Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified August 2025 by Mayo Clinic
Sponsor
Mayo Clinic
Information Provided by (Responsible Party)
Yewande Odeyemi, MD
Clinicaltrials.gov Identifier
NCT07164131
Other Study ID Numbers:
24-006503
First Submitted
August 19, 2025
First Posted
September 8, 2025
Last Update Posted
October 7, 2025
Last Verified
August 2025

ClinicalTrials.gov processed this data on October 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Community-acquired Pneumonia
Drug: DoxycyclineDrug: Azithromycin

Study Design

Study TypeInterventional
Actual Enrollment1120 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAzithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
Study Start DateSeptember 14, 2025
Actual Primary Completion Date4yrs 3mos from now
Actual Study Completion Date5yrs 3mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Doxycycline group
Subjects hospitalized for community acquired pneumonia will receive standard of care treatment with Doxycycline
Drug: 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 group
Subjects hospitalized for community acquired pneumonia will receive standard of care treatment with Azithromycin
Drug: 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.

Outcome Measures

Primary Outcome Measures
  1. Hospital-free days
    Number of days subject remained out of hospital
Secondary Outcome Measures
  1. 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
  2. 180-day mortality
    Defined as mortality at 180 days after discharge
  3. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsMayo Clinic
Locations
Mayo Clinic in Arizona | Scottsdale Arizona, United States, 85259Mayo Clinic in Florida | Jacksonville Florida, United States, 32224Mayo Clinic Health System-Mankato | Mankato Minnesota, United States, 56001Mayo Clinic in Rochester | Rochester Minnesota, United States, 55905Mayo Clinic Health System-La Crosse | La Crosse Wisconsin, United States, 54601
Investigators
Principal Investigator: Yewande Odeyemi, Mayo Clinic