Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID07164131

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

Led by Mayo Clinic · Updated on 2025-10-08

1120

Participants Needed

5

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing the effectiveness and safety of two antibiotics, Azithromycin and Doxycycline, in adult patients hospitalized with community-acquired pneumonia (CAP) who are also treated with Beta-lactam antibiotics. This study focuses on adults admitted with CAP and aims to provide important information on which antibiotic may be more suitable when combined with standard Beta-lactam therapy. Participants will be randomly assigned to receive either Azithromycin or Doxycycline alongside Beta-lactam treatment. Both antibiotics may be given orally or intravenously within 12 hours of hospital admission, with treatment lasting between 5 to 7 days. The study includes two groups: one receiving Doxycycline and the other Azithromycin, both as part of standard care. During the study, researchers will track hospital-free days over 28 days as the main outcome. They will also monitor oxygen-free days, mortality up to 180 days, and the need for advanced respiratory support or in-hospital death within 28 days. Participants will be closely observed throughout their hospital stay and follow-up periods to assess these outcomes and ensure safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients over 18 years old
  • Hospitalized with community-acquired pneumonia
  • Receiving beta-lactam antibiotic plus azithromycin or doxycycline within 12 hours of admission
  • Receiving treatment started in the emergency department
  • Able to receive study treatment within 12 hours of hospital admission
Not Eligible

You will not qualify if you...

  • High suspicion of Legionella pneumonia
  • Allergy or contraindication to azithromycin or doxycycline
  • Antibiotics prescribed for conditions other than community-acquired pneumonia
  • Pregnant women
  • Severe community-acquired pneumonia as defined by ATS/IDSA criteria
  • Corrected QT prolongation (>440 ms in men, >460 ms in women)
  • Receiving antibiotics other than azithromycin or doxycycline (e.g., quinolones)
  • Hospital admission longer than 24 hours before enrollment
  • Known prisoner status

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 5 to 7 days

Participants receive either Doxycycline or Azithromycin in combination with beta-lactam therapy starting within 12 hours of hospital admission for community-acquired pneumonia.

1 to 2 visits during hospitalization

Trial Site Locations

Total: 5 locations

1

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

Not Yet Recruiting

2

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224

Not Yet Recruiting

3

Mayo Clinic Health System-Mankato

Mankato, Minnesota, United States, 56001

Not Yet Recruiting

4

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

5

Mayo Clinic Health System-La Crosse

La Crosse, Wisconsin, United States, 54601

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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