Respiration, ArtificialCOVIACSNCT04819165
Healthcare-associated Infections in Severe COVID-19 During 2020
An observational study of Respiration, Artificial and COVID-19, run by Sanatorio Anchorena San Martin at 1 site in Argentina.
Trial summary
In patients who develop ARDS due to SARS-CoV-2 (CARDS), a longer duration of invasive mechanical ventilation (IMV) and ICU stay has been reported compared to ARDS not associated with SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial, COVID-19, Health Care Associated Infection
- What is being tested?
- COVID-19
- How many people
- 252 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Mar 2020to 31 Jan 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 admitted to ICU who required invasive mechanical ventilation during the COVID-19 pandemic from March to December 2020.
Who may be able to join
- All patients older than 18 years admitted to the intensive care unit of the Anchorena San Martín Clinic who required invasive mechanical ventilation for more than 24 hours in a period between March 2020 and December 2020 were included in the analysis.
Who cannot join
- All patients who presented incomplete data in the follow-up sheets were excluded.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Sanatorio Anchorena de San Martin
San Martín, Buenos Aires, B1650CQU
About this study
Official title: Healthcare-associated Infections in Severe COVID-19 Patients Whit Mechanical Ventilation During 2020
In patients who develop ARDS due to SARS-CoV-2 (CARDS), a longer duration of invasive mechanical ventilation (IMV) and ICU stay has been reported compared to ARDS not associated with SARS-CoV-2. Consequently, the days of stay in ICU increase Identifying the risk factors associated with the development of this complication and developing measures aimed at its prevention could have a favorable impact on the clinical course of seriously ill patients.
Read the detailed description
The rate of catheter-associated bacteremia is 3.78 / 1000 days central venous catheters in polyvalent ICUs.
Some studies suggest that in the context of this pandemic, infections associated with health care have increased, although there are few data referring to Latin America.
The objective of this study is to analyze the incidence of health care associated infections in adult patients on invasive mechanical ventilation with confirmed COVID-19 diagnosis and negative COVID-19 admitted to the Intensive Care Unit of the Anchorena San Martín Clinic, San Martín, Buenos Aires.
- Being tested
- COVID-19
- Medical subject headings
- Respiratory Aspiration, COVID-19, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19Other
Impact of covid-19 on infections associated with health care devices.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | Patients with invasive mechanical ventilation admitted to the Intensive Care Unit (UCI) of the Anchorena San Martín Clinic, San Martín, Buenos Aires with confirmed COVID-19 diagnosis (positive polymerase chain reaction in nasopharyngeal swab). Receives: Other: COVID-19 | |
| non COVID-19 patients | Patients with invasive mechanical ventilation admitted to the Intensive Care Unit (UCI) of the Anchorena San Martín Clinic, San Martín, Buenos Aires with negative COVID-19 diagnosis (positive polymerase chain reaction in nasopharyngeal swab). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of health care associated infections in each group.
Measured: March to December 2020
Secondary outcomes (5)
The most frequent pathogens in this population associated with Incidence of health care associated infections.
Measured: March to December 2020
Possible factors associated with Incidence of health care associated infections.
Measured: March to December 2020
mortality in UCI
Measured: March to December 2020
Days of ICU stay
Measured: March to December 2020
Days of mechanical ventilation
Measured: March to December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Mar 2020
- Primary completion31 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies 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
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanatorio Anchorena San Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matias Accoce, Sanatorio Anchorena San Martin
- Investigators
- matias accoce, Principal investigator, SAnchorena San Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819165
- Sponsor's protocol ID
- 5/2021
- Acronym
- COVIACS
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tufan A, Avanoglu Guler A, Matucci-Cerinic M. COVID-19, immune system response, hyperinflammation and repurposing antirheumatic drugs. Turk J Med Sci. 2020 Apr 21;50(SI-1):620-632. doi: 10.3906/sag-2004-168.
PubMed 32299202Ripa M, Galli L, Poli A, Oltolini C, Spagnuolo V, Mastrangelo A, Muccini C, Monti G, De Luca G, Landoni G, Dagna L, Clementi M, Rovere Querini P, Ciceri F, Tresoldi M, Lazzarin A, Zangrillo A, Scarpellini P, Castagna A; COVID-BioB study group. Secondary infections in patients hospitalized with COVID-19: incidence and predictive factors. Clin Microbiol Infect. 2021 Mar;27(3):451-457. doi: 10.1016/j.cmi.2020.10.021. Epub 2020 Oct 24.
PubMed 33223114Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Kalanuria AA, Ziai W, Mirski M. Ventilator-associated pneumonia in the ICU. Crit Care. 2014 Mar 18;18(2):208. doi: 10.1186/cc13775. No abstract available.
PubMed 25029020Rouze A, Nseir S. Continuous control of tracheal cuff pressure for the prevention of ventilator-associated pneumonia in critically ill patients: where is the evidence? Curr Opin Crit Care. 2013 Oct;19(5):440-7. doi: 10.1097/MCC.0b013e3283636b71.
PubMed 23856895Duszynska W, Rosenthal VD, Szczesny A, Woznica E, Ulfik K, Ostrowska E, Litwin A, Kubler A. Urinary tract infections in intensive care unit patients - a single-centre, 3-year observational study according to the INICC project. Anaesthesiol Intensive Ther. 2016;48(1):1-6. doi: 10.5603/AIT.2016.0001.
PubMed 26966105Rosenthal VD, Dwivedy A, Calderon ME, Esen S, Hernandez HT, Abouqal R, Medeiros EA, Espinoza TA, Kanj SS, Gikas A, Barnett AG, Graves N; International Nosocomial Infection Control Consortium (INICC) Members. Time-dependent analysis of length of stay and mortality due to urinary tract infections in ten developing countries: INICC findings. J Infect. 2011 Feb;62(2):136-41. doi: 10.1016/j.jinf.2010.12.004. Epub 2010 Dec 17.
PubMed 21168440Rouze A, Martin-Loeches I, Povoa P, Makris D, Artigas A, Bouchereau M, Lambiotte F, Metzelard M, Cuchet P, Boulle Geronimi C, Labruyere M, Tamion F, Nyunga M, Luyt CE, Labreuche J, Pouly O, Bardin J, Saade A, Asfar P, Baudel JL, Beurton A, Garot D, Ioannidou I, Kreitmann L, Llitjos JF, Magira E, Megarbane B, Meguerditchian D, Moglia E, Mekontso-Dessap A, Reignier J, Turpin M, Pierre A, Plantefeve G, Vinsonneau C, Floch PE, Weiss N, Ceccato A, Torres A, Duhamel A, Nseir S; coVAPid study Group. Relationship between SARS-CoV-2 infection and the incidence of ventilator-associated lower respiratory tract infections: a European multicenter cohort study. Intensive Care Med. 2021 Feb;47(2):188-198. doi: 10.1007/s00134-020-06323-9. Epub 2021 Jan 3.
PubMed 33388794
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare-associated Infections in Severe COVID-19 Patients Whit Mechanical Ventilation During 2020
- ClinicalTrials.gov ID
- NCT04819165
- Acronym / sponsor ID
- COVIACS / 5/2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Sanatorio Anchorena San MartinUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 26 Mar 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.
In patients who develop ARDS due to SARS-CoV-2 (CARDS), a longer duration of invasive mechanical ventilation (IMV) and ICU stay has been reported compared to ARDS not associated with SARS-CoV-2. Consequently, the days of stay in ICU increase Identifying the risk factors associated with the development of this complication and developing measures aimed at its prevention could have a favorable impact on the clinical course of seriously ill patients.
Detailed description
The rate of catheter-associated bacteremia is 3.78 / 1000 days central venous catheters in polyvalent ICUs.
Some studies suggest that in the context of this pandemic, infections associated with health care have increased, although there are few data referring to Latin America.
The objective of this study is to analyze the incidence of health care associated infections in adult patients on invasive mechanical ventilation with confirmed COVID-19 diagnosis and negative COVID-19 admitted to the Intensive Care Unit of the Anchorena San Martín Clinic, San Martín, Buenos Aires.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients | – | Other: COVID-19Patients with invasive mechanical ventilation admitted to the Intensive Care Unit (UCI) of the Anchorena San Martín Clinic, San Martín, Buenos Aires with confirmed COVID-19 diagnosis (positive polymerase chain reaction in nasopharyngeal swab). |
| non COVID-19 patients | – | –Patients with invasive mechanical ventilation admitted to the Intensive Care Unit (UCI) of the Anchorena San Martín Clinic, San Martín, Buenos Aires with negative COVID-19 diagnosis (positive polymerase chain reaction in nasopharyngeal swab). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to ICU who required invasive mechanical ventilation during the COVID-19 pandemic from March to December 2020.
Key inclusion criteria (1 listed)
- All patients older than 18 years admitted to the intensive care unit of the Anchorena San Martín Clinic who required invasive mechanical ventilation for more than 24 hours in a period between March 2020 and December 2020 were included in the analysis.
Key exclusion criteria (1 listed)
- All patients who presented incomplete data in the follow-up sheets were excluded.
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 |
|---|---|---|
| COVID-19Impact of covid-19 on infections associated with health care devices. | Other | COVID-19 patients |
Primary outcome
Incidence of health care associated infections in each group.
Time frame: March to December 2020
5 secondary outcomes
The most frequent pathogens in this population associated with Incidence of health care associated infections.
Time frame: March to December 2020
Possible factors associated with Incidence of health care associated infections.
Time frame: March to December 2020
mortality in UCI
Time frame: March to December 2020
Days of ICU stay
Time frame: March to December 2020
Days of mechanical ventilation
Time frame: March to December 2020
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 26 Mar 2021.
- Results publication: PubMed 32299202Tufan A, Avanoglu Guler A, Matucci-Cerinic M. COVID-19, immune system response, hyperinflammation and repurposing antirheumatic drugs. Turk J Med Sci. 2020 Apr 21;50(SI-1):620-632. doi: 10.3906/sag-2004-168.
- Results publication: PubMed 33223114Ripa M, Galli L, Poli A, Oltolini C, Spagnuolo V, Mastrangelo A, Muccini C, Monti G, De Luca G, Landoni G, Dagna L, Clementi M, Rovere Querini P, Ciceri F, Tresoldi M, Lazzarin A, Zangrillo A, Scarpellini P, Castagna A; COVID-BioB study group. Secondary infections in patients hospitalized with COVID-19: incidence and predictive factors. Clin Microbiol Infect. 2021 Mar;27(3):451-457. doi: 10.1016/j.cmi.2020.10.021. Epub 2020 Oct 24.
- Results publication: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Results publication: PubMed 25029020Kalanuria AA, Ziai W, Mirski M. Ventilator-associated pneumonia in the ICU. Crit Care. 2014 Mar 18;18(2):208. doi: 10.1186/cc13775. No abstract available.
- Results publication: PubMed 23856895Rouze A, Nseir S. Continuous control of tracheal cuff pressure for the prevention of ventilator-associated pneumonia in critically ill patients: where is the evidence? Curr Opin Crit Care. 2013 Oct;19(5):440-7. doi: 10.1097/MCC.0b013e3283636b71.
- Results publication: PubMed 26966105Duszynska W, Rosenthal VD, Szczesny A, Woznica E, Ulfik K, Ostrowska E, Litwin A, Kubler A. Urinary tract infections in intensive care unit patients - a single-centre, 3-year observational study according to the INICC project. Anaesthesiol Intensive Ther. 2016;48(1):1-6. doi: 10.5603/AIT.2016.0001.
- Results publication: PubMed 21168440Rosenthal VD, Dwivedy A, Calderon ME, Esen S, Hernandez HT, Abouqal R, Medeiros EA, Espinoza TA, Kanj SS, Gikas A, Barnett AG, Graves N; International Nosocomial Infection Control Consortium (INICC) Members. Time-dependent analysis of length of stay and mortality due to urinary tract infections in ten developing countries: INICC findings. J Infect. 2011 Feb;62(2):136-41. doi: 10.1016/j.jinf.2010.12.004. Epub 2010 Dec 17.
- Results publication: PubMed 33388794Rouze A, Martin-Loeches I, Povoa P, Makris D, Artigas A, Bouchereau M, Lambiotte F, Metzelard M, Cuchet P, Boulle Geronimi C, Labruyere M, Tamion F, Nyunga M, Luyt CE, Labreuche J, Pouly O, Bardin J, Saade A, Asfar P, Baudel JL, Beurton A, Garot D, Ioannidou I, Kreitmann L, Llitjos JF, Magira E, Megarbane B, Meguerditchian D, Moglia E, Mekontso-Dessap A, Reignier J, Turpin M, Pierre A, Plantefeve G, Vinsonneau C, Floch PE, Weiss N, Ceccato A, Torres A, Duhamel A, Nseir S; coVAPid study Group. Relationship between SARS-CoV-2 infection and the incidence of ventilator-associated lower respiratory tract infections: a European multicenter cohort study. Intensive Care Med. 2021 Feb;47(2):188-198. doi: 10.1007/s00134-020-06323-9. Epub 2021 Jan 3.
- 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.
matias accoce principal investigator
SAnchorena San Martin
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 Respiration, Artificial and COVID-19, run by Sanatorio Anchorena San Martin at 1 site in Argentina.
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 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 26 Mar 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 Argentina. 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?
Incidence of health care associated infections in each group. (time frame: March to December 2020). 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 NCT04819165, which also lists 8 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 26 Mar 2021.