb SA. The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design. Ann Am Thorac Soc. 2020 Jul;17(7):879-891. doi: 10.1513/AnnalsATS.202003-192SD.
Background: PubMed 25888181Marquet K, Liesenborgs A, Bergs J, Vleugels A, Claes N. Incidence and outcome of inappropriate in-hospital empiric antibiotics for severe infection: a systematic review and meta-analysis. Crit Care. 2015 Feb 16;19(1):63. doi: 10.1186/s13054-015-0795-y.
Background: PubMed 17386104Mettler J, Simcock M, Sendi P, Widmer AF, Bingisser R, Battegay M, Fluckiger U, Bassetti S. Empirical use of antibiotics and adjustment of empirical antibiotic therapies in a university hospital: a prospective observational study. BMC Infect Dis. 2007 Mar 26;7:21. doi: 10.1186/1471-2334-7-21.
Background: PubMed 12435215Friedman ND, Kaye KS, Stout JE, McGarry SA, Trivette SL, Briggs JP, Lamm W, Clark C, MacFarquhar J, Walton AL, Reller LB, Sexton DJ. Health care--associated bloodstream infections in adults: a reason to change the accepted definition of community-acquired infections. Ann Intern Med. 2002 Nov 19;137(10):791-7. doi: 10.7326/0003-4819-137-10-200211190-00007.
Background: PubMed 34599691Evans 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, Moller MH, 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. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
Background: PubMed 32222766Proschan M, Evans S. Resist the Temptation of Response-Adaptive Randomization. Clin Infect Dis. 2020 Dec 31;71(11):3002-3004. doi: 10.1093/cid/ciaa334.
Background: PubMed 28089763Lin J, Bunn V. Comparison of multi-arm multi-stage design and adaptive randomization in platform clinical trials. Contemp Clin Trials. 2017 Mar;54:48-59. doi: 10.1016/j.cct.2017.01.003. Epub 2017 Jan 13.
Background: PubMed 29490655Pallmann P, Bedding AW, Choodari-Oskooei B, Dimairo M, Flight L, Hampson LV, Holmes J, Mander AP, Odondi L, Sydes MR, Villar SS, Wason JMS, Weir CJ, Wheeler GM, Yap C, Jaki T. Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Med. 2018 Feb 28;16(1):29. doi: 10.1186/s12916-018-1017-7.
Background: PubMed 36999909Ilges D, Tande AJ, Stevens RW. A Broad Spectrum of Possibilities: Spectrum Scores as a Unifying Metric of Antibiotic Utilization. Clin Infect Dis. 2023 Jul 26;77(2):167-173. doi: 10.1093/cid/ciad189.
Background: PubMed 21521410Mulatero F, Bonnardel V, Micolaud C. The way forward for fast microbiology. Clin Microbiol Infect. 2011 May;17(5):661-7. doi: 10.1111/j.1469-0691.2011.03520.x.
Background: PubMed 34384380Pascale R, Corcione S, Bussini L, Pancaldi L, Giacobbe DR, Ambretti S, Lupia T, Costa C, Marchese A, De Rosa FG, Bassetti M, Viscoli C, Bartoletti M, Giannella M, Viale P. Non-fermentative gram-negative bloodstream infection in northern Italy: a multicenter cohort study. BMC Infect Dis. 2021 Aug 12;21(1):806. doi: 10.1186/s12879-021-06496-8.
Background: PubMed 35227308Ruddel H, Thomas-Ruddel DO, Reinhart K, Bach F, Gerlach H, Lindner M, Marshall JC, Simon P, Weiss M, Bloos F, Schwarzkopf D; MEDUSA study group. Adverse effects of delayed antimicrobial treatment and surgical source control in adults with sepsis: results of a planned secondary analysis of a cluster-randomized controlled trial. Crit Care. 2022 Feb 28;26(1):51. doi: 10.1186/s13054-022-03901-9.

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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.

Michele Bartoletti, MD, PhD contact

+ 39 02 8224 3568

michele.bartoletti@hunimed.eu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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: looking for participants now, as of the sponsor's last update on 24 Jun 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 Italy. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michele Bartoletti, MD, PhD (+ 39 02 8224 3568, michele.bartoletti@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare commercially available R-AST testing tools with the current standard of care in BSI patients (time frame: 24 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 NCT07491419, which also lists 16 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 Jun 2026.