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

NCT04944719 | Unknown

• 1 other identifier: MED-285-2020
• Study Type: observational
• Target: 810
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Streptococcus pneumoniae (neumococo); Community Acquired Pneumonia (CAP); Nasopharyngeal colonization; Serotypes; Adults with Chronic Diseases

Outcome Measures

Primary Outcomes (1)

• Nasopharyngeal colonization by streptococcus pneumoniae

  Definition: Colonization by S. pneumoniae in the nasopharyngeal tissue will be determined when using the traditional culture method and molecular biology (real time - PCR), the pneumococcus growth with a density of more than 10 (3) Colony-forming units (CFU). Then, using molecular biology (MS-PCR) and reaction quellung, S. pneumoniae isolated will be further characterized to determine the pneumococcal serotypes. Outcome measure: • Pneumococcal nasopharyngeal colonization prevalence of period in Adults With Chronic Diseases (PNCP) : PNCP = Pneumococcal isolates with bacteriological positive testing done during the study period / Total number of subjects enrolled in the study period. Statistic analysis: categorical variables will be expressed as counts (percentages), will be compared between groups using the Chi-squared test.

  2 years

Secondary Outcomes (2)

• Risk of Development of community-acquired pneumonia (CAP)

  2 years

• Risk of Development of Invasive Pneumococcal Disease (IPD)

  2 years

Study Arms (2)

chronically ill adult patients colonized by streptococcus pneumoniae

At baseline, adult patients with chronic disease who are colonized with Streptococcus pneumoniae will be identified. Then, after determining the colonized subjects, monthly telephone follow-up and clinical outcome will be determined to identify patients who develop CAP or IPD. Additionally, follow-up samples similar to baseline will be taken to determine colonization by other serotypes or resolution of colonization status in these patients.

Diagnostic Test: nasopharyngeal aspirate

chronically ill adult patients not colonized by streptococcus pneumoniae

Subjects who are not colonized with S. pneumoniae will be followed by monthly telephone follow-up and clinical outcome will be determined to identify patients who develop CAP or IPD. Additionally, follow-up samples similar to baseline will be collected every six months to determine colonization during the follow-up time in the study.

Diagnostic Test: nasopharyngeal aspirate

Interventions

nasopharyngeal aspirate DIAGNOSTIC_TEST

nasopharyngeal aspirate to determinate colonization by streptococcus pneumoniae

chronically ill adult patients colonized by streptococcus pneumoniae; chronically ill adult patients not colonized by streptococcus pneumoniae

Eligibility Criteria

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

Study Population

All consecutive adult patients admitted to the outpatient service of 2 clinics in the city of Bogota D. C and at the Clínica Universitaria de la Sabana, who have been diagnosed with chronic diseases such as Heart Failure (HF), Benign Prostatic Hyperplasia (BPH), Chronic Cardiac Arrhythmia (CCA), Rheumatic Disease (RHD), bronchiectasis not related to cystic fibrosis, chronic obstructive pulmonary disease (COPD), among others; patients without evidence of pneumonia at study entry and who voluntarily approve their participation in the study will be recruited

You may qualify if:

• \> 18 years of age or older.
• Patients attending cardiology, pulmonology, endocrinology or rheumatology programs at the centers participating in the study.
• Patients with vaccination information available and confirmed in the medical records (in addition it will be confirmed at the time of the interview during the study enrollment consultation).
• Patients who sign the informed consent approved for this purpose.

You may not qualify if:

• Patients with a diagnosis of CAP prior to 90 days from the time of enrollment in the study.
• Patients admitted to hospital during the 7 days prior to enrollment in the study.
• Patients with any clinical or manifest limitation to provide biological samples.

Sponsors & Collaborators

• Universidad de la Sabana: lead

Study Sites (1)

Clinica Universidad De La Sabana

Chía, Cundinamarca, Colombia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, nasopharyngeal aspirate, urine

MeSH Terms

Conditions

Pneumonia; Pneumococcal Infections; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Community-Acquired Infections

Study Officials

• Claudia M Poveda, MD, Spc., Fellow

  Fundación Clinica Abood Shaio

  STUDY CHAIR

Central Study Contacts

Luis F Reyes, MD, PhD

CONTACT

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

Julian A Lozada, BsC, MIg

CONTACT

+57 3187950924; julianroar@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: December 1, 2020
• Primary Completion: February 28, 2022
• Study Completion: December 1, 2022
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)