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NCT Number: NCT07593547

Combination vs. Monotherapy for Stenotrophomonas Maltophilia Infections

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.

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Key information

Conditions

Bloodstream Infection Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia - Bacterial Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections S Maltophilia Infections Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Microbiology and Infectious Disease Department, Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location status: Recruiting

Location contact

Sofia de la villa Martinez

CONTACT

[email protected]

003491868453

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: At 30 days

  2. All-cause mortality

    Time frame: At 60 days

Secondary outcomes

  1. Frequency of complications

    Time frame: At 60 days

    need for ICU admission and/or RRT, ECMO, recurrences, or in-hospital readmissions

  2. Frequency of adverse events

    Time frame: At 60 days

Study contacts

Contact information is provided by the study sponsor or research team.

Sofia de la villa Martinez, MD

CONTACT

[email protected]

+3491868453

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria Gregorio Marañón

Other

Registry information

Official study title

Combination vs. Monotherapy for Stenotrophomonas Maltophilia Infections: A Multicentre Study Using Target Trial Emulation

Acronym: EMULATE-Sm

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 18, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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