Azithromycin versus doxycycline as atypical coverage for adults hospitalized with community-acquired pneumonia on a beta-lactam
Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
This trial will test whether adding azithromycin or doxycycline to a beta-lactam works better and is safer for adults hospitalized with community-acquired pneumonia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 5 sites (Scottsdale, Arizona and 4 other locations) |
| Trial ID | NCT07164131 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional trial compares two commonly used antibiotics (azithromycin and doxycycline) given alongside a beta-lactam in adults hospitalized with community-acquired pneumonia. Eligible patients are adults admitted with CAP who receive a beta-lactam plus either azithromycin or doxycycline within 12 hours of admission. Key exclusions include high suspicion for Legionella, severe CAP, QT prolongation, pregnancy, receipt of other antibiotics like quinolones, admission >24 hours, and prisoners. The trial will measure clinical effectiveness and safety outcomes during the hospital course at Mayo Clinic sites.
Who should consider this trial
Good fit: Adults over 18 hospitalized with community-acquired pneumonia who receive a beta-lactam plus either azithromycin or doxycycline in the emergency department within 12 hours of admission are ideal candidates.
Not a fit: Patients with suspected Legionella, severe CAP, significant QT prolongation, pregnancy, those receiving other non-study antibiotics, or prisoners are excluded and would not receive benefit from participation.
Why it matters
Potential benefit: If successful, the results could help clinicians choose the safer and more effective atypical antibiotic to add to beta-lactams for hospitalized CAP patients, potentially improving outcomes and reducing side effects.
How similar studies have performed: Previous trials and observational studies have supported adding a macrolide to a beta-lactam in hospitalized CAP, but direct head-to-head randomized data comparing macrolides with doxycycline are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Scottsdale, Arizona and 4 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Not_yet_recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Not_yet_recruiting)
- Mayo Clinic Health System-Mankato — Mankato, Minnesota, United States (Not_yet_recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
- Mayo Clinic Health System-La Crosse — La Crosse, Wisconsin, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Yewande Odeyemi — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.