Recruiting

Azithromycin vs. Doxycycline

Sponsor:

Mayo Clinic

Code:

NCT07164131

Conditions

Community-acquired Pneumonia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Doxycycline

Azithromycin

Study Details

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.

Conditions

Community-acquired Pneumonia

Study ID

NCT07164131

Start date

Sep 15, 2025

Status verified date

Jun, 2026

Completion date

Sep 1, 2031

Anticipated

Primary completion date

Sep 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Doxycycline group

Subjects hospitalized for community acquired pneumonia will receive standard of care treatment with Doxycycline

active comparator: Azithromycin group

Subjects hospitalized for community acquired pneumonia will receive standard of care treatment with Azithromycin

Interventions

Doxycycline

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.

Azithromycin

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.

Primary outcome measure

  • Hospital-free days [ Time Frame: 28 days ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amy Amsbaugh

507-538-7538amsbaugh.amy@mayo.edu

Principal Investigator:

Yewande Efunpeju Odeyemi

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Azithromycin
  • Doxycycline
  • hospitalized

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-02.