Stenotrophomonas InfectionNCT04639817
Trimethoprim-Sulfamethoxazole vs Levofloxacin as Targeted Therapy for Stenotrophomonas Maltophilia Infections: a Retrospective Cohort Study
An observational study of Stenotrophomonas Infection, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenotrophomonas Infection
- What is being tested?
- Levofloxacin and trimethoprim-sulfamethoxazole
- How many people
- 1,621 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2020to 27 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult inpatients with Stenotrophomonas maltophilia blood stream or lower respiratory tract infection
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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.
- Conditions
- Stenotrophomonas Infection
- Being tested
- Levofloxacin, trimethoprim-sulfamethoxazole
- Keywords
- Stenotrophomonas maltophilia, Stenotrophomonas, Levofloxacin, TMP/SMX, Trimethoprim-sulfamethoxazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Levofloxacin administration
trimethoprim-sulfamethoxazoleDrug
Also called TMP/SMX
Trimethoprim-sulfamethoxazole administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: trimethoprim-sulfamethoxazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or hospice discharge
Patient died or discharged to hospice
Measured: In-hospital
Secondary outcomes (1)
Hospital length of stay
Mean hospital length of stay, where mortality will be censored as longest possible length of stay
Measured: Single encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start14 Aug 2020
- Primary completion31 Jan 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenotrophomonas InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,621 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Duke University, Emory University
- Responsible party
- Principal investigator, Sameer Kadri, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Sameer Kadri, MD, Principal investigator, National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639817
- Sponsor's protocol ID
- BD022382
- Status last verified
- Apr 2021
- First submitted
- 19 Nov 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: N/A, this data is deidentified
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimethoprim-Sulfamethoxazole or Levofloxacin? A Retrospective Cohort Study of Targeted Therapy for Stenotrophomonas Maltophilia Blood Stream and Lower Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT04639817
- Acronym / sponsor ID
- BD022382
- Conditions
- Stenotrophomonas Infection
- Keywords
- Stenotrophomonas maltophilia, Stenotrophomonas, Levofloxacin, TMP/SMX, Trimethoprim-sulfamethoxazole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,621 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- Duke University, Emory University
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin targeted therapy | – | Drug: LevofloxacinPatients 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 | – | Drug: trimethoprim-sulfamethoxazolePatients with Stenotrophomonas maltophilia bacteremia or lower respiratory tract infection who received TMP/SMX from day of culture positivity (day 0) through day +7. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult inpatients with Stenotrophomonas maltophilia blood stream or lower respiratory tract infection
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevofloxacinLevofloxacin administration | Drug | Levofloxacin targeted therapy |
| trimethoprim-sulfamethoxazoleAlso: TMP/SMXTrimethoprim-sulfamethoxazole administration | Drug | TMP/SMX targeted therapy |
Primary outcome
Death or hospice discharge
Time frame: In-hospital
Patient died or discharged to hospice
1 secondary outcome
Hospital length of stay
Time frame: Single encounter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No. N/A, this data is deidentified
Related trials for Stenotrophomonas Infection
Not yet recruitingPhase 1
Safety of Combined Intravenous Antibiotic and Bacteriophage Therapy in Adults With Cystic Fibrosis and Antibiotic-Resistant Lung Infections
CF - Cystic Fibrosis, Klebsiella Pneumoniae Infection
RecruitingObservational study
Antibiotic Treatment for Pneumonia Caused by Stenotrophomonas Maltophilia in ICU Patients
Pneumonia, Ventilator-Associated, Stenotrophomonas Maltophilia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameer Kadri, MD principal investigator
National Institutes of Health (NIH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stenotrophomonas Infection, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or hospice discharge (time frame: In-hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.