Skip to main content
OpenTrials
Completed

NCT Number: NCT04639817

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stenotrophomonas Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levofloxacin

Drug

Levofloxacin administration

Trimethoprim-sulfamethoxazole

Drug

Trimethoprim-sulfamethoxazole administration

Other names: TMP/SMX

Primary outcomes

  1. Death or hospice discharge

    Time frame: In-hospital

    Patient died or discharged to hospice

Secondary outcomes

  1. Hospital length of stay

    Time frame: Single encounter

    Mean hospital length of stay, where mortality will be censored as longest possible length of stay

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Collaborators

  • Duke University
  • Emory University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.