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NCT Number: NCT07164131

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Hospital-free days

    Time frame: 28 days

    Number of days subject remained out of hospital

Secondary outcomes

  1. Oxygen-free days

    Time frame: 28 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

    Time frame: 180 days

    Defined as mortality at 180 days after discharge

  3. Need for advanced respiratory support or in-hospital mortality

    Time frame: Up to 28 days

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Acronym: AD-CAP

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Sep 9, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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