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

NCT ID: NCT04944823

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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This is a prospective, translational (T0-T2), multicenter, observational, cohort study of consecutive patients with a first clinical phase, where the collection of different types of samples (Bronco alveolar lavage, blood, nasopharyngeal swab, secretion orotracheal and rectal swabbing) at the start of mechanical ventilation, on day 3 and before extubation and another stage of molecular analysis in human samples collected where by different types of techniques such as: characterization of the 16S ribosomal unit, ELISA, time PCR real, concentration and cell discrimination techniques, we will characterize the microbiological, immunological and cellular changes that condition the development of coinfection.

Descriptive analytical studies, techniques, and parametric and nonparametric tests will be used to explore diagnostic, microbiological, or subgroup differences, as well as clinical outcomes. Independent predictors and associated hazard ratios with 95% confidence intervals will be reported. A two-tailed p value less than 0.05 will be considered statistically significant.

Conditions

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Covid19 SARS-CoV Infection

Keywords

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pulmonary microbiome SARS-CoV Infection Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with COVID 19 infection who develop bacterial coinfection.

Follow-up for 24 months

Clinical follow-up for 24 months

Intervention Type OTHER

Sampling and clinical follow-up for 24 months

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

Follow-up for 24 months

Clinical follow-up for 24 months

Intervention Type OTHER

Sampling and clinical follow-up for 24 months

Interventions

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Clinical follow-up for 24 months

Sampling and clinical follow-up for 24 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de la Sabana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinica Universidad De La Sabana

Chía, Cundinamarca, Colombia

Site Status

Countries

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Colombia

Central Contacts

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Luis F Reyes, MD

Role: CONTACT

Phone: +57 3175130128

Email: [email protected]

Ingrid G Bustos, BsC

Role: CONTACT

Phone: +57 3115421277

Email: [email protected]

Facility Contacts

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Luis F Reyes, MD

Role: primary

Ingrid G Bustos, BsC

Role: backup

Other Identifiers

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MED-286-2020

Identifier Type: -

Identifier Source: org_study_id