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

NCT04639817 | Completed FDA Drug

• 1 other identifier: BD022382
• Study Type: observational
• Target: 1,621
• Locations: 1 country
• Sites: 1

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.

Conditions

Stenotrophomonas Infection

Keywords

Stenotrophomonas maltophilia, Stenotrophomonas, Levofloxacin, TMP/SMX, Trimethoprim-sulfamethoxazole

Outcome Measures

Primary Outcomes (1)

• Death or hospice discharge

  Patient died or discharged to hospice

  In-hospital

Secondary Outcomes (1)

• Hospital length of stay

  Single encounter

Study Arms (2)

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

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

Interventions

Levofloxacin DRUG

Levofloxacin administration

Levofloxacin targeted therapy

trimethoprim-sulfamethoxazole DRUG

Trimethoprim-sulfamethoxazole administration

Also known as: TMP/SMX

TMP/SMX targeted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• Duke University: collaborator
• Emory University: collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Interventions

Levofloxacin; Trimethoprim, Sulfamethoxazole Drug Combination

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Sameer Kadri, MD

  National Institutes of Health (NIH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Clinician, Critical Care Medicine Department

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 23, 2020
• Study Start: August 14, 2020
• Primary Completion: January 31, 2021
• Study Completion: April 27, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)