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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Doxycycline

    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

    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.

Treatment groups

1,120 Participants
are divided into 2 treatment groups
Group A: Doxycycline groupActive comparator 1 intervention
Group B: Azithromycin groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hospital-free days

Number of days subject remained out of hospital

Time frame
28 days

Secondary outcomes

1

Oxygen-free 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

Time frame
28 days
2

180-day mortality

Defined as mortality at 180 days after discharge

Time frame
180 days
3

Need for advanced respiratory support or in-hospital mortality

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.

Time frame
Up to 28 days

Other outcomes

Sponsors and contacts

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