Characterization Immunology, Biochemical and Lung Microbiome, Correlated With the Ventilation Associated Pneumonia (VAP)

NCT04944823 | Unknown

• 1 other identifier: MED-286-2020
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

SARS-CoV-2, the virus that causes COVID-19, is currently a global public health problem, declared a pandemic by the World Health Organization, which today has more than one million deaths in the world, of which , 30,000 approximately belong to Colombia, being the country number 11 with the highest number of deaths. The most common symptoms related to this disease are fever, cough, dyspnea, myalgia, headache, diarrhea and rhinorrhea. COVID-19 is characterized by immune system dysfunction and hyperinflammation causing acute respiratory distress syndrome, macrophage activation, and coagulopathy. The clinical course for SARS-CoV-2 in most cases is mild, but approximately 14% of cases can be severe. In pneumonia caused by SARS-CoV-2, the lung lining is known to alter the composition of the lung microbiome, in addition to lymphocyte damage that can promote the growth of bacteria to initiate bacterial pneumonia, and it is estimated that the prevalence of coinfection / superinfection reaches 50% among deaths from COVID-19. Coinfection between different microorganisms and SARS-CoV-2 is a serious problem in the COVID-19 pandemic, and there is still little information on this. It is for this reason that the researchs propose to develop this research project that will allow to understand the possible mechanisms associated with the development of bacterial coinfection / superinfection in patients diagnosed with COVID-19, which will allow expanding the panorama of knowledge towards a better and adequate treatment in these patients, as well as detection of biomarkers or clinical phenotypics that may be useful in the diagnosis, based on evidence. It is important to note that these results are of clinical importance since we will try to identify biomarkers or changes in the lung microbiome that allow doctors to early identify patients at risk of developing coinfection and thus initiate early treatments or preventive measures, which allow the improvement of clinical outcomes in patients. Results will be presented in a timely manner at national and international conferences and in peer-reviewed, indexed, high-impact journals.

Conditions

Covid19; SARS-CoV Infection

Keywords

pulmonary microbiome; SARS-CoV Infection; Covid19

Outcome Measures

Primary Outcomes (2)

• Identification of the pulmonary microbiome and changes in microbial diversity in patients with severe COVID.

  To observe the change that occur in the diversity of the pulmonary microbiome in patients with severe COVID, with mechanical ventilation. The pulmonary microbiome will be analyzed at 4 four times during the patient's mechanical ventilation (baseline, 72 hours, fifth day, seventh day or if he/she develops co-infection or superinfection).

  24 months

• Correlation between microbial diversity and host immune response with severe COVID.

  To analyze whether changes in microbial diversity have any association with the host immune response leading to increased susceptibility to co-infection or superinfection during COVID disease.

  24 months

Secondary Outcomes (2)

• Percentage of coinfected/overinfected patients with severe COVID and the diversity of the pulmonary microbiome.

  24 months

• Immunologic or cellular patterns in coinfection or superinfection in patients with severe COVID.

  24 months

Other Outcomes (1)

• Type of specimen and conventional cultures for the diagnosis of coinfection or superinfection in patients with severe COVID.

  24 months

Study Arms (2)

Patients with COVID 19 infection who develop bacterial coinfection.

Follow-up for 24 months

Other: Clinical follow-up for 24 months

Patients with COVID 19 infection who do not develop bacterial coinfection.

Follow-up for 24 months

Other: Clinical follow-up for 24 months

Interventions

Clinical follow-up for 24 months OTHER

Sampling and clinical follow-up for 24 months

Patients with COVID 19 infection who develop bacterial coinfection.; Patients with COVID 19 infection who do not develop bacterial coinfection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients admitted to the Intensive Care Unit of the Clínica Universitaria de la Sabana, with a diagnosis of COVID-19 by RT-PCR, who require invasive mechanical ventilation due to respiratory failure as a result of the infection and who approve their participation in the study. It is important to highlight that these patients are sedated and cannot agree to participate in the study; therefore, the patient's relatives or legal representative will be in charge of defining the participation of the relative in the study.

You may qualify if:

• Patients admitted to the ICU, COVID-19 positive by RT-PCR, who require assisted mechanical ventilation.
• Adult patients over 18 years of age.
• Patients who agree to participate in the study and sign the informed consent form (family members or legal representative).
• Patients in whom the identification of the causative agent of coinfection is attempted within the first 48 hours of hospitalization.

You may not qualify if:

• Patient on mechanical ventilation for more than 24 hours without being evaluated for study entry.
• Patient who was treated with antibiotics 7 days prior to hospitalization or time of assessment for the study.
• Pregnant or breastfeeding patients.
• People who belong to population groups with increased vulnerability such as, for example, prison population, minors detained in orphanages or people in street situations.
• No research procedure, clinical or paraclinical, or taking of clinical information or biological samples will be performed before the patient or his/her legal representative agrees to participate in the study and signs the informed consent form.

Sponsors & Collaborators

• Universidad de la Sabana: lead

Study Sites (1)

Clinica Universidad De La Sabana

Chía, Cundinamarca, Colombia

Location

Biospecimen

Retention: SAMPLES WITH DNA

orotracheal secretion Rectal swab bronchoalveolar lavage

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Luis F Reyes, MD

CONTACT

+57 3175130128; luis.reyes5@unisabana.edu.co

Ingrid G Bustos, BsC

CONTACT

+57 3115421277; ingrid.bustos2@unisabana.edu.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 30, 2021
• Study Start: July 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)