Community-acquired Pneumonia
Conditions
Keywords
Azithromycin, Doxycycline, hospitalized
Brief summary
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.
Interventions
DRUGDoxycycline
Subjects will receive Doxycycline (orally or intravenously) in combination with beta-lactam therapy within 12 hours of hospital admission. Treatment duration will be 5-7 days.
DRUGAzithromycin
Subjects will receive Azithromycin (orally or intravenously) in combination with beta-lactam therapy within 12 hours of hospital admission. Treatment duration will be 5-7 days.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• All adult patients (\>18 years old) admitted with CAP and receiving a beta-lactam antibiotic plus a form of atypical coverage (azithromycin or doxycycline) in the ED within 12 hours of admission.
Exclusion criteria
* 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) * Severe CAP as defined by the ATS/IDSA criteria * Corrected QT prolongation (\> 440 ms in men and \> 460 ms in women) * Receiving a different antibiotic (e.g quinolones) * Admission \> 24 hours * Known to be a prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital-free days | 28 days | Number of days subject remained out of hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen-free days | 28 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 |
| 180-day mortality | 180 days | Defined as mortality at 180 days after discharge |
| Need for advanced respiratory support or in-hospital mortality | Up to 28 days | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYewande Odeyemi
Mayo Clinic
Outcome results
None listed