Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams (AD-CAP)

Mayo Clinic

Status and phase: Enrolling; Phase 4

Conditions: Community-acquired Pneumonia

Treatments: Drug: Doxycycline; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT07164131

24-006503

Details and patient eligibility

About

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.

Enrollment: 1,120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,120 participants in 2 patient groups

Doxycycline group

Active Comparator group

Description:

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

Treatment:

Drug: Doxycycline

Azithromycin group

Active Comparator group

Description:

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

Treatment:

Drug: Azithromycin