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OpenTrials
Completed

NCT Number: NCT06112938

Alternative Treatment Strategies for Stenotrophomonas Maltophilia Pneumonia

Multi center, retrospective chart review of patients admitted to MHS hospitals from April 1, 2017 to March 31, 2022. Patients will be identified through the electronic medical record, and data from those that meet the study inclusion and exclusion criteria will be analyzed. Minimum inhibitory concentration (MIC) data will be interpreted per Clinical & Laboratory Standards Institute (CLSI) standards to determine local patterns of resistance. Multivariable logistic regression will be performed to determine predictors of mortality for S. maltophilia isolates.

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Key information

Conditions

Stenotrophomonas Maltophilia Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75201, United States

About this study

Stenotrophomonas maltophilia is an aerobic, non-fermenting, Gram-negative bacillus recognized by the World Health Organization as one of the leading multi-drug resistant nosocomial pathogens worldwide. The Investigators aim to examine differences in clinical outcomes and failure rates between standard and alternative treatment strategies such as minocycline (or moxifloxacin, ciprofloxacin, ceftazidime) alone or in combination with TMP-SMX, alternative TMP-SMX dosing regimens, or variations in durations of therapy for the treatment of S. maltophilia infections within Methodist Health System (MHS).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥18 years of age
  • S. maltophilia isolated on respiratory or blood culture

Exclusion criteria

  • Those that do not meet the inclusion criteria outlined in Section 4.1.

Treatment and study plan

Antibiotic

Drug

We aim to examine differences in clinical outcomes and failure rates between standard and alternative treatment strategies such as minocycline (or moxifloxacin, ciprofloxacin, ceftazidime) alone or in combination with TMP-SMX, alternative TMP-SMX dosing regimens, or variations in durations of therapy for the treatment of S. maltophilia infections within Methodist Health System (MHS).

Primary outcomes

  1. the difference in clinical failure rates between standard and alternative therapy

    Time frame: 30 days

    defined as meeting any of the following criteria: 1) isolation of S. maltophilia from a subsequently collected culture from the same site of index culture after at least 48 hours of therapy; 2) alteration of monotherapy after at least 48 hours of treatment for either an adverse event or concern for clinical failure; or 3) 30-day in-hospital all-cause mortality.

Secondary outcomes

  1. Clinical outcomes such as ICU LOS

    Time frame: 30 days

    related/attributable mortality, and rates of serious adverse events.

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 2, 2023
Registry last updated
Jul 28, 2025

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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