Ventilator Associated PneumoniaNCT04840940
Presepsin Biomarker for Ventilator-associated Pneumonia Diagnosis in COVID-19 Patients
An observational study of Ventilator Associated Pneumonia and Covid19, run by San Luigi Gonzaga Hospital at 1 site in Italy.
Trial summary
This study is observational and double blind. It evaluates the validity of presepsin (a serum biomarker of bacterial infections) as early biomarker of Ventilator Associated Pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Covid19
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 21 Dec 2020to 21 Dec 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: Patients requiring invasive mechanical ventilation for Sars-Cov 2 interstitial pneumonia
Who may be able to join
- ICU patients with Sars Cov 2 interstitial pneumonia requiring invasive mechanical ventilation
Who cannot join
- Age less than 18 years
- Pregnancy
- Chronic renal failure stage III or more
- End stage liver disease
- Patients already present in the ICU at the beginning of the study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
SCDU Anestesia e Rianimazione, AOU San Luigi Gonzaga
Orbassano, Turin, 10043
Pietro Caironi, 00390119026510, pietro.caironi@unito.it
About this study
Official title: Presepsin as an Early Biomarker for Ventilator-associated Pneumonia (VAP) Diagnosis in COVID-19 Patients: a Prospective Double Blind Observational Study
This study is observational and double blind. It evaluates the validity of presepsin (a serum biomarker of bacterial infections) as early biomarker of Ventilator Associated Pneumonia. It will be measured at day 0 (ICU admission) and every 48 hours in every patient with Sars-Cov 2 interstitial pneumonia requiring invasive mechanical ventilation (see inclusion ad exclusion criteria) until Day 30, ICU discharge or ICU death. There will be no change in clinical practice and in pneumonia diagnosis. We will examine how the elevation of presepsin level could be an early marker of ventilator associated pneumonia or a marker of bacterial pneumonia at ICU admission, before the microbiological results or clinical diagnosis.
Read the detailed description
This study will be a single center, double blind observational study.
Measurements of presepsin blood level will be performed in all patients with interstitial Sars-Cov-2 pneumonia admitted to ICU, at the time of the start of invasive mechanical ventilation and every 48 hours for the first 30 days of ICU stay. Surveillance respiratory samples (endotracheal aspiration) will be performed according to clinical practice (at ICU admission and every Mondays and Thursdays in all patients undergoing invasive mechanical ventilation).
In all patients admitted to ICU with invasive mechanically ventilation, a bronchoalveolar lavage with rapid microbiological method (film array for the research of the main respiratory pathogens) will be performed, according to common clinical practice.
VAP diagnosis will be made based upon the evidence of new lung infiltrates (chest radiography or chest computed tomography) in association with the presence of a pathogen isolated in the non-invasive respiratory sample with semi-quantitative method, according to IDSA and American Thoracic Society guidelines, as well as the presence of other sign of infection (fever, leukocytosis, worsening of oxygenation).
The attending physician in charge of the patient enrolled, clinically making the diagnosis of VAP will be blinded of presepsin levels. As a consequence, during the study period, no variation of the clinical practice applied will be performed, and no influence on the care provided to patients included will be determined by the measurement of plasma presepsin.
In the current study, we aim to answer to the following questions:
- Does a high level of plasma presepsin in patients with a Sars Cov 2 interstitial pneumonia at the time of ICU admission predict the presence of a bacterial respiratory co-infection?
- Do presepsin levels early predict the occurrence of VAP in patients with COVID-19 disease?
- Does such variation become evident at the time of VAC, therefore anticipating the diagnosis of IVAC? The latter issue might be particularly important in order to commence antibiotic therapy earlier than the diagnosis of IVAC.
- Conditions
- Ventilator Associated Pneumonia, Covid19
- Keywords
- Presepsin, VAP, Mechanical ventilation, COVID-19, Ventilator associated pneumonia, Sars-Cov-2
- Medical subject headings
- Pneumonia, Ventilator-Associated, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate daily variations of presepsin levels as an early marker of VAP in COVID 19 patients
Circulating presepsin levels every other day (from day 0 to day 30)
Measured: Time from ICU admission to day 30 or to ICU discharge or to ICU death
Secondary outcomes (3)
To evaluate whether presepsin level can predict the presence of a bacterial respiratory co-infection at the time of ICU admission in patient with Sars-CoV-2 interstitial pneumonia
Circulating presepsin levels every other day (from day 0 to day 2)
Measured: Time from ICU admission to day 2
To evaluate the role of circulating presepsin time course during the treatment of VAP as a clinical marker of the adequacy of the antibiotic therapy applied
Circulating presepsin levels every other day (from day 0 to day 30)
Measured: Time from ICU admission to day 30 or to ICU discharge or to ICU death
To evaluate whether plasma levels of presepsin may distinguish the presence of VAP versus VAT (ventilator-associated tracheobronchitis).
Circulating presepsin levels every other day (from day 0 to day 30)
Measured: Time from ICU admission to day 30 or to ICU discharge or to ICU death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start21 Dec 2020
- Primary completion21 Dec 2021 (estimated)
- Study completion21 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Luigi Gonzaga Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Caironi, San Luigi Gonzaga Hospital
- Investigators
- Pietro Caironi, Principal investigator, San Luigi Gonzaga HospitalGuido Bussone, Principal investigator, San Luigi Gonzaga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840940
- Sponsor's protocol ID
- MACOSX
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14.
PubMed 27418577Melsen WG, Rovers MM, Groenwold RH, Bergmans DC, Camus C, Bauer TT, Hanisch EW, Klarin B, Koeman M, Krueger WA, Lacherade JC, Lorente L, Memish ZA, Morrow LE, Nardi G, van Nieuwenhoven CA, O'Keefe GE, Nakos G, Scannapieco FA, Seguin P, Staudinger T, Topeli A, Ferrer M, Bonten MJ. Attributable mortality of ventilator-associated pneumonia: a meta-analysis of individual patient data from randomised prevention studies. Lancet Infect Dis. 2013 Aug;13(8):665-71. doi: 10.1016/S1473-3099(13)70081-1. Epub 2013 Apr 25.
PubMed 23622939Magill SS, Klompas M, Balk R, Burns SM, Deutschman CS, Diekema D, Fridkin S, Greene L, Guh A, Gutterman D, Hammer B, Henderson D, Hess D, Hill NS, Horan T, Kollef M, Levy M, Septimus E, VanAntwerpen C, Wright D, Lipsett P. Developing a new, national approach to surveillance for ventilator-associated events*. Crit Care Med. 2013 Nov;41(11):2467-75. doi: 10.1097/CCM.0b013e3182a262db.
PubMed 24162674Erb CT, Patel B, Orr JE, Bice T, Richards JB, Metersky ML, Wilson KC, Thomson CC. Management of Adults with Hospital-acquired and Ventilator-associated Pneumonia. Ann Am Thorac Soc. 2016 Dec;13(12):2258-2260. doi: 10.1513/AnnalsATS.201608-641CME. No abstract available.
PubMed 27925784Berton DC, Kalil AC, Teixeira PJ. Quantitative versus qualitative cultures of respiratory secretions for clinical outcomes in patients with ventilator-associated pneumonia. Cochrane Database Syst Rev. 2012 Jan 18;1:CD006482. doi: 10.1002/14651858.CD006482.pub3.
PubMed 22258968Fagon JY. Biological markers and diagnosis of ventilator-associated pneumonia. Crit Care. 2011;15(2):130. doi: 10.1186/cc10050. Epub 2011 Mar 9.
PubMed 21418551Luyt CE, Combes A, Reynaud C, Hekimian G, Nieszkowska A, Tonnellier M, Aubry A, Trouillet JL, Bernard M, Chastre J. Usefulness of procalcitonin for the diagnosis of ventilator-associated pneumonia. Intensive Care Med. 2008 Aug;34(8):1434-40. doi: 10.1007/s00134-008-1112-x. Epub 2008 Apr 18.
PubMed 18421435Luyt CE, Guerin V, Combes A, Trouillet JL, Ayed SB, Bernard M, Gibert C, Chastre J. Procalcitonin kinetics as a prognostic marker of ventilator-associated pneumonia. Am J Respir Crit Care Med. 2005 Jan 1;171(1):48-53. doi: 10.1164/rccm.200406-746OC. Epub 2004 Sep 24.
PubMed 15447947COVID-ICU Group on behalf of the REVA Network and the COVID-ICU Investigators. Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study. Intensive Care Med. 2021 Jan;47(1):60-73. doi: 10.1007/s00134-020-06294-x. Epub 2020 Oct 29.
PubMed 33211135Mussap M, Noto A, Fravega M, Fanos V. Soluble CD14 subtype presepsin (sCD14-ST) and lipopolysaccharide binding protein (LBP) in neonatal sepsis: new clinical and analytical perspectives for two old biomarkers. J Matern Fetal Neonatal Med. 2011 Oct;24 Suppl 2:12-4. doi: 10.3109/14767058.2011.601923.
PubMed 21740312Okamura Y, Yokoi H. Development of a point-of-care assay system for measurement of presepsin (sCD14-ST). Clin Chim Acta. 2011 Nov 20;412(23-24):2157-61. doi: 10.1016/j.cca.2011.07.024. Epub 2011 Aug 3.
PubMed 21839732Wu CC, Lan HM, Han ST, Chaou CH, Yeh CF, Liu SH, Li CH, Blaney GN 3rd, Liu ZY, Chen KF. Comparison of diagnostic accuracy in sepsis between presepsin, procalcitonin, and C-reactive protein: a systematic review and meta-analysis. Ann Intensive Care. 2017 Sep 6;7(1):91. doi: 10.1186/s13613-017-0316-z.
PubMed 28875483Masson S, Caironi P, Fanizza C, Thomae R, Bernasconi R, Noto A, Oggioni R, Pasetti GS, Romero M, Tognoni G, Latini R, Gattinoni L. Circulating presepsin (soluble CD14 subtype) as a marker of host response in patients with severe sepsis or septic shock: data from the multicenter, randomized ALBIOS trial. Intensive Care Med. 2015 Jan;41(1):12-20. doi: 10.1007/s00134-014-3514-2. Epub 2014 Oct 16.
PubMed 25319385Masson S, Caironi P, Spanuth E, Thomae R, Panigada M, Sangiorgi G, Fumagalli R, Mauri T, Isgro S, Fanizza C, Romero M, Tognoni G, Latini R, Gattinoni L; ALBIOS Study Investigators. Presepsin (soluble CD14 subtype) and procalcitonin levels for mortality prediction in sepsis: data from the Albumin Italian Outcome Sepsis trial. Crit Care. 2014 Jan 7;18(1):R6. doi: 10.1186/cc13183.
PubMed 24393424Klouche K, Cristol JP, Devin J, Gilles V, Kuster N, Larcher R, Amigues L, Corne P, Jonquet O, Dupuy AM. Diagnostic and prognostic value of soluble CD14 subtype (Presepsin) for sepsis and community-acquired pneumonia in ICU patients. Ann Intensive Care. 2016 Dec;6(1):59. doi: 10.1186/s13613-016-0160-6. Epub 2016 Jul 7.
PubMed 27389015
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presepsin as an Early Biomarker for Ventilator-associated Pneumonia (VAP) Diagnosis in COVID-19 Patients: a Prospective Double Blind Observational Study
- ClinicalTrials.gov ID
- NCT04840940
- Acronym / sponsor ID
- MACOSX
- Conditions
- Ventilator Associated Pneumonia, Covid19
- Keywords
- Presepsin, VAP, Mechanical ventilation, COVID-19, Ventilator associated pneumonia, Sars-Cov-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- San Luigi Gonzaga HospitalUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 21 Dec 2021 (estimated)
- Study completion
- 21 Dec 2021 (estimated)
- First posted
- 12 Apr 2021 (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 is observational and double blind. It evaluates the validity of presepsin (a serum biomarker of bacterial infections) as early biomarker of Ventilator Associated Pneumonia. It will be measured at day 0 (ICU admission) and every 48 hours in every patient with Sars-Cov 2 interstitial pneumonia requiring invasive mechanical ventilation (see inclusion ad exclusion criteria) until Day 30, ICU discharge or ICU death. There will be no change in clinical practice and in pneumonia diagnosis. We will examine how the elevation of presepsin level could be an early marker of ventilator associated pneumonia or a marker of bacterial pneumonia at ICU admission, before the microbiological results or clinical diagnosis.
Detailed description
This study will be a single center, double blind observational study.
Measurements of presepsin blood level will be performed in all patients with interstitial Sars-Cov-2 pneumonia admitted to ICU, at the time of the start of invasive mechanical ventilation and every 48 hours for the first 30 days of ICU stay. Surveillance respiratory samples (endotracheal aspiration) will be performed according to clinical practice (at ICU admission and every Mondays and Thursdays in all patients undergoing invasive mechanical ventilation).
In all patients admitted to ICU with invasive mechanically ventilation, a bronchoalveolar lavage with rapid microbiological method (film array for the research of the main respiratory pathogens) will be performed, according to common clinical practice.
VAP diagnosis will be made based upon the evidence of new lung infiltrates (chest radiography or chest computed tomography) in association with the presence of a pathogen isolated in the non-invasive respiratory sample with semi-quantitative method, according to IDSA and American Thoracic Society guidelines, as well as the presence of other sign of infection (fever, leukocytosis, worsening of oxygenation).
The attending physician in charge of the patient enrolled, clinically making the diagnosis of VAP will be blinded of presepsin levels. As a consequence, during the study period, no variation of the clinical practice applied will be performed, and no influence on the care provided to patients included will be determined by the measurement of plasma presepsin.
In the current study, we aim to answer to the following questions:
- Does a high level of plasma presepsin in patients with a Sars Cov 2 interstitial pneumonia at the time of ICU admission predict the presence of a bacterial respiratory co-infection?
- Do presepsin levels early predict the occurrence of VAP in patients with COVID-19 disease?
- Does such variation become evident at the time of VAC, therefore anticipating the diagnosis of IVAC? The latter issue might be particularly important in order to commence antibiotic therapy earlier than the diagnosis of IVAC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring invasive mechanical ventilation for Sars-Cov 2 interstitial pneumonia
Key inclusion criteria (1 listed)
- ICU patients with Sars Cov 2 interstitial pneumonia requiring invasive mechanical ventilation
Key exclusion criteria (5 listed)
- Age less than 18 years
- Pregnancy
- Chronic renal failure stage III or more
- End stage liver disease
- Patients already present in the ICU at the beginning of the study
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
To evaluate daily variations of presepsin levels as an early marker of VAP in COVID 19 patients
Time frame: Time from ICU admission to day 30 or to ICU discharge or to ICU death
Circulating presepsin levels every other day (from day 0 to day 30)
3 secondary outcomes
To evaluate whether presepsin level can predict the presence of a bacterial respiratory co-infection at the time of ICU admission in patient with Sars-CoV-2 interstitial pneumonia
Time frame: Time from ICU admission to day 2
To evaluate the role of circulating presepsin time course during the treatment of VAP as a clinical marker of the adequacy of the antibiotic therapy applied
Time frame: Time from ICU admission to day 30 or to ICU discharge or to ICU death
To evaluate whether plasma levels of presepsin may distinguish the presence of VAP versus VAT (ventilator-associated tracheobronchitis).
Time frame: Time from ICU admission to day 30 or to ICU discharge or to ICU death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Results publication: PubMed 27418577Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14.
- Results publication: PubMed 23622939Melsen WG, Rovers MM, Groenwold RH, Bergmans DC, Camus C, Bauer TT, Hanisch EW, Klarin B, Koeman M, Krueger WA, Lacherade JC, Lorente L, Memish ZA, Morrow LE, Nardi G, van Nieuwenhoven CA, O'Keefe GE, Nakos G, Scannapieco FA, Seguin P, Staudinger T, Topeli A, Ferrer M, Bonten MJ. Attributable mortality of ventilator-associated pneumonia: a meta-analysis of individual patient data from randomised prevention studies. Lancet Infect Dis. 2013 Aug;13(8):665-71. doi: 10.1016/S1473-3099(13)70081-1. Epub 2013 Apr 25.
- Results publication: PubMed 24162674Magill SS, Klompas M, Balk R, Burns SM, Deutschman CS, Diekema D, Fridkin S, Greene L, Guh A, Gutterman D, Hammer B, Henderson D, Hess D, Hill NS, Horan T, Kollef M, Levy M, Septimus E, VanAntwerpen C, Wright D, Lipsett P. Developing a new, national approach to surveillance for ventilator-associated events*. Crit Care Med. 2013 Nov;41(11):2467-75. doi: 10.1097/CCM.0b013e3182a262db.
- Results publication: PubMed 27925784Erb CT, Patel B, Orr JE, Bice T, Richards JB, Metersky ML, Wilson KC, Thomson CC. Management of Adults with Hospital-acquired and Ventilator-associated Pneumonia. Ann Am Thorac Soc. 2016 Dec;13(12):2258-2260. doi: 10.1513/AnnalsATS.201608-641CME. No abstract available.
- Results publication: PubMed 22258968Berton DC, Kalil AC, Teixeira PJ. Quantitative versus qualitative cultures of respiratory secretions for clinical outcomes in patients with ventilator-associated pneumonia. Cochrane Database Syst Rev. 2012 Jan 18;1:CD006482. doi: 10.1002/14651858.CD006482.pub3.
- Results publication: PubMed 21418551Fagon JY. Biological markers and diagnosis of ventilator-associated pneumonia. Crit Care. 2011;15(2):130. doi: 10.1186/cc10050. Epub 2011 Mar 9.
- Results publication: PubMed 18421435Luyt CE, Combes A, Reynaud C, Hekimian G, Nieszkowska A, Tonnellier M, Aubry A, Trouillet JL, Bernard M, Chastre J. Usefulness of procalcitonin for the diagnosis of ventilator-associated pneumonia. Intensive Care Med. 2008 Aug;34(8):1434-40. doi: 10.1007/s00134-008-1112-x. Epub 2008 Apr 18.
- Results publication: PubMed 15447947Luyt CE, Guerin V, Combes A, Trouillet JL, Ayed SB, Bernard M, Gibert C, Chastre J. Procalcitonin kinetics as a prognostic marker of ventilator-associated pneumonia. Am J Respir Crit Care Med. 2005 Jan 1;171(1):48-53. doi: 10.1164/rccm.200406-746OC. Epub 2004 Sep 24.
- Results publication: PubMed 33211135COVID-ICU Group on behalf of the REVA Network and the COVID-ICU Investigators. Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study. Intensive Care Med. 2021 Jan;47(1):60-73. doi: 10.1007/s00134-020-06294-x. Epub 2020 Oct 29.
- Results publication: PubMed 21740312Mussap M, Noto A, Fravega M, Fanos V. Soluble CD14 subtype presepsin (sCD14-ST) and lipopolysaccharide binding protein (LBP) in neonatal sepsis: new clinical and analytical perspectives for two old biomarkers. J Matern Fetal Neonatal Med. 2011 Oct;24 Suppl 2:12-4. doi: 10.3109/14767058.2011.601923.
- Results publication: PubMed 21839732Okamura Y, Yokoi H. Development of a point-of-care assay system for measurement of presepsin (sCD14-ST). Clin Chim Acta. 2011 Nov 20;412(23-24):2157-61. doi: 10.1016/j.cca.2011.07.024. Epub 2011 Aug 3.
- Results publication: PubMed 28875483Wu CC, Lan HM, Han ST, Chaou CH, Yeh CF, Liu SH, Li CH, Blaney GN 3rd, Liu ZY, Chen KF. Comparison of diagnostic accuracy in sepsis between presepsin, procalcitonin, and C-reactive protein: a systematic review and meta-analysis. Ann Intensive Care. 2017 Sep 6;7(1):91. doi: 10.1186/s13613-017-0316-z.
- Individual participant dataSharing planned: No
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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.
Pietro Caironi principal investigator
San Luigi Gonzaga Hospital
Guido Bussone principal investigator
San Luigi Gonzaga Hospital
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 and Covid19, run by San Luigi Gonzaga Hospital at 1 site in Italy.
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 1 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 19 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 Italy. 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 Pietro Caironi (0039 0119026510, pietro.caironi@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate daily variations of presepsin levels as an early marker of VAP in COVID 19 patients (time frame: Time from ICU admission to day 30 or to ICU discharge or to ICU death). 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 NCT04840940, which also lists 22 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 19 Apr 2021.