Pneumococcal Community-Acquired Pneumonia Requiring Hospitalization Among Colombian Adults

NCT07354425 | Completed DMC

• 1 other identifier: MED-357-2023
• Study Type: observational
• Target: 688
• Locations: 1 country
• Sites: 11

Brief Summary

Pneumococcal Community-Acquired Pneumonia Requiring Hospitalization Among Adults in Colombia (Pneumo-CAP Colombia) This study aims to learn more about pneumococcal community-acquired pneumonia (CAP) caused by Streptococcus pneumoniae among adults hospitalized in 11 hospitals in the Sabana Centro region of Colombia. The study will describe the characteristics of adults with CAP, estimate pneumococcal CAP prevalence in the area, and examine the specific serotypes of S. pneumoniae causing this infection. This research is essential for understanding which microorganism is the most prevalent cause of CAP in the region, whether pneumococcal vaccines included in governmental vaccination programs protect adults, which specific pneumococcal serotypes are circulating, and which available vaccine will best protect people against pneumococcal CAP. The study will be conducted at 11 hospitals in the Sabana Centro region and will collect data over 2 years. The study will gather detailed information on each patient's condition, including symptoms, medical history, and outcomes such as death or the need for intensive care.

Conditions

Community Acquired Pneumonia (CAP); Pneumococcal Pneumonia

Keywords

Pneumo-CAP; Community Acquired Pneumonia; CAP; Pneumococcal Pneumonia; Colombia

Outcome Measures

Primary Outcomes (3)

• Incidence of Pneumococcal Community-Acquired Pneumonia (CAP)

  This outcome captures how many adults are hospitalized with community-acquired pneumonia caused by Streptococcus pneumoniae, including both bacteremic (positive blood culture) and non-bacteremic cases (positive respiratory sample, urinary antigen test, or PCR). How it will be measured Pneumococcal CAP cases will be identified through routinely collected microbiological results: Blood cultures Respiratory cultures (sputum, BAL, tracheal aspirate) Urinary pneumococcal antigen test PCR/NAAT panels detecting S. pneumoniae All confirmed cases will be counted and divided by the total number of CAP hospitalizations (or by the catchment population, if applicable) to calculate the incidence.

  The incidence will be measured throughout the whole study period (from study start to study end), with cases recorded at the time of hospital admission for CAP. (2 years)(Jun-2022 to Nov-2025)

• Prevalence of Pneumococcal Serotypes

  This outcome describes the frequency with which pneumococcal serotypes covered by the 15-valent conjugate vaccine (PCV15) appear among adults hospitalized with community-acquired pneumonia. How it will be measured All patients with pneumococcal CAP who undergo serotyping will be reviewed. Each serotype identified will be classified as either a PCV15 serotype or a non-PCV15 serotype. The prevalence will be determined by counting the number of pneumococcal CAP cases caused by serotypes included in PCV15, compared with the total number of cases with available serotype information.

  Serotypes will be assessed at the time of hospitalization, and the prevalence will be evaluated across the entire study period. (2 years, Jun-2022 until Nov-2025)

• Prevalence of Pneumococcal CAP Among Hospitalized Adults

  This outcome describes the prevalence of community-acquired pneumococcal pneumonia among adults requiring hospitalization. How it will be measured All hospitalized adults diagnosed with CAP will be reviewed to determine which cases have laboratory confirmation of Streptococcus pneumoniae through blood cultures, respiratory samples, urinary antigen testing, or molecular assays. The prevalence will be determined by counting the number of CAP cases identified as pneumococcal among all CAP hospitalizations.

  Pneumococcal CAP cases will be identified at the time of hospital admission, and prevalence will be assessed for the entire study period.(2 years, Jun-2022 until Nov-2025)

Secondary Outcomes (5)

• Severity of Pneumococcal CAP

  Recorded on day 1 ( baseline) and/or at ICU admission when applicable.

• Mortality

  from recruitment until 3 months post-discharge

• ICU Admission

  Recorded on day of ICU admission (during index hospitalization)

• Variation in Quality of Life

  Recorded on day 1 ( baseline) and on day 27 after discharge and day 90 after discharge (From recruitment until 3 month post-discharge)

• Dyspnea persistence

  Dyspnea will be assessed at the time points defined on Day 1, Day 27 after discharge, and Day 90 after discharge. From baseline until 3 months post-discharge.

Eligibility Criteria

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

Study Population

The study population will consist of adults aged 18 years or older hospitalized with community-acquired pneumonia (CAP) in the Sabana Centro region of Colombia. This region includes 11 municipalities around Bogotá and represents a diverse socio-economic and demographic population with a well-organized healthcare system.

You may qualify if:

• (1) Age ≥ 18 years old.
• (2) Hospitalized at one of the hospitals of Sabana Centro Region, including both in-patient and observation status stay.
• (3) Clinical signs and/or symptoms of an acute respiratory illness, as defined by ≥ 1 of the
• following:
• New or worsening shortness of breath in the past 7 days
• New or worsening cough in the past 7 days
• New or worsening sputum production in the past 7 days
• New or worsening chest pain in the past 7 days
• Tachypnea to respiratory rate ≥ 22 breaths/min, not known to be chronic
• Hypoxia to SpO2 ≤ 92% not known to be chronic
• Initiation of invasive or non-invasive mechanical ventilation
• (4) Clinical signs and/or symptoms of an acute infection, as defined by ≥ 1 of the following:
• Body temperature ≥ 38º C (100.4º F) or ≤ 35.5º C (95.9º F)
• Reported fever, chills, or feeling feverish at home without explicit documentation of a fever within the past 7 days
• White blood cell count \> 10.7 or \< 3.9 thousand cells/mcL-C-reactive protein \> 10 mg/L

You may not qualify if:

• (1) Enrollment in this study within the past 90 days.
• (3) Inability to obtain consent from patient or surrogate for this study within 48 hours of hospital admission (including time at a transferring hospital before admission at a study hospital).
• (4) Inability or unwillingness of the patient to provide any of the samples (Blood, Urine, and Sputum) within 48 hours of hospital admission (including time at a transferring hospital before admission at a study hospital).
• (5) Non-pneumonia illness completely explains the patient's acute symptoms. Alternative non-pneumonia illnesses could include pulmonary embolism, acute heart failure, lung cancer, and pulmonary hemorrhage.

Sponsors & Collaborators

• Universidad de la Sabana: lead
• Clínica Universidad de La Sabana: collaborator
• Universidad de La Sabana, Colombia: collaborator

Study Sites (11)

Clinica de Marly Jorge Cavelier Gaviria SAS

Chía, Cundinamarca, 250002, Colombia

Location

Clinica Universidad de La Sabana

Chía, Cundinamarca, 250002, Colombia

Location

ESE Hospital San Antonio de Chia

Chía, Cundinamarca, 250002, Colombia

Location

Centro Medico San Luis Clinica Quirurgica SAS

Cajicá, Colombia

Location

ESE Hospital San Vicente de Paul Nemocon

Nemocón, Colombia

Location

ESE Hospital divino Salvador Sopo

Sopó, Colombia

Location

ESE Hospital Nuestra Señora del Carmen de Tabio

Tabio, Colombia

Location

ESE Hospital Santa Rosa de Tenjo

Tenjo, Colombia

Location

Hospital Nuestra Señora del Transito de Tocancipa

Tocancipá, Colombia

Location

Hospital Universitario de la Samaritana Regional

Zipaquirá, Colombia

Location

Hospital Universitario de la Samaritana sede Funcional

Zipaquirá, Colombia

Location

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Biospecimen

Retention: SAMPLES WITH DNA

Blood Urine Sputum

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia, Pneumococcal

Condition Hierarchy (Ancestors)

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

Study Officials

• Luis F Reyes, MD,PhD, MsC

  Universidad de la Sabana

  PRINCIPAL INVESTIGATOR

• Cristian C Serrano, MD, cPhD

  Clinica Universidad de La Sabana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, MSc Principal Investigator

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: January 21, 2026
• Study Start: June 28, 2022
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CO (11)