Combination vs. Monotherapy for Stenotrophomonas Maltophilia Infections

NCT07593547 | Recruiting

• 1 other identifier: MICRO.HGUGM.2025-015
• Study Type: observational
• Target: 790
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bloodstream Infection; Pneumonia - Bacterial; S Maltophilia Infections

Keywords

S. maltophilia; Infection; Mortality; Combined therapy

Outcome Measures

Primary Outcomes (2)

• All-cause mortality

  At 30 days

• All-cause mortality

  At 60 days

Secondary Outcomes (2)

• Frequency of complications

  At 60 days

• Frequency of adverse events

  At 60 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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. 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.

You may qualify if:

• Adult patients
• S. maltophilia infections
• Different episodes if a new infection ocurred \> 30 days since the index episode

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Gregorio Marañón: lead

Study Sites (1)

Microbiology and Infectious Disease Department, Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

MeSH Terms

Conditions

Sepsis; Pneumonia, Bacterial; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sofia de la villa Martinez, MD

CONTACT

+3491868453; sofiadela.villa@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-05

Locations

ES (1)