NCT04944719: CAP

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

Status unknown Last updated 30 June 2021

What this trial tests

trial testing nasopharyngeal aspirate in Streptococcus Pneumoniae Pneumonia in 810 participants. Status unknown.

Timeline

1 December 2020

Primary endpoint
28 February 2022

1 December 2022

Quick facts

Lead sponsor	Universidad de la Sabana
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	810
Start date	1 December 2020
Primary completion	28 February 2022
Estimated completion	1 December 2022
Sites	1 location across Colombia

Drugs / interventions tested

• nasopharyngeal aspirate

Conditions studied

• Streptococcus Pneumoniae Pneumonia — all drugs for Streptococcus Pneumoniae Pneumonia →
• Streptococcus Pneumoniae Infection — all drugs for Streptococcus Pneumoniae Infection →
• Streptococcus Pneumoniae Infection Invasive — all drugs for Streptococcus Pneumoniae Infection Invasive →
• Community-acquired Pneumonia — all drugs for Community-acquired Pneumonia →

Sponsor

Universidad de la Sabana

Who can join

18 and older, any sex, with Streptococcus Pneumoniae Pneumonia or Streptococcus Pneumoniae Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.