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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline group | Active Comparator | Subjects hospitalized for community acquired pneumonia will receive standard of care treatment with Doxycycline |
|
| Azithromycin group | Active Comparator | Subjects hospitalized for community acquired pneumonia will receive standard of care treatment with Azithromycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital-free days | Number of days subject remained out of hospital | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days |
| 180-day mortality |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Yewande Odeyemi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Not yet recruiting | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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De-identified individual participant data and the accompanying data dictionary will be made available in a secure, controlled-access data repository within one year of publication. Statistical code (R scripts) and supporting documentation will be shared via GitHub to enable transparency and reproducibility.
Within one year after publication of the primary results manuscript.
Qualified investigators may request access to the de-identified data under a data use agreement.
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| Azithromycin | Drug | 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. |
|
Defined as mortality at 180 days after discharge
| 180 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. | Up to 28 days |
| Mayo Clinic in Florida | Not yet recruiting | Jacksonville | Florida | 32224 | United States |
|
| Mayo Clinic Health System-Mankato | Not yet recruiting | Mankato | Minnesota | 56001 | United States |
|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Mayo Clinic Health System-La Crosse | Not yet recruiting | La Crosse | Wisconsin | 54601 | United States |
|
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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