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Community Acquired Pneumonia (CAP)PneumoCAPNCT07354425

Pneumococcal Community-Acquired Pneumonia Requiring Hospitalization Among Colombian Adults

An observational study of Community Acquired Pneumonia (CAP) and Pneumococcal Pneumonia, run by Universidad de la Sabana at 11 sites in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
688 participants
Where
11 sitesColombia
Study dates
28 Jun 2022to 25 Feb 2025
How long will I take part?
4 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • (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
Show all 20Show fewer
  • -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
  • -Altered mental status
  • (5) Radiologic evidence of pneumonia interpreted by a radiologist, defined as ≥ 1 of the following findings on chest x-ray (CXR), computed tomography (CT), or lung ultrasound completed within 48 hours before or after hospital admission:
  • -Pulmonary infiltrate not known to be chronic
  • -Pulmonary opacity is not known to be chronic (including ground-glass opacities on CT)
  • -Pulmonary consolidation is not known to be

Who cannot join

  • (1) Enrollment in this study within the past 90 days.
  • (2) Development of pneumonia (as defined in the inclusion criteria) more than 48 hours after hospital admission (pneumonia developed 48 hours after admission will be considered hospital-acquired pneumonia).
  • (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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Colombia11 sites

  • Centro Medico San Luis Clinica Quirurgica SAS

    Cajicá

  • Clinica de Marly Jorge Cavelier Gaviria SAS

    Chía, Cundinamarca, 250002

  • Clinica Universidad de La Sabana

    Chía, Cundinamarca, 250002

  • ESE Hospital San Antonio de Chia

    Chía, Cundinamarca, 250002

  • ESE Hospital San Vicente de Paul Nemocon

    Nemocón

  • ESE Hospital divino Salvador Sopo

    Sopó

  • ESE Hospital Nuestra Señora del Carmen de Tabio

    Tabio

  • ESE Hospital Santa Rosa de Tenjo

    Tenjo

  • Hospital Nuestra Señora del Transito de Tocancipa

    Tocancipá

  • Hospital Universitario de la Samaritana Regional

    Zipaquirá

  • Hospital Universitario de la Samaritana sede Funcional

    Zipaquirá

Other trials in Colombia

About this study

Official title: Pneumococcal Community-Acquired Pneumonia Requiring Hospitalization Among Colombian Adults (Pneumo-CAP Colombia)

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.

Read the detailed description

This prospective, multicenter surveillance study aims to provide a detailed understanding of pneumococcal community-acquired pneumonia (CAP), a leading cause of hospitalization and mortality, in adults in the Sabana Centro region of Colombia. Pneumococcal CAP, caused by the bacterium Streptococcus pneumoniae, remains a significant global health burden despite widespread vaccination programs. The study will investigate the incidence, prevalence, and serotype distribution of pneumococcal CAP, with a particular focus on strains included in the 15-valent pneumococcal conjugate vaccine (PCV15).

The study's objectives will help inform future vaccine development, public health policies, and the clinical management of pneumococcal infections in adult populations, particularly in low- and middle-income countries (LMICs), where vaccine coverage and disease burden remain concerns.

Study Goals and Objectives:

The study has four primary objectives:

  1. To describe the demographic and clinical characteristics of adults ≥18 years hospitalized with pneumococcal CAP in the Sabana Centro region, including both bacteremic and non-bacteremic cases of the infection.
  2. To determine the prevalence of pneumococcal CAP among patients requiring hospitalization for CAP in the Sabana Centro region of Colombia.
  3. To determine the prevalence of pneumococcal serotypes included in the PCV15 vaccine in hospitalized adults with pneumococcal CAP, including both bacteremic and non-bacteremic cases.
  4. To estimate the incidence of pneumococcal CAP that requires hospitalization and the contribution of PCV15 serotypes to the disease burden in the region. The study will also explore secondary objectives, including the association between pneumococcal positivity and severe clinical outcomes like ICU admission, mechanical ventilation, vasopressor use, and mortality. Study Design: This is a prospective, observational, multicenter study with active surveillance. The research will take place at 11 hospitals across the Sabana Centro region, including both public and private institutions. The study will collect data over two years, with a recruitment period of one year and a follow-up period of up to three months post-discharge. Inclusion and Exclusion Criteria: Inclusion Criteria: -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
  • Altered mental status
  • 5. Radiologic evidence of pneumonia interpreted by a radiologist, defined as ≥ 1 of the following findings on chest x-ray (CXR), computed tomography (CT), or lung ultrasound completed within 48 hours before or after hospital admission:
  • Pulmonary infiltrate not known to be chronic
  • Pulmonary opacity is not known to be chronic (including ground-glass opacities on CT)
  • Pulmonary consolidation is not known to be Exclusion Criteria: -1. Enrollment in this study within the past 90 days. -2. Development of pneumonia (as defined in the inclusion criteria) more than 48 hours after hospital admission (pneumonia developed 48 hours after admission will be considered hospital-acquired pneumonia). -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. o- Key Outcomes and Data Collection: The study will track multiple outcomes, including: o- Incidence of pneumococcal CAP (overall, and by specific serotypes included in PCV15). o- Prevalence of pneumococcal serotypes, particularly those contained in PCV15. o- Clinical outcomes such as:
  • Mortality (hospital mortality and 3-month post-discharge mortality)
  • ICU admission
  • Need for invasive mechanical ventilation
  • Use of vasopressors
  • Duration of hospital and ICU stay o- Quality of life measures using the EQ-5D-5L and mMRC scales, assessed at baseline, 1 month, and 3 months post-discharge. o- Laboratory Tests and Procedures: The study will use a combination of diagnostic methods to detect S. pneumoniae and characterize the pneumococcal strains involved, including:
  • Urine antigen tests.
  • Blood cultures.
  • Sputum cultures.
  • Real-time PCR for molecular detection of S. pneumoniae in blood and sputum samples. In addition, the study will collect data on the antimicrobial resistance patterns of the isolated pneumococcal strains, evaluating resistance to penicillins, macrolides, and other antibiotic classes. o-Data Management and Analysis: All data will be collected electronically through the RedCap platform, a secure, web-based system. The data will be analyzed using descriptive statistics for demographic and clinical characteristics, as well as incidence and prevalence rates of pneumococcal CAP. Multivariate regression models will be used to assess associations between pneumococcal infection and clinical outcomes, while adjusting for potential confounders such as age, sex, comorbidities, and vaccination status. o- Follow-Up: Patients will be followed up by phone at 1 and 3 months post-discharge to evaluate long-term outcomes, including survival, functional recovery, and quality of life. This follow-up is crucial for understanding the long-term burden of pneumococcal CAP and the potential impact of vaccination. o- Study Timeline and Sample Size: The study is expected to run for 2 years. The study will include all eligible patients hospitalized during this time, and the number of qualifying cases observed will determine the sample size. o- Ethical Considerations and Confidentiality: The study will be conducted in accordance with ethical guidelines for human research and will obtain approval from institutional review boards (IRBs) at all participating hospitals. Informed consent will be obtained from all patients (or their legal representatives) before enrollment. All patient data will be kept confidential, and participants will be identified only by a study-specific ID. o- Study Significance and Expected Impact: This study is the first of its kind in Colombia to comprehensively evaluate the incidence, prevalence, and clinical outcomes of pneumococcal CAP in adults. The findings will provide crucial data on the pneumococcal serotypes circulating in the region, informing vaccine policy and the potential introduction of new pneumococcal vaccines, such as PCV15, into the Colombian adult population. The study also aims to address the significant knowledge gap in the epidemiology of pneumococcal infections in LMICs, where data on adult pneumococcal CAP is limited.
Keywords
Pneumo-CAP, Community Acquired Pneumonia, CAP, Pneumococcal Pneumonia, Colombia
Medical subject headings
Community-Acquired Pneumonia, Pneumonia, Pneumococcal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  1. Severity of Pneumococcal CAP

    This outcome describes the clinical severity of pneumococcal community-acquired pneumonia among hospitalized adults, based on routinely used severity assessment tools.

    How it will be measured

    Severity will be determined using any of the three validated clinical scales routinely used by the treating clinician, and patients will be classified as having severe or non-severe disease according to the score applied:

    Pneumonia Severity Index (PSI) Range: Class I to Class V (0 to >130 points). Higher scores indicate worse severity and higher mortality risk. CURB-65 Score (Confusion, Urea, Respiratory rate, Blood pressure, Age ≥65) Range: 0 to 5 points. Higher scores indicate greater severity and higher mortality risk. Severe Community-Acquired Pneumonia Criteria (American Thoracic Society/Infectious Diseases Society of America) Definition: Severe CAP is identified by 1 major criterion or ≥3 minor criteria. Meeting criteria indicates higher severity and need for intensive care.

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

  2. Mortality

    In-hospital mortality and 3-month post-discharge mortality

    Measured: from recruitment until 3 months post-discharge

  3. ICU Admission

    This outcome captures whether adults hospitalized with CAP require admission to an intensive care unit at any point during their hospitalization, reflecting higher disease severity and need for advanced organ support.

    How it will be measured ICU admission will be determined through routine hospital records, documenting whether the patient was admitted to an ICU (medical, surgical, or mixed) during the index hospitalization. This includes admissions occurring directly from the emergency department or later during the hospital stay, up to discharge.

    Measured: Recorded on day of ICU admission (during index hospitalization)

  4. Variation in Quality of Life

    This outcome evaluates changes in quality of life among adults hospitalized with CAP, using the standardized EQ-5D-5L instrument, which measures health status across five domains.

    How it will be measured Quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) scale, which includes five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each scored from Level 1 (no problems) to Level 5 (extreme problems).

    The EQ-5D-5L also includes a visual analogue scale (EQ-VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health).

    Higher scores on the descriptive system indicate worse health, while higher VAS values indicate better perceived health.

    Variation will be assessed by comparing scores at different time points, based on when the tool is administered.

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

  5. Dyspnea persistence

    This outcome evaluates whether adults hospitalized with CAP continue to experience shortness of breath after the acute illness, using a standardized measure of breathlessness severity.

    How it will be measured Dyspnea will be assessed using the modified Medical Research Council (mMRC) Dyspnea Scale, which ranges from Grade 0 to Grade 4.

    Grade 0: Breathlessness only with strenuous exercise Grade 1: Shortness of breath when hurrying or walking up a slight hill Grade 2: Walks slower than peers or must stop when walking at own pace Grade 3: Stops for breath after walking ~100 meters Grade 4: Too breathless to leave the house or breathless when dressing Higher mMRC grades indicate worse dyspnea. Persistence will be determined by comparing dyspnea scores across relevant follow-up time points.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start28 Jun 2022
  3. Primary completion25 Feb 2025
  4. Study completion25 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
688 participants (actual)
Target duration
4 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07354425
Sponsor's protocol ID
MED-357-2023
Acronym
PneumoCAP
Status last verified
Jan 2026
First submitted
27 Nov 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The decision regarding the sharing of individual participant data has not yet been finalized. IPD availability will depend on ethical approvals, institutional policies, and data-governance requirements across participating sites.

Publications

  • Kung HC, Hoyert DL, Xu J, Murphy SL. Deaths: final data for 2005. Natl Vital Stat Rep. 2008 Apr 24;56(10):1-120.

    PubMed 18512336

  • Agency for Healthcare Research and Quality. Pneumonia is the Most Common Reason for Hospitalization. http://www.ahrq.gov/research/sep08/0908RA40.htm Accessed: 31 May 2011.

  • Self WH, Grijalva CG, Zhu Y, McNaughton CD, Barrett TW, Collins SP, Storrow AB, Griffin MR. Rates of emergency department visits due to pneumonia in the United States, July 2006-June 2009. Acad Emerg Med. 2013 Sep;20(9):957-60. doi: 10.1111/acem.12203. Epub 2013 Aug 27.

    PubMed 24033659

  • Grijalva CG, Nuorti JP, Arbogast PG, Martin SW, Edwards KM, Griffin MR. Decline in pneumonia admissions after routine childhood immunisation with pneumococcal conjugate vaccine in the USA: a time-series analysis. Lancet. 2007 Apr 7;369(9568):1179-86. doi: 10.1016/S0140-6736(07)60564-9.

    PubMed 17416262

  • Leal AL, Camacho G, Montañez A, Varon F, Alvarez C, Valderrama S, et al. 1628. Clinical, Epidemiological and Microbiological Characterization of Invasive Streptococcus pneumoniae Disease in Hospitalized Adults from 5 Tertiary Hospitals in Bogotá, Colombia: A Descriptive Study, Open Forum Infectious Diseases, Volume 6, Issue Supplement_2, October 2019, Pages S593-S594.

  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

    PubMed 3558716

  • Severiche-Bueno DF, Severiche-Bueno DF, Bastidas A, Caceres EL, Silva E, Lozada J, Gomez S, Vargas H, Viasus D, Reyes LF. Burden of invasive pneumococcal disease (IPD) over a 10-year period in Bogota, Colombia. Int J Infect Dis. 2021 Apr;105:32-39. doi: 10.1016/j.ijid.2021.02.031. Epub 2021 Feb 11.

    PubMed 33582374

  • Jain S, Williams DJ, Arnold SR, Ampofo K, Bramley AM, Reed C, Stockmann C, Anderson EJ, Grijalva CG, Self WH, Zhu Y, Patel A, Hymas W, Chappell JD, Kaufman RA, Kan JH, Dansie D, Lenny N, Hillyard DR, Haynes LM, Levine M, Lindstrom S, Winchell JM, Katz JM, Erdman D, Schneider E, Hicks LA, Wunderink RG, Edwards KM, Pavia AT, McCullers JA, Finelli L; CDC EPIC Study Team. Community-acquired pneumonia requiring hospitalization among U.S. children. N Engl J Med. 2015 Feb 26;372(9):835-45. doi: 10.1056/NEJMoa1405870.

    PubMed 25714161

  • Moore MR, Link-Gelles R, Schaffner W, Lynfield R, Lexau C, Bennett NM, Petit S, Zansky SM, Harrison LH, Reingold A, Miller L, Scherzinger K, Thomas A, Farley MM, Zell ER, Taylor TH Jr, Pondo T, Rodgers L, McGee L, Beall B, Jorgensen JH, Whitney CG. Effect of use of 13-valent pneumococcal conjugate vaccine in children on invasive pneumococcal disease in children and adults in the USA: analysis of multisite, population-based surveillance. Lancet Infect Dis. 2015 Mar;15(3):301-9. doi: 10.1016/S1473-3099(14)71081-3. Epub 2015 Feb 3.

    PubMed 25656600

  • Griffin MR, Zhu Y, Moore MR, Whitney CG, Grijalva CG. U.S. hospitalizations for pneumonia after a decade of pneumococcal vaccination. N Engl J Med. 2013 Jul 11;369(2):155-63. doi: 10.1056/NEJMoa1209165.

    PubMed 23841730

  • Jain S, Self WH, Wunderink RG, Fakhran S, Balk R, Bramley AM, Reed C, Grijalva CG, Anderson EJ, Courtney DM, Chappell JD, Qi C, Hart EM, Carroll F, Trabue C, Donnelly HK, Williams DJ, Zhu Y, Arnold SR, Ampofo K, Waterer GW, Levine M, Lindstrom S, Winchell JM, Katz JM, Erdman D, Schneider E, Hicks LA, McCullers JA, Pavia AT, Edwards KM, Finelli L; CDC EPIC Study Team. Community-Acquired Pneumonia Requiring Hospitalization among U.S. Adults. N Engl J Med. 2015 Jul 30;373(5):415-27. doi: 10.1056/NEJMoa1500245. Epub 2015 Jul 14.

    PubMed 26172429

  • Said MA, Johnson HL, Nonyane BA, Deloria-Knoll M, O'Brien KL; AGEDD Adult Pneumococcal Burden Study Team; Andreo F, Beovic B, Blanco S, Boersma WG, Boulware DR, Butler JC, Carratala J, Chang FY, Charles PG, Diaz AA, Dominguez J, Ehara N, Endeman H, Falco V, Falguera M, Fukushima K, Garcia-Vidal C, Genne D, Guchev IA, Gutierrez F, Hernes SS, Hoepelman AI, Hohenthal U, Johansson N, Kolek V, Kozlov RS, Lauderdale TL, Marekovic I, Masia M, Matta MA, Miro O, Murdoch DR, Nuermberger E, Paolini R, Perello R, Snijders D, Plecko V, Sorde R, Stralin K, van der Eerden MM, Vila-Corcoles A, Watt JP. Estimating the burden of pneumococcal pneumonia among adults: a systematic review and meta-analysis of diagnostic techniques. PLoS One. 2013;8(4):e60273. doi: 10.1371/journal.pone.0060273. Epub 2013 Apr 2.

    PubMed 23565216

  • Wunderink RG, Self WH, Anderson EJ, Balk R, Fakhran S, Courtney DM, Qi C, Williams DJ, Zhu Y, Whitney CG, Moore MR, Bramley A, Jain S, Edwards KM, Grijalva CG. Pneumococcal Community-Acquired Pneumonia Detected by Serotype-Specific Urinary Antigen Detection Assays. Clin Infect Dis. 2018 May 2;66(10):1504-1510. doi: 10.1093/cid/cix1066.

    PubMed 29342250

  • LeBlanc JJ, ElSherif M, Ye L, MacKinnon-Cameron D, Li L, Ambrose A, Hatchette TF, Lang AL, Gillis H, Martin I, Andrew MK, Boivin G, Bowie W, Green K, Johnstone J, Loeb M, McCarthy A, McGeer A, Moraca S, Semret M, Stiver G, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN). Burden of vaccine-preventable pneumococcal disease in hospitalized adults: A Canadian Immunization Research Network (CIRN) Serious Outcomes Surveillance (SOS) network study. Vaccine. 2017 Jun 22;35(29):3647-3654. doi: 10.1016/j.vaccine.2017.05.049. Epub 2017 May 26.

    PubMed 28554501

  • Pilishvili T, Lexau C, Farley MM, Hadler J, Harrison LH, Bennett NM, Reingold A, Thomas A, Schaffner W, Craig AS, Smith PJ, Beall BW, Whitney CG, Moore MR; Active Bacterial Core Surveillance/Emerging Infections Program Network. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis. 2010 Jan 1;201(1):32-41. doi: 10.1086/648593.

    PubMed 19947881

Questions about this trial

What is this clinical trial studying?

An observational study of Community Acquired Pneumonia (CAP) and Pneumococcal Pneumonia, run by Universidad de la Sabana at 11 sites in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Pneumococcal Community-Acquired Pneumonia (CAP) (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07354425, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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