Community-acquired pneumonia (CAP), Streptococcus pneumoniae bacteria
Conditions
Interventions
Not applicable.
Sponsors
Merck Sharp & Dohme (MSD)
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, =65 years of age, at the time of signing informed consent 2. The patient (or legally acceptable representative (LAR)) has provided documented informed consent for the study 3. Assessed in hospital or referred to hospital from urgent care setting with clinical suspicion of CAP (Note: Patients referred from assisted living care/centers will be eligible) 4. Has =2 of the following clinical signs or symptoms: • fever (oral temperature >38.0°C/100.4°F or tympanic temperature >38.5°C/101.2°F), • hypothermia (<35.5°C/95.9°F measured by a healthcare provider), • chills or rigors, • pleuritic chest pain, • new or worsening cough, • sputum production, • dyspnea (shortness of breath), • tachypnea (respiratory rate >20/min), • malaise, or • abnormal auscultatory findings suggestive of pneumonia (rales or evidence of pulmonary consolidation including dullness on percussion, bronchial breath sounds, or egophony) 5. Availability of imaging studies to support the CAP diagnosis.
Exclusion criteria
Exclusion criteria: 1. Transfer from other hospitals, skilled nursing care, or acute rehabilitation 2. Aspiration pneumonia, hospital-acquired bacterial pneumonia (if a patient develops signs or symptoms 48 hours after being hospitalized), or ventilator-associated bacterial pneumonia 3. Patients hospitalized for pneumonia or respiratory infection within the last 30 days 4. Patients with known bronchial obstruction or a history of post-obstructive pneumonia (note: this criterion does not exclude patients who have chronic obstructive pulmonary disease [COPD]) 5. Patients with primary or metastatic lung cancer 6. Patients with cystic fibrosis, known or suspected Pneumocystis jiroveci pneumonia, or known or suspected active tuberculosis 7. Patients who do not/ are not able to provide a urine sample (e.g., anuric) and a blood sample as standard of care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study has no exposure or health outcomes. Variables collected in the pilot are intended to evaluate planned study operations and procedures, to refine study methods, including choice and definition of covariates, sample size and analysis plan, and to determine the best source(s) from which to collect required study data elements. The data collection tool will be designed such that sites must confirm variables are missing or unknown in order to critically assess potential data availability for the full TND study. Patient-level data will be captured in electronic case report forms (eCRFs). Additionally, summary-level data including number of CAP patients potentially meeting eligibility criteria and the proportion of patients who have received previous pneumococcal vaccines aggregated into standardized data collection tables will be requested from the site or healthcare system. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Canada, Germany, Italy, Netherlands, Spain, United States
Contacts
Public ContactS.F. Arroyo
European Clinical Research Alliance on Infectious Diseases (Ecraid)
Outcome results
None listed