Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:55 AM
Ignite Modification Date:
2025-12-24 @ 11:55 AM
NCT ID:
NCT00717561
Eligibility Criteria:
Inclusion Criteria:
* Hospitalized non-ICU patients (age, \>= 18 years)
* Clinical signs and symptoms of CAP, with PSI score IV or V
* Radiologically confirmed evidence of a new and/or progressive infiltrate(s)
* Requirement for initial parenteral therapy
* At least 2 of the following conditions:
* Productive or non productive cough with or without purulent or mucosus or mucopurulent sputum
* Dyspnea and/or tachypnea (respiratory rate of \> 20 breaths/min)
* Rigors and/or chills
* Pleuritic chest pain
* Auscultatory findings of rales and/or crackles on pulmonary examination and/or evidence of pulmonary consolidation
* Fever (an oral temperature of \>= 38 °C, a rectal temperature of \>= 39 °C, or a tympanic temperature of \>= 38.5 °C) or hypothermia (rectal or core temperature of \< 35 °C), and a WBC count of \>= 10,000 cells/mm3 or \>= 15% immature neutrophils bands; regardless of peripheral WBC count) or leukopenia (total WBC count of \< 4500 cells/mm3)
* Written informed consent
Exclusion Criteria:
* PSI Class I-III and V with need for ICU admission
* Hospitalization for \> 48 hours before developing pneumonia, or discharge from hospital \< 30 days prior. Note: patients currently residing in residential long-term facilities can be enrolled in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00717561
Study Brief:
Protocol Section:
NCT00717561