Azithromycin versus doxycycline as atypical coverage for adults hospitalized with community-acquired pneumonia on a beta-lactam
Official title: Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
Run by Mayo Clinic · NCT07164131 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1120 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 5 sites (Scottsdale, Arizona and 4 other locations) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | September 1, 2030 |
| Study ends | September 1, 2031 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT07164131 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 (\> 450 ms in men and \> 460 ms in women) * Incarcerated individuals (prisoner)
Where it's running
-
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting -
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 Health System-La Crosse
La Crosse, Wisconsin, United States Not yet recruiting
Study contacts
- Principal investigator: Ognjen Gajic, MD MS — Mayo Clinic
- Study coordinator: Amy Amsbaugh, RRT
- Email: amsbaugh.amy@mayo.edu
- Phone: 5075387538
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.