Alternative Treatment Strategies for Stenotrophomonas Maltophilia Pneumonia

Recruiting

• Conditions: Stenotrophomonas Maltophilia Infection

• Registration Number: NCT06112938
• Lead Sponsor: Methodist Health System

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2022-07-21
• Study First Submitted: 2022-10-21
• Status Verified: 2023-07
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study First Posted: 2023-11-02
• Last Update Posted: 2023-11-02
• Primary Completion: 2024-07-21
• Study Completion: 2024-07-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the difference in clinical failure rates between standard and alternative therapy	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 Outcome Measures

Name	Time	Method
Clinical outcomes such as ICU LOS	30 days	related/attributable mortality, and rates of serious adverse events.

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States