Pneumococcal Community-Acquired Pneumonia Requiring Hospitalization Among Colombian Adults
Colombia688 participantsStarted 2022-06-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Pneumococcal Community-Acquired Pneumonia (CAP)
Timeframe: 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
Timeframe: 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
Timeframe: 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)