Pneumococcal Community-Acquired Pneumonia Requiring Hospitalization Among Colombian Adults (Pneumo-CAP Colombia)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 688
研究概览
简要总结
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.
详细描述
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:
- 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.
- To determine the prevalence of pneumococcal CAP among patients requiring hospitalization for CAP in the Sabana Centro region of Colombia.
- 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.
- To estimate the incidence of pneumococcal CAP that requires hospitalization and the contribution of PCV15 serotypes to the disease burden in the region.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •(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.
研究者
Luis Felipe Reyes
MD, PhD, MSc Principal Investigator
Universidad de la Sabana