2. Methods
We analysed data from a prospective observational study aimed to evaluate the incidence of major vascular events in hospitalized adult patients with pneumonia (clinical.trial.gov: NCT01773863).
This cohort study prospectively recruited and followed up patients referred to 3 medical centres from the University-Hospital Policlinico Umberto I, Sapienza University of Rome, Italy: Department of Internal Medicine and Medical Specialties, Department of Clinical Medicine, Department of Public Health and Infectious Diseases).
We enrolled adults who met the following criteria: 1) age ≥18 years; 2) clinical presentation of an acute illness with at least two or more of the signs or symptoms of CAP, as previously reported 4 and 3) presence of new consolidation(s) on chest X-ray.12 Pneumonia was defined as CAP diagnosed upon hospitalization in a patient who did not meet the criteria for healthcare-associated pneumonia.13
Exclusion criteria were: immunosuppression (HIV infection, chemotherapy, high dose of immunosuppressive agents to prevent the rejection of transplanted organs and tissues or to treat autoimmune diseases); critical illness requiring admission to an intensive care unit,14 presence of malignancy; pregnancy or breastfeeding; documented severe allergy to antibiotics; healthcare-associated pneumonia.13
All patients with CAP admitted to the 3 units after giving written informed consent from October 2011 to January 2016, were prospectively recruited and followed up. The present study was conducted according to the principles stated in the Declaration of Helsinki. The study was approved by the local Ethics Committee Prot. n. 864/11.