Stenotrophomonas Maltophilia InfectionNCT06112938
Alternative Treatment Strategies for Stenotrophomonas Maltophilia Pneumonia
An observational study of Stenotrophomonas Maltophilia Infection, run by Methodist Health System at 1 site in United States.
Trial summary
Multi center, retrospective chart review of patients admitted to MHS hospitals from April 1, 2017 to March 31, 2022. Patients will be identified through the electronic medical record, and data from those that meet the study inclusion and exclusion criteria will be analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenotrophomonas Maltophilia Infection
- What is being tested?
- Antibiotic
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2022to 14 Jul 2025
- 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: This is a retrospective chart review study limited to only patients meeting inclusion and exclusion criteria. We plan to conduct the retrospective chart review of all patients identified during the study period that meet the inclusion and exclusion criteria.
Who may be able to join
- ≥18 years of age
- S. maltophilia isolated on respiratory or blood culture
Who cannot join
- Those that do not meet the inclusion criteria outlined in Section 4.1.
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75201
About this study
Multi center, retrospective chart review of patients admitted to MHS hospitals from April 1, 2017 to March 31, 2022. Patients will be identified through the electronic medical record, and data from those that meet the study inclusion and exclusion criteria will be analyzed. Minimum inhibitory concentration (MIC) data will be interpreted per Clinical \& Laboratory Standards Institute (CLSI) standards to determine local patterns of resistance. Multivariable logistic regression will be performed to determine predictors of mortality for S. maltophilia isolates.
Read the detailed description
Stenotrophomonas maltophilia is an aerobic, non-fermenting, Gram-negative bacillus recognized by the World Health Organization as one of the leading multi-drug resistant nosocomial pathogens worldwide. The Investigators aim to examine differences in clinical outcomes and failure rates between standard and alternative treatment strategies such as minocycline (or moxifloxacin, ciprofloxacin, ceftazidime) alone or in combination with TMP-SMX, alternative TMP-SMX dosing regimens, or variations in durations of therapy for the treatment of S. maltophilia infections within Methodist Health System (MHS).
- Conditions
- Stenotrophomonas Maltophilia Infection
- Being tested
- Antibiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
We aim to examine differences in clinical outcomes and failure rates between standard and alternative treatment strategies such as minocycline (or moxifloxacin, ciprofloxacin, ceftazidime) alone or in combination with TMP-SMX, alternative TMP-SMX dosing regimens, or variations in durations of therapy for the treatment of S. maltophilia infections within Methodist Health System (MHS).
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in clinical failure rates between standard and alternative therapy
defined as meeting any of the following criteria: 1) isolation of S. maltophilia from a subsequently collected culture from the same site of index culture after at least 48 hours of therapy; 2) alteration of monotherapy after at least 48 hours of treatment for either an adverse event or concern for clinical failure; or 3) 30-day in-hospital all-cause mortality.
Measured: 30 days
Secondary outcomes (1)
Clinical outcomes such as ICU LOS
related/attributable mortality, and rates of serious adverse events.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start21 Jul 2022
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenotrophomonas Maltophilia 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathew Crotty, PharmD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112938
- Sponsor's protocol ID
- 034.PHA.2022.A
- Status last verified
- Jul 2025
- First submitted
- 21 Oct 2022
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Treatment Strategies for Stenotrophomonas Maltophilia Pneumonia
- ClinicalTrials.gov ID
- NCT06112938
- Acronym / sponsor ID
- 034.PHA.2022.A
- Conditions
- Stenotrophomonas Maltophilia Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 2 Nov 2023 (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.
Multi center, retrospective chart review of patients admitted to MHS hospitals from April 1, 2017 to March 31, 2022. Patients will be identified through the electronic medical record, and data from those that meet the study inclusion and exclusion criteria will be analyzed. Minimum inhibitory concentration (MIC) data will be interpreted per Clinical \& Laboratory Standards Institute (CLSI) standards to determine local patterns of resistance. Multivariable logistic regression will be performed to determine predictors of mortality for S. maltophilia isolates.
Detailed description
Stenotrophomonas maltophilia is an aerobic, non-fermenting, Gram-negative bacillus recognized by the World Health Organization as one of the leading multi-drug resistant nosocomial pathogens worldwide. The Investigators aim to examine differences in clinical outcomes and failure rates between standard and alternative treatment strategies such as minocycline (or moxifloxacin, ciprofloxacin, ceftazidime) alone or in combination with TMP-SMX, alternative TMP-SMX dosing regimens, or variations in durations of therapy for the treatment of S. maltophilia infections within Methodist Health System (MHS).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective chart review study limited to only patients meeting inclusion and exclusion criteria. We plan to conduct the retrospective chart review of all patients identified during the study period that meet the inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- ≥18 years of age
- S. maltophilia isolated on respiratory or blood culture
Key exclusion criteria (1 listed)
- Those that do not meet the inclusion criteria outlined in Section 4.1.
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 |
|---|---|---|
| AntibioticWe aim to examine differences in clinical outcomes and failure rates between standard and alternative treatment strategies such as minocycline (or moxifloxacin, ciprofloxacin, ceftazidime) alone or in combination with TMP-SMX, alternative TMP-SMX dosing regimens, or variations in durations of therapy for the treatment of S. maltophilia infections within Methodist Health System (MHS). | Drug | – |
Primary outcome
the difference in clinical failure rates between standard and alternative therapy
Time frame: 30 days
defined as meeting any of the following criteria: 1) isolation of S. maltophilia from a subsequently collected culture from the same site of index culture after at least 48 hours of therapy; 2) alteration of monotherapy after at least 48 hours of treatment for either an adverse event or concern for clinical failure; or 3) 30-day in-hospital all-cause mortality.
1 secondary outcome
Clinical outcomes such as ICU LOS
Time frame: 30 days
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 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Stenotrophomonas Maltophilia 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.
Mathew Crotty, PharmD principal investigator
The Methodist Hospital Research Institute
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 Maltophilia Infection, run by Methodist Health System 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 2 inclusion and 1 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 Jul 2025. 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?
the difference in clinical failure rates between standard and alternative therapy (time frame: 30 days). 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 Jul 2025.