Pneumonia, Ventilator-AssociatedRETROSTENONCT03506191
Pneumonia Due to Stenotrophomonas Maltophilia in ICUs
An observational study of Pneumonia, Ventilator-Associated and Stenotrophomonas Infection, run by Groupe Hospitalier Pitie-Salpetriere at 4 sites in France.
Trial summary
Pneumonia is a major cause of ICU admission, or may complicate ICU course. Among the causative pathogens, Stenotrophomonas Maltophilia is a rare pathogen, but affects usually patients with chronic pulmonary co-morbidities, or with long duration of mechanical ventilation and multiples treatment with broad spectrum… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated, Stenotrophomonas Infection, Critical Illness
- How many people
- 300 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Jan 2017to 30 Sep 2018
- 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: Patients hospitalized in Intensive Care Unit and presenting pneumonia due to Stenotrophomonas maltophilia
Who may be able to join
- Patients older than 18 years
- Documented Stenotrophomonas maltophilia pneumonia:
- Clinical suspicion (≥ two criteria including: fever> 38.5°C, leukocytosis > 10^9/L or leukopenia < 4.10^8/L, purulent tracheobronchial secretions and a new or persistent infiltrate on chest radiography).
- Documented Stenotrophomonas maltophilia positive quantitative culture of a respiratory sample: bronchoalveolar lavage fluid (significant threshold, >10^4cfu/ml) or plugged telescopic catheter (significant threshold, >10^3cfu/ml) or quantitative endotracheal aspirate (significant threshold, >10^6cfu/ml).
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
France4 sites
Réanimation Polyvalente CHR Metz-Thionville
Metz
Department of Anesthesiology and Critical Care Medicine, University Hospital of NANCY
Nancy, 54500
Anesthesiology and Critical Care Medicine, Groupe Hospitalier Pitié-Salpêtrière
Paris, Île-de-France Region, 75013
Department of Anesthesiology and Critical Care Medicine, University Hospital of Strasbourg
Strasbourg
About this study
Official title: Pneumonia Due to Stenotrophomonas Maltophilia in Intensive Care Units: a Multicentre Retrospective Study
Pneumonia is a major cause of ICU admission, or may complicate ICU course. Among the causative pathogens, Stenotrophomonas Maltophilia is a rare pathogen, but affects usually patients with chronic pulmonary co-morbidities, or with long duration of mechanical ventilation and multiples treatment with broad spectrum antimicrobial therapy. However, there are only a paucity of data regarding epidemiology, impact and outcome of Pneumonia due to Stenotrophomonas Maltophilia in critically ill patients.
Primary objective was to study factors associated with mortality in case of Pneumonia due to Stenotrophomonas Maltophilia. Secondary objectives were to describe factors associated with morbidity of Pneumonia due to Stenotrophomonas Maltophilia (duration of mechanical ventilation, ICU length of stay), and to report the characteristics of critically ill patients presenting Pneumonia due to Stenotrophomonas Maltophilia.
- Conditions
- Pneumonia, Ventilator-Associated, Stenotrophomonas Infection, Critical Illness, Pneumonia, Bacterial
- Keywords
- Stenotrophomonas maltophilia, Pneumonia, Intensive Care Unit
- Medical subject headings
- Pneumonia, Ventilator-Associated, Critical Illness, Pneumonia, Bacterial, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Treatment failure is defined as composite of death and recurrence of pneumonia due to Stenotrophomonas Maltophilia within 30 days of the first episode
Measured: Day 30
Secondary outcomes (3)
Duration of mechanical ventilation
Number of days under mechanical ventilation
Measured: Day 30
Recurrence of pneumonia due to Stenotrophomonas Maltophilia
New onset of pneumonia due to Stenotrophomonas Maltophilia
Measured: Day 30
Mortality
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 Jan 2017
- Primary completion30 Jul 2018
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrien Bouglé, Groupe Hospitalier Pitie-Salpetriere
- Investigators
- Adrien Bouglé, MD, Study director, APHPPhilippe Guerci, MD, Principal investigator, CHRU NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506191
- Sponsor's protocol ID
- RETROSTENO
- Acronym
- RETROSTENO
- Status last verified
- Jul 2018
- First submitted
- 13 Apr 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guerci P, Bellut H, Mokhtari M, Gaudefroy J, Mongardon N, Charpentier C, Louis G, Tashk P, Dubost C, Ledochowski S, Kimmoun A, Godet T, Pottecher J, Lalot JM, Novy E, Hajage D, Bougle A; AZUREA research network. Outcomes of Stenotrophomonas maltophilia hospital-acquired pneumonia in intensive care unit: a nationwide retrospective study. Crit Care. 2019 Nov 21;23(1):371. doi: 10.1186/s13054-019-2649-5.
PubMed 31752976
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumonia Due to Stenotrophomonas Maltophilia in Intensive Care Units: a Multicentre Retrospective Study
- ClinicalTrials.gov ID
- NCT03506191
- Acronym / sponsor ID
- RETROSTENO / RETROSTENO
- Conditions
- Pneumonia, Ventilator-Associated, Stenotrophomonas Infection, Critical Illness, Pneumonia, Bacterial
- Keywords
- Stenotrophomonas maltophilia, Pneumonia, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 24 Apr 2018 (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.
Pneumonia is a major cause of ICU admission, or may complicate ICU course. Among the causative pathogens, Stenotrophomonas Maltophilia is a rare pathogen, but affects usually patients with chronic pulmonary co-morbidities, or with long duration of mechanical ventilation and multiples treatment with broad spectrum antimicrobial therapy. However, there are only a paucity of data regarding epidemiology, impact and outcome of Pneumonia due to Stenotrophomonas Maltophilia in critically ill patients.
Primary objective was to study factors associated with mortality in case of Pneumonia due to Stenotrophomonas Maltophilia. Secondary objectives were to describe factors associated with morbidity of Pneumonia due to Stenotrophomonas Maltophilia (duration of mechanical ventilation, ICU length of stay), and to report the characteristics of critically ill patients presenting Pneumonia due to Stenotrophomonas Maltophilia.
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
- Patients hospitalized in Intensive Care Unit and presenting pneumonia due to Stenotrophomonas maltophilia
Key inclusion criteria (4 listed)
- Patients older than 18 years
- Clinical suspicion (≥ two criteria including: fever> 38.5°C, leukocytosis > 10^9/L or leukopenia < 4.10^8/L, purulent tracheobronchial secretions and a new or persistent infiltrate on chest radiography).
- Documented Stenotrophomonas maltophilia positive quantitative culture of a respiratory sample: bronchoalveolar lavage fluid (significant threshold, >10^4cfu/ml) or plugged telescopic catheter (significant threshold, >10^3cfu/ml) or quantitative endotracheal aspirate (significant threshold, >10^6cfu/ml).
Key exclusion criteria (1 listed)
- None
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
Treatment failure
Time frame: Day 30
Treatment failure is defined as composite of death and recurrence of pneumonia due to Stenotrophomonas Maltophilia within 30 days of the first episode
3 secondary outcomes
Duration of mechanical ventilation
Time frame: Day 30
Recurrence of pneumonia due to Stenotrophomonas Maltophilia
Time frame: Day 30
Mortality
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Derived from this study: PubMed 31752976Guerci P, Bellut H, Mokhtari M, Gaudefroy J, Mongardon N, Charpentier C, Louis G, Tashk P, Dubost C, Ledochowski S, Kimmoun A, Godet T, Pottecher J, Lalot JM, Novy E, Hajage D, Bougle A; AZUREA research network. Outcomes of Stenotrophomonas maltophilia hospital-acquired pneumonia in intensive care unit: a nationwide retrospective study. Crit Care. 2019 Nov 21;23(1):371. doi: 10.1186/s13054-019-2649-5.
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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. This study is not recruiting at the moment.
Adrien Bouglé, MD study director
APHP
Philippe Guerci, MD principal investigator
CHRU NANCY
4 sites 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 Infection, run by Groupe Hospitalier Pitie-Salpetriere at 4 sites 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 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: status not confirmed, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
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?
Treatment failure (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506191, which also lists 1 linked publication.
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 1 Aug 2018.