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

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

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.

Study Overview

• Status: Completed
• Conditions: Stenotrophomonas Infection
• Intervention / Treatment: Drug: Levofloxacin; Drug: trimethoprim-sulfamethoxazole

• Study Type: Observational
• Enrollment (Actual): 1621

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult inpatients with Stenotrophomonas maltophilia blood stream or lower respiratory tract infection

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death or hospice discharge	Patient died or discharged to hospice	In-hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Mean hospital length of stay, where mortality will be censored as longest possible length of stay	Single encounter

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborators: Emory University; Duke University
• Investigators: Principal Investigator: Sameer Kadri, MD, National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): April 27, 2021

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Stenotrophomonas maltophilia, Stenotrophomonas, Levofloxacin, TMP/SMX, Trimethoprim-sulfamethoxazole
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Dyskinesia Agents; Anti-Infective Agents, Urinary; Renal Agents; Cytochrome P-450 CYP2C8 Inhibitors; Levofloxacin; Ofloxacin; Trimethoprim; Sulfamethoxazole; Trimethoprim, Sulfamethoxazole Drug Combination
• Other Study ID Numbers: BD022382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: N/A, this data is deidentified

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No