Alternative Treatment Strategies for Stenotrophomonas Maltophilia Pneumonia

NCT06112938 | Completed

• 1 other identifier: 034.PHA.2022.A
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Stenotrophomonas Maltophilia Infection

Outcome Measures

Primary Outcomes (1)

• the difference in clinical failure rates between standard and alternative therapy

  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.

  30 days

Secondary Outcomes (1)

• Clinical outcomes such as ICU LOS

  30 days

Interventions

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).

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

This is a retrospective chart review study limited to only patients meeting inclusion and exclusion criteria. We plan to conduct the retrospective chart review of all patients identified during the study period that meet the inclusion and exclusion criteria.

You may qualify if:

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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75201, United States

Location

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mathew Crotty, PharmD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 2, 2023
• Study Start: July 21, 2022
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)