Pneumonia, Ventilator-AssociatedNCT07052604
Antibiotic Treatment for Pneumonia Caused by Stenotrophomonas Maltophilia in ICU Patients
An observational study of Pneumonia, Ventilator-Associated and Stenotrophomonas Maltophilia, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
This study looks at how different antibiotic treatments affect patients in intensive care who have pneumonia caused by the bacteria Stenotrophomonas maltophilia. It compares using one antibiotic versus two antibiotics, and treatment lengths of 7 days versus 14 days, to see which approach helps patients survive better. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated, Stenotrophomonas Maltophilia, Intensive Care Units
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2023to 15 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: The study population consists of adult patients admitted to the Medical Intensive Care Unit (ICU) between January 2018 and December 2023 who are intubated and mechanically ventilated, and who develop ventilator-associated pneumonia caused by Stenotrophomonas maltophilia. These patients represent a critical care group at high risk for serious infections with multidrug-resistant bacteria.
Who may be able to join
- Adult patients (age ≥ 18 years)
- Hospitalized in Medical Intensive Care Unit between January 1, 2018, and December 31, 2023
- Intubated and mechanically ventilated
- Diagnosed with ventilator-associated pneumonia caused by Stenotrophomonas maltophilia
Who cannot join
- Patients under 18 years old
- Patients who refuse the use of their data for research purposes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Saint-Denis
Saint-Denis, France
Nolan HASSOLD, 0142356208, coordination.rechercheclinique@ghtpdfr.fr
About this study
This study looks at how different antibiotic treatments affect patients in intensive care who have pneumonia caused by the bacteria Stenotrophomonas maltophilia. It compares using one antibiotic versus two antibiotics, and treatment lengths of 7 days versus 14 days, to see which approach helps patients survive better. The study also examines how resistant the bacteria are to antibiotics and how often the pneumonia comes back.
- Conditions
- Pneumonia, Ventilator-Associated, Stenotrophomonas Maltophilia, Intensive Care Units, Anti-Bacterial Agents, Drug Resistance, Bacterial
- Medical subject headings
- Pneumonia, Ventilator-Associated
What is being measured
The primary outcome is the main question the study is designed to answer.
patient survival based on the antibiotic treatment strategy used (monotherapy vs. combination therapy and 7 vs. 14 days duration).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start15 Dec 2023
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052604
- Sponsor's protocol ID
- 0055_STENO
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment for Pneumonia Caused by Stenotrophomonas Maltophilia in ICU Patients
- ClinicalTrials.gov ID
- NCT07052604
- Acronym / sponsor ID
- 0055_STENO
- Conditions
- Pneumonia, Ventilator-Associated, Stenotrophomonas Maltophilia, Intensive Care Units, Anti-Bacterial Agents, Drug Resistance, Bacterial
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 4 Jul 2025 (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 looks at how different antibiotic treatments affect patients in intensive care who have pneumonia caused by the bacteria Stenotrophomonas maltophilia. It compares using one antibiotic versus two antibiotics, and treatment lengths of 7 days versus 14 days, to see which approach helps patients survive better. The study also examines how resistant the bacteria are to antibiotics and how often the pneumonia comes back.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients admitted to the Medical Intensive Care Unit (ICU) between January 2018 and December 2023 who are intubated and mechanically ventilated, and who develop ventilator-associated pneumonia caused by Stenotrophomonas maltophilia. These patients represent a critical care group at high risk for serious infections with multidrug-resistant bacteria.
Key inclusion criteria (4 listed)
- Adult patients (age ≥ 18 years)
- Hospitalized in Medical Intensive Care Unit between January 1, 2018, and December 31, 2023
- Intubated and mechanically ventilated
- Diagnosed with ventilator-associated pneumonia caused by Stenotrophomonas maltophilia
Key exclusion criteria (2 listed)
- Patients under 18 years old
- Patients who refuse the use of their data for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
patient survival based on the antibiotic treatment strategy used (monotherapy vs. combination therapy and 7 vs. 14 days duration).
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
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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.
Centre Hospitalier de Saint-Denis
Saint-Denis, France
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 Pneumonia, Ventilator-Associated and Stenotrophomonas Maltophilia, run by Centre Hospitalier de Saint-Denis at 1 site in France.
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 2 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: looking for participants now, as of the sponsor's last update on 4 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient survival based on the antibiotic treatment strategy used (monotherapy vs. combination therapy and 7 vs. 14 days duration). (time frame: 28 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 4 Jul 2025.