Trimethoprim-Sulfamethoxazole vs Levofloxacin as Targeted Therapy for Stenotrophomonas Maltophilia Infections: a Retrospective Cohort Study

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Completed

CT.gov ID

NCT04639817

Collaborator

Duke University (Other), Emory University (Other)

1,621

Enrollment

Location

8.4

Actual Duration (Months)

192.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study seeks to compare mortality outcomes of levofloxacin and trimethoprim-sulfamethoxazole treated patients who have Stenotrophomonas maltophilia blood stream or lower respiratory tract infections by retrospectively analyzing a propensity-matched cohort from a large dataset of electronic health record data.

Condition or Disease	Intervention/Treatment	Phase
Stenotrophomonas Infection	Drug: Levofloxacin Drug: trimethoprim-sulfamethoxazole

Study Design

Study Type:

Observational

Actual Enrollment :

1621 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Trimethoprim-Sulfamethoxazole or Levofloxacin? A Retrospective Cohort Study of Targeted Therapy for Stenotrophomonas Maltophilia Blood Stream and Lower Respiratory Tract Infections

Actual Study Start Date :

Aug 14, 2020

Actual Primary Completion Date :

Jan 31, 2021

Actual Study Completion Date :

Apr 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Levofloxacin targeted therapy Patients with Stenotrophomonas maltophilia bacteremia or lower respiratory tract infection who received Levofloxacin from day of culture positivity (day 0) through day +7.	Drug: Levofloxacin Levofloxacin administration
TMP/SMX targeted therapy Patients with Stenotrophomonas maltophilia bacteremia or lower respiratory tract infection who received TMP/SMX from day of culture positivity (day 0) through day +7.	Drug: trimethoprim-sulfamethoxazole Trimethoprim-sulfamethoxazole administration Other Names: TMP/SMX

Arm

Intervention/Treatment

Levofloxacin targeted therapy

Patients with Stenotrophomonas maltophilia bacteremia or lower respiratory tract infection who received Levofloxacin from day of culture positivity (day 0) through day +7.

Drug: Levofloxacin

Levofloxacin administration

TMP/SMX targeted therapy

Patients with Stenotrophomonas maltophilia bacteremia or lower respiratory tract infection who received TMP/SMX from day of culture positivity (day 0) through day +7.

Drug: trimethoprim-sulfamethoxazole

Trimethoprim-sulfamethoxazole administration

Other Names:

TMP/SMX

Outcome Measures

Primary Outcome Measures

Death or hospice discharge [In-hospital]
Patient died or discharged to hospice

Secondary Outcome Measures

Hospital length of stay [Single encounter]
Mean hospital length of stay, where mortality will be censored as longest possible length of stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age and older
Stenotrophomonas maltophilia culture positive from blood or the following specified respiratory tract sites: sputum, tracheal aspirate, bronchoalveolar lavage and protected bronchial brush washings
Received either levofloxacin or TMP/SMX targeted therapy
Those patients that received empiric therapy with a consistent medication (for example, levofloxacin empirically in the levofloxacin targeted therapy cohort) were included

Exclusion Criteria:

Received antimicrobial other than TMP/SMX and levofloxacin, with known activity against Stenotrophomonas maltophilia (the list of antimicrobials that fit this exclusion criteria is: erythromycin, moxifloxacin, ciprofloxacin, minocycline, tigecycline, doxycycline, eravacycline, ceftazidime, cefepime, ticarcillin-clavulanate, cefiderocol, colistin, and chloramphenicol)
Received inconsistent empiric therapy (for example, levofloxacin empirically in the TMP/SMX targeted therapy cohort) will be excluded from analysis
Cystic fibrosis code present
Organism resistant to therapy received