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:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT03109106
Eligibility Criteria:
Inclusion Criteria:
* Candidate patients will have evidence of an acute lower respiratory tract infection (pneumonia or acute exacerbation of chronic bronchitis) as defined as follows:
o NEW onset within past 28 days
* At least one respiratory symptom: cough, sputum production, dyspnea, tachypnea, pleuritic chest pain, wheezing
PLUS: At least one :
* auscultation abnormality suggestive of pneumonia (rales, ronchi, egophony)
* OR a new consolidation on chest radiology consistent with pneumonia
* OR at least one sign of systemic infection: fever \>38.1 or WBC \>10,000 or \<4,000 AND provider initiating empiric antibiotics
Exclusion Criteria:
* \- Age \<18
* Microbiologically documented infections caused by organisms for which a prolonged duration is standard of care (i.e. Pseudomonas, Acinetobacter, Listeria, Legionella, Pneumocystis, M. tuberculosis, Non-tuberculous mycobacterium (NTM) infection, S. aureus pneumonia or cavitary pneumonia)
* Severe infections due to viruses and parasites with a risk of bacterial translocation (hemorrhagic fever, malaria)
* Infectious conditions requiring prolonged therapy: endocarditis, brain abscess, deep abscess
* Antibiotics already started 24 hours prior to initial PCT value
* Chronic localized infections (i.e. chronic osteomyelitis, mediastinitis, brain abscess)
* Severely immunocompromised patients (HIV with CD4\<200, neutropenic with absolute neutrophil count (ANC) \<500, patients on immunosuppressive therapy after solid organ transplantation or those with autoimmune disease (corticosteroids allowed but no more than 20 mg/day (prednisone equivalent) for 14 days). Cystic fibrosis
* Active IV drug abuse
* Pregnant patients
* Patients lacking capacity to consent
* Patients admitted for burn injuries
* Patients within 30 days of major intra-thoracic or intra-abdominal surgery
* Patients receiving antibiotics for a non-respiratory infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03109106
Study Brief:
Protocol Section:
NCT03109106