Recruiting NCT07164131
Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Doxycycline, Azithromycin.
- Who it may be relevant to
- Registry conditions: Community-acquired Pneumonia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug 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. - 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.
Primary outcome measures
- Hospital-free days [Time frame: 28 days]
Secondary outcome measures (3)
- Oxygen-free days [Time frame: 28 days]
- 180-day mortality [Time frame: 180 days]
- Need for advanced respiratory support or in-hospital mortality [Time frame: Up to 28 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Mayo Clinic in Arizona — Scottsdale
- Mayo Clinic in Florida — Jacksonville
- Mayo Clinic Health System-Mankato — Mankato
- Mayo Clinic in Rochester — Rochester
- Mayo Clinic Health System-La Crosse — La Crosse
Publications
- Tekin A, Lal A, Brogan A, Bellolio F, O'Horo JC, Yadav H, Schulte P, Gajic O, Barreto EF, Odeyemi YE; Acute Care Clinical Trial Platform Investigators. Azithromycin versus doxycycline in hospitalised adult patients with community-acquired pneumonia treated with beta-lactams: protocol for a pragmatic randomised clinical trial. BMJ Open. 2026 Jul 27;16(7):e118028. doi: 10.1136/bmjopen-2026-118028. PMID 42509011
Identifiers
NCT: NCT07164131 · 24-006503