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

Completed

• Conditions: Stenotrophomonas Infection
• Interventions: Drug: Levofloxacin; Drug: trimethoprim-sulfamethoxazole

• Registration Number: NCT04639817
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-14
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-23
• Primary Completion: 2021-01-31
• Status Verified: 2021-04
• Study Completion: 2021-04-27
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1621

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Levofloxacin targeted therapy	Levofloxacin	Patients with Stenotrophomonas maltophilia bacteremia or lower respiratory tract infection who received Levofloxacin from day of culture positivity (day 0) through day +7.
TMP/SMX targeted therapy	trimethoprim-sulfamethoxazole	Patients with Stenotrophomonas maltophilia bacteremia or lower respiratory tract infection who received TMP/SMX from day of culture positivity (day 0) through day +7.

Primary Outcome Measures

Name	Time	Method
Death or hospice discharge	In-hospital	Patient died or discharged to hospice

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	Single encounter	Mean hospital length of stay, where mortality will be censored as longest possible length of stay

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States