Bloodstream InfectionEMULATE-SmNCT07593547
Combination vs. Monotherapy for Stenotrophomonas Maltophilia Infections
An observational study of Bloodstream Infection and Pneumonia - Bacterial, run by Instituto de Investigación Sanitaria Gregorio Marañón at 1 site in Spain.
Trial summary
The goal of this multicentre observational study is to analyse the treatment strategies and the outcomes for patients with S. maltophilia infections using target trial emulation methodology. The main question it aims to answer is: Does combined therapy achieve better results than monotherapy in treating S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodstream Infection, Pneumonia - Bacterial, S Maltophilia Infections
- How many people
- 1,718 participants
- Where
- 1 siteSpain
- Study dates
- 6 Mar 2026to 12 Oct 2026
- How long will I take part?
- 60 Days
- 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: The selection criterion was the isolation of S. maltophilia in consecutive clinical samples from hospitalised adult patients, identified in microbiology laboratories between 2024 and 2025. The investigators first estimated the incidence of the S. maltophilia isolations per 1,000 admissions. Then, differenced episodes of infection defined if the treating physician considered of clinical significance the S. maltophilia isolation. Different infection episodes were considered from 30 days after the index episode.
Who may be able to join
- Adult patients
- S. maltophilia infections
- Different episodes if a new infection ocurred > 30 days since the index episode
Who cannot join
- isolates obtained from patients outside of hospital admission
- microbiological or clinical colonization
- hospitalizations shorter than 72 hours since the time zero
- patients who died in the first 72 hours since the time zero or who were in imminent risk of death
- polymicrobial infections
- receipt of inappropriate therapy after the time of the emulated randomization, defined as the absence of in vitro active antimicrobials or the administration of active antimicrobials for less than 48 hours
- absence of data outcomes
Trial locations and contacts
1 site in 1 country.
Spain1 site
Microbiology and Infectious Disease Department, Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
About this study
Official title: Combination vs. Monotherapy for Stenotrophomonas Maltophilia Infections: A Multicentre Study Using Target Trial Emulation
The goal of this multicentre observational study is to analyse the treatment strategies and the outcomes for patients with S. maltophilia infections using target trial emulation methodology. The main question it aims to answer is:
- Does combined therapy achieve better results than monotherapy in treating S. maltophilia infections?
Researchers will compare groups receiving monotherapy and combined therapy to see if there are differences in all-cause 30-day mortality.
- Keywords
- S. maltophilia, Infection, Mortality, Combined therapy
- Medical subject headings
- Sepsis, Pneumonia, Bacterial, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: At 30 days
All-cause mortality
Measured: At 60 days
Secondary outcomes (2)
Frequency of complications
need for ICU admission and/or RRT, ECMO, recurrences, or in-hospital readmissions
Measured: At 60 days
Frequency of adverse events
Measured: At 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start6 Mar 2026
- Primary completion12 Oct 2026
- Study completion12 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream InfectionStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,718 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Gregorio Marañón
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia De La Villa, Instituto de Investigación Sanitaria Gregorio Marañón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593547
- Sponsor's protocol ID
- MICRO.HGUGM.2025-015
- Acronym
- EMULATE-Sm
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination vs. Monotherapy for Stenotrophomonas Maltophilia Infections: A Multicentre Study Using Target Trial Emulation
- ClinicalTrials.gov ID
- NCT07593547
- Acronym / sponsor ID
- EMULATE-Sm / MICRO.HGUGM.2025-015
- Keywords
- S. maltophilia, Infection, Mortality, Combined therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,718 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria Gregorio MarañónUniversity, hospital or other
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 12 Oct 2026 (actual)
- Study completion
- 12 Oct 2026 (actual)
- First posted
- 18 May 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.
The goal of this multicentre observational study is to analyse the treatment strategies and the outcomes for patients with S. maltophilia infections using target trial emulation methodology. The main question it aims to answer is:
- Does combined therapy achieve better results than monotherapy in treating S. maltophilia infections?
Researchers will compare groups receiving monotherapy and combined therapy to see if there are differences in all-cause 30-day mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 60 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The selection criterion was the isolation of S. maltophilia in consecutive clinical samples from hospitalised adult patients, identified in microbiology laboratories between 2024 and 2025. The investigators first estimated the incidence of the S. maltophilia isolations per 1,000 admissions. Then, differenced episodes of infection defined if the treating physician considered of clinical significance the S. maltophilia isolation. Different infection episodes were considered from 30 days after the index episode.
Key inclusion criteria (3 listed)
- Adult patients
- S. maltophilia infections
- Different episodes if a new infection ocurred > 30 days since the index episode
Key exclusion criteria (7 listed)
- isolates obtained from patients outside of hospital admission
- microbiological or clinical colonization
- hospitalizations shorter than 72 hours since the time zero
- patients who died in the first 72 hours since the time zero or who were in imminent risk of death
- polymicrobial infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: At 30 days
All-cause mortality
Time frame: At 60 days
2 secondary outcomes
Frequency of complications
Time frame: At 60 days
Frequency of adverse events
Time frame: At 60 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 13 Oct 2026.
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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 Bloodstream Infection and Pneumonia - Bacterial, run by Instituto de Investigación Sanitaria Gregorio Marañón at 1 site in Spain.
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 7 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 13 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 Spain. 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?
All-cause mortality (time frame: At 30 days). The study lists 2 primary outcomes in all. 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 13 Oct 2026.