Combination vs. Monotherapy for Stenotrophomonas Maltophilia Infections (NCT07593547) | Clinical Trial Compass
RecruitingNot Applicable
Combination vs. Monotherapy for Stenotrophomonas Maltophilia Infections
Spain790 participantsStarted 2026-03-06
Plain-language 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. maltophilia infections?
Researchers will compare groups receiving monotherapy and combined therapy to see if there are differences in all-cause 30-day mortality.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients
* S. maltophilia infections
* Different episodes if a new infection ocurred \> 30 days since the index episode
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing combination antibiotic therapy versus monotherapy for Stenotrophomonas maltophilia infections — can you explain what combination versus single-drug treatment looks like in practice, and which approach you'd currently lean toward for my situation outside of a trial?
2Since the trial is listed as Phase NA and is measuring all-cause mortality as its main outcome, does that mean there's still significant uncertainty about which treatment approach is safer or more effective for S. maltophilia, and what does that mean for my care right now?
3S. maltophilia infections can involve the bloodstream or lungs — does my specific type of infection match what this trial is focused on, and would that affect whether it's even worth discussing enrollment with my care team?
4Because S. maltophilia is known for being resistant to many common antibiotics, is there a standard-of-care treatment that's already well-established for my case, or is the uncertainty around treatment exactly why a trial like this exists?
5Given that this trial is actively recruiting, what would my day-to-day treatment and monitoring actually look like if I were to participate, and are there logistical demands — like hospital stays or frequent follow-ups — that I should weigh against my current condition and life circumstances?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All-cause mortality
Timeframe: At 30 days
2
All-cause mortality
Timeframe: At 60 days
Trial details
NCT IDNCT07593547
SponsorInstituto de Investigación Sanitaria Gregorio Marañón