Combination vs. Monotherapy for Stenotrophomonas Maltophilia Infections (EMULATE-Sm)

May 11, 2026 updated by: Sofia De La Villa, Instituto de Investigación Sanitaria Gregorio Marañón

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

790

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28007
        • Microbiology and Infectious Disease Department, Hospital General Universitario Gregorio Marañón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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. We first estimated the incidence of the S. maltophilia isolations per 1,000 admissions. Then, we 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: At 30 days
At 30 days
All-cause mortality
Time Frame: At 60 days
At 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of complications
Time Frame: At 60 days
need for ICU admission and/or RRT, ECMO, recurrences, or in-hospital readmissions
At 60 days
Frequency of adverse events
Time Frame: At 60 days
At 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria Gregorio Marañón

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MICRO.HGUGM.2025-015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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