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Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia

Not Applicable
Not yet recruiting
Conditions
Community-acquired Pneumonia
Interventions
Registration Number
NCT07164131
Lead Sponsor
Mayo Clinic
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
1120
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Doxycycline groupDoxycyclineSubjects hospitalized for community acquired pneumonia will receive standard of care treatment with Doxycycline
Azithromycin groupAzithromycinSubjects hospitalized for community acquired pneumonia will receive standard of care treatment with Azithromycin
Primary Outcome Measures
NameTimeMethod
Hospital-free days28 days

Number of days subject remained out of hospital

Secondary Outcome Measures
NameTimeMethod
Oxygen-free days28 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

180-day mortality180 days

Defined as mortality at 180 days after discharge

Need for advanced respiratory support or in-hospital mortalityUp 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.

Trial Locations

Locations (5)

Mayo Clinic in Arizona

🇺🇸

Scottsdale, Arizona, United States

Mayo Clinic in Florida

🇺🇸

Jacksonville, Florida, United States

Mayo Clinic Health System-Mankato

🇺🇸

Mankato, Minnesota, United States

Mayo Clinic in Rochester

🇺🇸

Rochester, Minnesota, United States

Mayo Clinic Health System-La Crosse

🇺🇸

La Crosse, Wisconsin, United States

Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States

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