The purpose of this study is to compare effectiveness and safety of Azithromycin versus Doxycycline in adult patients hospitalized with community acquired pneumonia (CAP) treated with Beta-lactams.
None
High clinical suspicion for Legionella pneumonia
Allergy or contraindication to the use of either azithromycin or doxycycline (usual clinical practice)
Antibiotics not for CAP
Pregnant women (based on clinical assessment as part of standard of care)
Parallel
Doxycycline
DrugSubjects will receive Doxycycline (orally or intravenously) in combination with beta-lactam therapy within 12 hours of hospital admission. Treatment duration will be determined by treating clinician (5-7 days per guidelines).
Azithromycin
DrugSubjects will receive Azithromycin (orally or intravenously) in combination with beta-lactam therapy within 12 hours of hospital admission. Treatment duration will be determined by treating clinician (5-7 days per guidelines).
Days alive and out of hospital
Days alive spent outside of the hospital, within 28 days of randomization
Oxygen-free days
Number of days subject does not require new supplemental oxygen use. Oxygen-free days will be set as 0 for patients who died during the stay or had a length of stay of ≥28 days
Need for advanced respiratory support or in-hospital mortality
Defined as a composite of need for advanced respiratory support or mortality during hospitalization. Need for advanced respiratory support would include need for high flow nasal cannula, non-invasive positive pressure ventilation, and invasive ventilation in patients not requiring this at baseline.
Need for Advanced Respiratory Support
Need for advanced respiratory support including invasive mechanical ventilation, non-invasive mechanical ventilation, high flow nasal cannula,
In-Hospital Mortality
Mortality during hospitalization
Incident Clostridioides difficile infection
Positive stool antigen test, will only be assessed when testing is ordered as part of routine clinical care
New arrhythmias requiring intervention and/or QT prolongation
Outcome will only be assessed when an ECG is ordered as part of routine clinical care
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Mayo Clinic
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
