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

Stenotrophomonas Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04639817
• Other study ID #: BD022382
• Status: Completed
• Start date: August 14, 2020
• Est. completion date: April 27, 2021

Study information

• Verified date: April 2021
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1621
• Est. completion date: April 27, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Stenotrophomonas Infection

Intervention

Drug:
• Levofloxacin
Levofloxacin administration
• trimethoprim-sulfamethoxazole
Trimethoprim-sulfamethoxazole administration

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	Duke University, Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or hospice discharge	Patient died or discharged to hospice	In-hospital
Secondary	Hospital length of stay	Mean hospital length of stay, where mortality will be censored as longest possible length of stay	Single encounter