Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

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

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1120 (estimated)
SponsorMayo Clinic
Academic / other
Locations5 sites (Scottsdale, Arizona and 4 other locations)
StatusRecruiting
StartedSeptember 15, 2025
Main results expectedSeptember 1, 2030
Study endsSeptember 1, 2031
Registry record updatedSeptember 24, 2026
Trial IDNCT07164131 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.