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Pneumococcal Nasopharyngeal Colonization as Predictor of Community-Acquired Pneumonia (CAP) in Adults With Chronic Diseases.

NCT04944719 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 810

Last updated 2021-06-30

No results posted yet for this study

Summary

Streptococcus pneumoniae (pneumococcus) is a commensal bacterium, often isolated in the nasopharynx of preschool children and older adults with weakened immune systems, a pathogen that remains the leading cause of Community-Acquired Pneumonia (CAP) and invasive pneumococcal disease (IPD) such as Sepsis and Meningitis.

CAP is the sixth leading cause of overall mortality and the first cause of infectious disease in Colombia and the world (Montúfar et al, 2013; GBD, 2016; WHO, 2018), and both its incidence and prevalence have remained stable over the past 3 decades. Likewise, CAP due to S. pnemoniae is the most common cause of lower respiratory tract infections in humans worldwide and is associated with high morbidity and mortality in patients who suffer from it.

Pneumococcus frequently colonizes the nasopharynx of children and adults and, therefore, this condition has been postulated as a risk factor for the development of CAP. There are reports of the effect of nasopharyngeal colonization in infants, but the implications of this colonization in adults, especially adults with chronic comorbidities, are not known.

Additionally, several studies point to a relationship between pathogenicity, colonization capacity, and disease severity according to the infecting pneumococcal serotype. Therefore, it is not known which pneumococcal serotypes are most frequently colonized by adults with chronic diseases (cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), renal disease (RHD), rheumatological disease (MDR), Diabetes Mellitus (DM), among others) and the potential clinical implications of this colonization.

For these reasons, this research aims to study the phenomenon of colonization by pneumococcus in patients with chronic diseases for the development of CAP, and the relationship between the virulence genes of different serotypes and the outcome in invasive pneumococcal disease (IPD).

This study is based on real evidence (from clinical practice) and translational medicine, is prospective-observational, multicenter and cohort type in consecutive patients. Thus, in a first phase the clinical observation of the subjects will be carried out, a second phase of follow-up and sampling in the patients, and a third phase of molecular analysis.

Conditions

  • Streptococcus Pneumoniae Pneumonia
  • Streptococcus Pneumoniae Infection
  • Streptococcus Pneumoniae Infection Invasive
  • Community-acquired Pneumonia

Interventions

DIAGNOSTIC_TEST

nasopharyngeal aspirate

nasopharyngeal aspirate to determinate colonization by streptococcus pneumoniae

Sponsors & Collaborators

  • Universidad de la Sabana

    lead OTHER

Principal Investigators

  • Claudia M Poveda, MD, Spc., Fellow · Fundación Clinica Abood Shaio

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-02-28
Completion
2022-12-01

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04944719 on ClinicalTrials.gov