Community-acquired PneumoniaPhase 4AD-CAPNCT07164131
Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
A Phase 4 study testing Doxycycline and Azithromycin in people with Community-acquired Pneumonia, run by Mayo Clinic at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Doxycycline and Azithromycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,120 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Sep 2025to 1 Sep 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 (> 450 ms in men and > 460 ms in women)
- Incarcerated individuals (prisoner)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Swetha Reddy
- Not yet recruiting
Mayo Clinic Health System-La Crosse
La Crosse, Wisconsin, 54601
Melissa K Myers
- Not yet recruiting
Mayo Clinic Health System-Mankato
Mankato, Minnesota, 56001
Mohamad El Labban
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Amy Amsbaugh, 507-538-7538, amsbaugh.amy@mayo.edu
Yewande Efunpeju Odeyemi
- Not yet recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Cyril Varghese
About this study
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.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Doxycycline, Azithromycin
- Keywords
- Azithromycin, Doxycycline, hospitalized
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Subjects will receive Doxycycline (orally or intravenously) in combination with beta-lactam therapy within 12 hours of hospital admission. Treatment duration will be determined by treating clinician (5-7 days per guidelines).
AzithromycinDrug
Subjects will receive Azithromycin (orally or intravenously) in combination with beta-lactam therapy within 12 hours of hospital admission. Treatment duration will be determined by treating clinician (5-7 days per guidelines).
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline group | Active comparator | Subjects hospitalized for community acquired pneumonia will receive standard of care treatment with Doxycycline Receives: Drug: Doxycycline |
| Azithromycin group | Active comparator | Subjects hospitalized for community acquired pneumonia will receive standard of care treatment with Azithromycin Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive and out of hospital
Days alive spent outside of the hospital, within 28 days of randomization
Measured: 28 days
Secondary outcomes (7)
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
Measured: 28 days
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.
Measured: 28 days
Need for Advanced Respiratory Support
Need for advanced respiratory support including invasive mechanical ventilation, non-invasive mechanical ventilation, high flow nasal cannula,
Measured: 28 days
In-Hospital Mortality
Mortality during hospitalization
Measured: 28 days
Ordinal clinical status scale
Change from baseline on an ordinal clinical status scale from hospitalized, not requiring supplemental oxygen, to death
Measured: 28 days
60-day Mortality
Defined as mortality at 60 days after discharge
Measured: 60 days post discharge
180-day mortality
Defined as mortality at 180 days after discharge
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start15 Sep 2025
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ognjen Gajic, Mayo Clinic
- Investigators
- Ognjen Gajic, MD MS, Principal investigator, Mayo ClinicYewande Odeyemi, MBBS MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164131
- Sponsor's protocol ID
- 24-006503
- Other IDs
- 1R61HL183016-01A1
- Acronym
- AD-CAP
- Status last verified
- Jun 2026
- First submitted
- 20 Aug 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data and the accompanying data dictionary will be made available in a secure, controlled-access data repository within one year of publication. Statistical code (R scripts) and supporting documentation will be shared via GitHub to enable transparency and reproducibility.
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.
PubMed 42509011
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
- ClinicalTrials.gov ID
- NCT07164131
- Acronym / sponsor ID
- AD-CAP / 24-006503
- Conditions
- Community-acquired Pneumonia
- Keywords
- Azithromycin, Doxycycline, hospitalized
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline group | Active comparator | Drug: DoxycyclineSubjects hospitalized for community acquired pneumonia will receive standard of care treatment with Doxycycline |
| Azithromycin group | Active comparator | Drug: AzithromycinSubjects hospitalized for community acquired pneumonia will receive standard of care treatment with Azithromycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineSubjects will receive Doxycycline (orally or intravenously) in combination with beta-lactam therapy within 12 hours of hospital admission. Treatment duration will be determined by treating clinician (5-7 days per guidelines). | Drug | Doxycycline group |
| AzithromycinSubjects will receive Azithromycin (orally or intravenously) in combination with beta-lactam therapy within 12 hours of hospital admission. Treatment duration will be determined by treating clinician (5-7 days per guidelines). | Drug | Azithromycin group |
Primary outcome
Days alive and out of hospital
Time frame: 28 days
Days alive spent outside of the hospital, within 28 days of randomization
7 secondary outcomes
Oxygen-free days
Time frame: 28 days
Need for advanced respiratory support or in-hospital mortality
Time frame: 28 days
Need for Advanced Respiratory Support
Time frame: 28 days
In-Hospital Mortality
Time frame: 28 days
Ordinal clinical status scale
Time frame: 28 days
60-day Mortality
Time frame: 60 days post discharge
180-day mortality
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Derived from this study: PubMed 42509011Tekin 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data and the accompanying data dictionary will be made available in a secure, controlled-access data repository within one year of publication. Statistical code (R scripts) and supporting documentation will be shared via GitHub to enable transparency and reproducibility.
Related trials for Community-acquired Pneumonia
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Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
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Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
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Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ognjen Gajic, MD MS principal investigator
Mayo Clinic
Yewande Odeyemi, MBBS MS principal investigator
Mayo Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxycycline and Azithromycin in people with Community-acquired Pneumonia, run by Mayo Clinic at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Amsbaugh, RRT (5075387538, amsbaugh.amy@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive and out of hospital (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07164131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.