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Led by Mayo Clinic · Updated on 2026-07-02
1120
Participants Needed
5
Research Sites
52 weeks
Total Duration
Researchers are comparing the effectiveness and safety of two antibiotics, Azithromycin and Doxycycline, in adults hospitalized with community-acquired pneumonia CAP who are also treated with beta-lactam antibiotics. This research focuses on evaluating these treatments in a hospital setting to better understand their impact on patient outcomes. Participants will be randomly assigned to receive either Azithromycin or Doxycycline, given orally or intravenously, alongside beta-lactam therapy within 12 hours of hospital admission. The treatment duration for both drugs is planned for 5 to 7 days. Subjects will receive standard care treatment during their hospital stay. During the study, participants will be monitored for hospital-free days within 28 days, oxygen-free days in the same period, need for advanced respiratory support or in-hospital mortality up to 28 days, and mortality up to 180 days. The study involves regular assessments to track these outcomes, aiming to provide insights into treatment impact and patient recovery over time.
CONDITIONS
Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
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Mayo Clinic
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Azithromycin (with beta-lactam) | Doxycycline (with beta-lactam) |
|---|---|---|
| What it is | Azithromycin, a macrolide antibiotic, is given orally or through an IV, in combination with a beta-lactam antibiotic for 5–7 days. Therapy starts within 12 hours of hospital admission. | Doxycycline, a tetracycline antibiotic, is given orally or through an IV, in combination with a beta-lactam antibiotic for 5–7 days. Therapy starts within 12 hours of hospital admission. |
| Role in the trial | Active intervention arm comparing azithromycin as atypical coverage in addition to beta-lactam treatment. | Active comparator arm testing doxycycline as atypical coverage alongside beta-lactam treatment. |
| Primary use | Combined with a beta-lactam, azithromycin provides broad-spectrum and atypical pathogen coverage for adults admitted with community-acquired pneumonia. | Combined with a beta-lactam, doxycycline is used for broad-spectrum and atypical bacterial coverage in hospitalized adults with CAP. |
| How it is given or performed | Azithromycin is started within 12 hours of admission, given by mouth or IV for 5 to 7 days, alongside a beta-lactam antibiotic. | Doxycycline is started within 12 hours of admission, given by mouth or IV for 5 to 7 days, alongside a beta-lactam antibiotic. |
| Evidence status | Evidence from pragmatic clinical trials and published guidelines supports azithromycin in combination for CAP, but direct randomized data comparing against doxycycline in combination are limited. This trial is designed to provide direct evidence. | Doxycycline is guideline-accepted for atypical CAP coverage but direct head-to-head evidence with azithromycin plus beta-lactam is scarce. This study tests comparative effectiveness in real-world hospital practice. |
| Important limitations | The potential risk for cardiac arrhythmias is higher with azithromycin, especially for patients with baseline QT prolongation. Both arms exclude severe CAP and specific comorbidities. | Doxycycline can be limited by contraindications and potential allergies. Results apply only to the non-severe CAP population included in the trial. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 7 days
Participants receive either Azithromycin or Doxycycline alongside beta-lactam therapy within 12 hours of hospital admission. Treatment lasts 5 to 7 days while hospitalized.
During hospital stay
Duration - Up to 180 days
Participants are monitored for hospital-free days, oxygen-free days, need for advanced respiratory support or in-hospital mortality up to 28 days, and mortality up to 180 days after treatment.
Regular assessments during follow-up period
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Aysun Tekin, Amos Lal, Autumn Brogan...
https://pubmed.ncbi.nlm.nih.gov/42509011/Mayo Clinic
Lead Sponsor
