Alternative Treatment Strategies for Stenotrophomonas Maltophilia Pneumonia

Sponsor
Methodist Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT06112938
Collaborator
(none)
400
1
24
16.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Alternative Treatment Strategies for Stenotrophomonas Maltophilia Pneumonia
Actual Study Start Date :
Jul 21, 2022
Anticipated Primary Completion Date :
Jul 21, 2024
Anticipated Study Completion Date :
Jul 21, 2024

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Clinical outcomes such as ICU LOS [30 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ≥18 years of age

    1. maltophilia isolated on respiratory or blood culture
Exclusion Criteria:
  • Those that do not meet the inclusion criteria outlined in Section 4.1.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Dallas Medical Center Dallas Texas United States 75201

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Mathew Crotty, PharmD, Methodist Dallas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT06112938
Other Study ID Numbers:
  • 034.PHA.2022.A
First Posted:
Nov 2, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2023