Ventilator-associated PneumoniaPROVIDENCENCT05450796
Prognosis and Virulence Determination of Capsule and Endotoxin During Klebsiella Spp. Ventilator-associated Pneumonias
An observational study of Ventilator-associated Pneumonia, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Ventilator-associated pneumonia is the leading cause of nosocomial infection in the ICU. The pathogens responsible are multiple, but enterobacteria constitute a major source of pathogens involved. Within this family, Klebsiella spp. and Escherichia coli are the two most frequent genera, with Klebsiella spp. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Pneumonia
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2022to 31 Dec 2024
- 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
- Adult, Older adult
Study population: - Patient hospitalized in an intensive care unit, with ventilator-associated Klebsiella spp. pneumonia between between July 1, 2022 and July 1, 2024
Who may be able to join
- Patient whose age is ≥ 18 years
- Patient hospitalized in an intensive care unit
- Patient with ventilator-associated Klebsiella spp. pneumonia
- French-speaking patient
Who cannot join
- Patient with a severe psychiatric disorder
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient who objects to the use of his or her data for this research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
Helene BEAUSSIER, PharmD, PhD
About this study
Ventilator-associated pneumonia is the leading cause of nosocomial infection in the ICU. The pathogens responsible are multiple, but enterobacteria constitute a major source of pathogens involved. Within this family, Klebsiella spp. and Escherichia coli are the two most frequent genera, with Klebsiella spp. often present in severe forms. The factors associated with the occurrence of Ventilator-associated pneumonia and its adverse course depend on host defenses and the virulence of the pathogen. The virulence of Klebsiella spp. depends on several structures, notably the presence of a capsule, the particularities of its lipopolysaccharide, its adhesins (type 3 fimbriae), its capacity to capture iron (siderophores). The objective of this work is to evaluate the role of these different virulence mechanisms in the evolution of Ventilator-associated pneumonia and the hospital prognosis.
- Conditions
- Ventilator-associated Pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of 2-hydroxymyristate within lipid A of lipopolysaccharide in the prognosis of mechanically ventilated pneumonia caused by Klebsiella spp.
This outcome corresponds to the prognostic value (prediction of clinical cure) of the studied virulence parameters (myristate hydroxylation, presence of fimbriae, expression of siderophores, expression of capsule) at D7 of effective antibiotic treatment, according to the virulence parameters of the pathogen, after adjustment on known prognostic factors.
This value will be estimated by the adjusted HR, the improvement of the model fit, the number of patients who change classification (cured/not cured) after inclusion of this factor.
Measured: Month 1
Secondary outcomes (1)
Effect of other virulence factors on the evolution of ventilator-associated pneumonia
This outcome corresponds to the prognostic value (accuracy of recurrence of pulmonary infection under mechanical ventilation with the same germ (Klebsiella spp.) during the stay in intensive care.
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start17 Jun 2022
- Primary completion15 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ventilator-associated PneumoniaStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François BEAUSSIER, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450796
- Sponsor's protocol ID
- PROVIDENCE
- Acronym
- PROVIDENCE
- Status last verified
- Aug 2022
- First submitted
- 5 Jul 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bouadma L, Sonneville R, Garrouste-Orgeas M, Darmon M, Souweine B, Voiriot G, Kallel H, Schwebel C, Goldgran-Toledano D, Dumenil AS, Argaud L, Ruckly S, Jamali S, Planquette B, Adrie C, Lucet JC, Azoulay E, Timsit JF; OUTCOMEREA Study Group. Ventilator-Associated Events: Prevalence, Outcome, and Relationship With Ventilator-Associated Pneumonia. Crit Care Med. 2015 Sep;43(9):1798-806. doi: 10.1097/CCM.0000000000001091.
PubMed 25978340Wang Y, Eldridge N, Metersky ML, Verzier NR, Meehan TP, Pandolfi MM, Foody JM, Ho SY, Galusha D, Kliman RE, Sonnenfeld N, Krumholz HM, Battles J. National trends in patient safety for four common conditions, 2005-2011. N Engl J Med. 2014 Jan 23;370(4):341-51. doi: 10.1056/NEJMsa1300991.
PubMed 24450892Damas P, Layios N, Seidel L, Nys M, Melin P, Ledoux D. Severity of ICU-acquired pneumonia according to infectious microorganisms. Intensive Care Med. 2011 Jul;37(7):1128-35. doi: 10.1007/s00134-011-2255-8. Epub 2011 May 26.
PubMed 21614638Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.
PubMed 19952319Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.
PubMed 11934711Berra L, Panigada M, De Marchi L, Greco G, Z -Xi Y, Baccarelli A, Pohlmann J, Costello KF, Appleton J, Mahar R, Lewandowski R, Ravitz L, Kolobow T. New approaches for the prevention of airway infection in ventilated patients. Lessons learned from laboratory animal studies at the National Institutes of Health. Minerva Anestesiol. 2003 May;69(5):342-7.
PubMed 12768164Crnich CJ, Safdar N, Maki DG. The role of the intensive care unit environment in the pathogenesis and prevention of ventilator-associated pneumonia. Respir Care. 2005 Jun;50(6):813-36; discussion 836-8.
PubMed 15913471
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis and Virulence Determination of Capsule and Endotoxin During Klebsiella Spp. Ventilator-associated Pneumonias
- ClinicalTrials.gov ID
- NCT05450796
- Acronym / sponsor ID
- PROVIDENCE / PROVIDENCE
- Conditions
- Ventilator-associated Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jul 2022 (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.
Ventilator-associated pneumonia is the leading cause of nosocomial infection in the ICU. The pathogens responsible are multiple, but enterobacteria constitute a major source of pathogens involved. Within this family, Klebsiella spp. and Escherichia coli are the two most frequent genera, with Klebsiella spp. often present in severe forms. The factors associated with the occurrence of Ventilator-associated pneumonia and its adverse course depend on host defenses and the virulence of the pathogen. The virulence of Klebsiella spp. depends on several structures, notably the presence of a capsule, the particularities of its lipopolysaccharide, its adhesins (type 3 fimbriae), its capacity to capture iron (siderophores). The objective of this work is to evaluate the role of these different virulence mechanisms in the evolution of Ventilator-associated pneumonia and the hospital prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- - Patient hospitalized in an intensive care unit, with ventilator-associated Klebsiella spp. pneumonia between between July 1, 2022 and July 1, 2024
Key inclusion criteria (4 listed)
- Patient whose age is ≥ 18 years
- Patient hospitalized in an intensive care unit
- Patient with ventilator-associated Klebsiella spp. pneumonia
- French-speaking patient
Key exclusion criteria (5 listed)
- Patient with a severe psychiatric disorder
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient who objects to the use of his or her data for this research
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
Role of 2-hydroxymyristate within lipid A of lipopolysaccharide in the prognosis of mechanically ventilated pneumonia caused by Klebsiella spp.
Time frame: Month 1
This outcome corresponds to the prognostic value (prediction of clinical cure) of the studied virulence parameters (myristate hydroxylation, presence of fimbriae, expression of siderophores, expression of capsule) at D7 of effective antibiotic treatment, according to the virulence parameters of the pathogen, after adjustment on known prognostic factors. This value will be estimated by the adjusted HR, the improvement of the model fit, the number of patients who change classification (cured/not cured) after inclusion of this factor.
1 secondary outcome
Effect of other virulence factors on the evolution of ventilator-associated pneumonia
Time frame: Month 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Background: PubMed 25978340Bouadma L, Sonneville R, Garrouste-Orgeas M, Darmon M, Souweine B, Voiriot G, Kallel H, Schwebel C, Goldgran-Toledano D, Dumenil AS, Argaud L, Ruckly S, Jamali S, Planquette B, Adrie C, Lucet JC, Azoulay E, Timsit JF; OUTCOMEREA Study Group. Ventilator-Associated Events: Prevalence, Outcome, and Relationship With Ventilator-Associated Pneumonia. Crit Care Med. 2015 Sep;43(9):1798-806. doi: 10.1097/CCM.0000000000001091.
- Background: PubMed 24450892Wang Y, Eldridge N, Metersky ML, Verzier NR, Meehan TP, Pandolfi MM, Foody JM, Ho SY, Galusha D, Kliman RE, Sonnenfeld N, Krumholz HM, Battles J. National trends in patient safety for four common conditions, 2005-2011. N Engl J Med. 2014 Jan 23;370(4):341-51. doi: 10.1056/NEJMsa1300991.
- Background: PubMed 21614638Damas P, Layios N, Seidel L, Nys M, Melin P, Ledoux D. Severity of ICU-acquired pneumonia according to infectious microorganisms. Intensive Care Med. 2011 Jul;37(7):1128-35. doi: 10.1007/s00134-011-2255-8. Epub 2011 May 26.
- Background: PubMed 19952319Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.
- Background: PubMed 11934711Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.
- Background: PubMed 12768164Berra L, Panigada M, De Marchi L, Greco G, Z -Xi Y, Baccarelli A, Pohlmann J, Costello KF, Appleton J, Mahar R, Lewandowski R, Ravitz L, Kolobow T. New approaches for the prevention of airway infection in ventilated patients. Lessons learned from laboratory animal studies at the National Institutes of Health. Minerva Anestesiol. 2003 May;69(5):342-7.
- Background: PubMed 15913471Crnich CJ, Safdar N, Maki DG. The role of the intensive care unit environment in the pathogenesis and prevention of ventilator-associated pneumonia. Respir Care. 2005 Jun;50(6):813-36; discussion 836-8.
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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.
François BEAUSSIER, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Ventilator-associated Pneumonia, run by Fondation Hôpital Saint-Joseph 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 5 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 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François PHILIPPART, MD (144127021 ext. +33, fphilippart@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of 2-hydroxymyristate within lipid A of lipopolysaccharide in the prognosis of mechanically ventilated pneumonia caused by Klebsiella spp. (time frame: Month 1). 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 NCT05450796, which also lists 7 linked publications.
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 Nov 2022.