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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2031-09-01

Brief Summary

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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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Detailed Description

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Conditions

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Community-acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Doxycycline group

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

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type 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 group

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

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No