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

NCT07164131 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 24-006503
• Study Type: interventional
• Target: 1,120
• Locations: 1 country
• Sites: 5

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

Keywords

Azithromycin; Doxycycline; hospitalized

Outcome Measures

Primary Outcomes (1)

• Hospital-free days

  Number of days subject remained out of hospital

  28 days

Secondary Outcomes (3)

• Oxygen-free days

  28 days

• 180-day mortality

  180 days

• Need for advanced respiratory support or in-hospital mortality

  Up to 28 days

Study Arms (2)

Doxycycline group

ACTIVE COMPARATOR

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

Drug: Doxycycline

Azithromycin group

ACTIVE COMPARATOR

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

Drug: Azithromycin

Interventions

Doxycycline DRUG

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.

Doxycycline group

Azithromycin DRUG

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.

Azithromycin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (5)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

NOT YET RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

Mayo Clinic Health System-Mankato

Mankato, Minnesota, 56001, United States

NOT YET RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Mayo Clinic Health System-La Crosse

La Crosse, Wisconsin, 54601, United States

NOT YET RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Doxycycline; Azithromycin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Yewande Odeyemi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 9, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)