Azithromycin vs Doxycycline for Community-acquired Pneumonia

(AD-CAP Trial)

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must be taking: Beta-lactams

Must not be taking: Quinolones

Disqualifiers: Legionella, Pregnancy, Severe CAP, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

1120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two antibiotics, Azithromycin and Doxycycline, to determine which is more effective and safer for treating community-acquired pneumonia in adults. Participants will receive one of these antibiotics along with a beta-lactam, a common type of antibiotic. Candidates include those hospitalized with pneumonia who began treatment with these medications within 12 hours of admission. The trial aims to identify which treatment aids patient recovery more effectively. As a Phase 4 trial, this research focuses on understanding how these FDA-approved treatments can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications, but you cannot participate if you are already taking a different antibiotic for pneumonia.

What is the safety track record for these treatments?

Studies have shown that both Azithromycin and Doxycycline are generally safe for treating pneumonia. Azithromycin has been linked to better outcomes in hospitalized patients with community-acquired pneumonia (CAP), including lower death rates. One study found that patients taking Azithromycin spent fewer days in the hospital compared to those on other treatments.

Doxycycline is also safe and well-tolerated for treating pneumonia. Research shows no major differences in safety when comparing Doxycycline to other recommended treatments for CAP.

Both antibiotics have been widely used and studied, proving they are generally safe, with side effects being rare or mild. Prospective trial participants might find this information reassuring regarding the safety of both treatments. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because Azithromycin and Doxycycline offer distinct benefits for community-acquired pneumonia. Azithromycin is known for its anti-inflammatory properties, which can help reduce symptoms faster and improve lung function. On the other hand, Doxycycline is valued for its broad-spectrum activity against various bacteria, including atypical pathogens that are sometimes missed by other antibiotics. These unique features make them promising options compared to standard treatments, potentially offering faster recovery and broader bacterial coverage.

What evidence suggests that this trial's treatments could be effective for community-acquired pneumonia?

This trial will compare Azithromycin and Doxycycline for treating community-acquired pneumonia (CAP). Research has shown that Azithromycin, which participants in this trial may receive, is linked to lower death rates and better recovery in patients with CAP. Studies indicate that patients treated with Azithromycin spent fewer days in the hospital compared to those receiving other treatments. Meanwhile, Doxycycline, another treatment option in this trial, effectively treats mild to moderate CAP and works as well as other antibiotics like macrolides and fluoroquinolones in these cases. Both antibiotics are good options, but Azithromycin might provide better results in more severe cases. ^{2 3 5 6 7}

Who Is on the Research Team?

Yewande Odeyemi

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adults over 18 hospitalized with community-acquired pneumonia (CAP) who are already taking a beta-lactam antibiotic can join. Excluded are pregnant women, those with certain heart rhythm issues (QT prolongation), late admissions, prisoners, suspected Legionella infection cases, allergies to the study drugs, severe CAP by ATS/IDSA criteria or on different antibiotics.

Inclusion Criteria

I am over 18, have pneumonia, and got specific antibiotics within 12 hours of hospital admission.

Exclusion Criteria

Pregnant women (based on clinical assessment as part of standard of care)

Corrected QT prolongation (> 440 ms in men and > 460 ms in women)

Admission > 24 hours

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care treatment with either Azithromycin or Doxycycline for community acquired pneumonia

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hospital-free days and oxygen-free days

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Azithromycin
• Doxycycline

Trial Overview The trial is testing the effectiveness and safety of Azithromycin versus Doxycycline in treating CAP when used alongside a beta-lactam antibiotic. It aims to determine which combination works better for adults admitted to the hospital.

How Is the Trial Designed?

Group I: Doxycycline group Active Control 1 Intervention

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

Group II: Azithromycin group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40378193/

Comparative effectiveness of azithromycin versus ... Among hospitalized patients with community-acquired pneumonia, azithromycin was associated with a lower mortality and more hospital free ...

2. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf252/8133936?searchresult=1

A Multicenter Matched Cohort Study - Oxford Academic Among hospitalized patients with CAP, azithromycin was associated with lower mortality and more HFDs compared with doxycycline in combination ...

3. cidrap.umn.edu cidrap.umn.edu/antimicrobial-stewardship/better-outcomes-found-hospitalized-pneumonia-patients-treated

Better outcomes found in hospitalized pneumonia patients ... An observational study of hospitalized patients with community-acquired pneumonia (CAP) found that azithromycin was associated with lower mortality and more ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/8861376

Clinical Effectiveness and Outcomes of Azithromycin ... The primary endpoint was the percentage of patients who achieved clinical stability within 3 days, while secondary endpoints were the average ...

5. publications.ersnet.org publications.ersnet.org/content/erj/64/suppl68/pa5095

The comparison of outcomes in community-acquired ... Conclusion: Our results suggest a potential association between improved outcomes in CAP patients treated with AZM compared to DOX when combined with BL.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9802626/

Safety & Efficacy of Azithromycin for Childhood Pneumonia Conclusion: Azithromycin used once daily for 5 days produced a satisfactory therapeutic outcome similar to those of amoxicillin/clavulanate or erythromycin ...

7. journal.chestnet.org journal.chestnet.org/article/S0012-3692(21)01941-3/fulltext

Azithromycin for Community-Acquired Pneumonia: A Study 26 patients (26.0%) were prescribed azithromycin for longer than the maximum recommended duration of 5 days for non-legionella pneumonia. The average number of ...