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Healthcare-associated Infections in Severe COVID-19 During 2020 (COVIACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04819165
Recruitment Status : Completed
First Posted : March 26, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Matias Accoce, Sanatorio Anchorena San Martin

Tracking Information
First Submitted Date March 25, 2021
First Posted Date March 26, 2021
Last Update Posted Date March 26, 2021
Actual Study Start Date March 1, 2020
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2021)
Incidence of health care associated infections in each group. [ Time Frame: March to December 2020 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 25, 2021)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Healthcare-associated Infections in Severe COVID-19 During 2020
Official Title Healthcare-associated Infections in Severe COVID-19 Patients Whit Mechanical Ventilation During 2020
Brief 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. 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients admitted to ICU who required invasive mechanical ventilation during the COVID-19 pandemic from March to December 2020.
Condition
  • Respiration, Artificial
  • COVID-19
  • Health Care Associated Infection
Intervention Other: COVID-19
Impact of covid-19 on infections associated with health care devices.
Study Groups/Cohorts
  • 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).
    Intervention: 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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 25, 2021)
252
Original Actual Enrollment Same as current
Actual Study Completion Date January 31, 2021
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • All patients who presented incomplete data in the follow-up sheets were excluded.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina
Removed Location Countries  
 
Administrative Information
NCT Number NCT04819165
Other Study ID Numbers 5/2021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Matias Accoce, Sanatorio Anchorena San Martin
Study Sponsor Sanatorio Anchorena San Martin
Collaborators Not Provided
Investigators
Principal Investigator: matias accoce SAnchorena San Martin
PRS Account Sanatorio Anchorena San Martin
Verification Date March 2021