Community-acquired PneumoniaPhase 3NCT04779242
Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
A Phase 3 study testing Omadacycline and Moxifloxacin in people with Community-acquired Pneumonia and Bacterial Pneumonia, run by Paratek Pharmaceuticals Inc at 55 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Bacterial Pneumonia
- What is being tested?
- Omadacycline and Moxifloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 670 participants
- Where
- 55 sitesin 8 countries
- Study dates
- 25 Feb 2021to 27 Mar 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female subjects, age 18 or older who have signed the informed consent form
- Must have a qualifying community-acquired bacterial pneumonia
- Subjects must not be pregnant or nursing at the time of enrollment
- Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
Who cannot join
- Known or suspected hospital-acquired pneumonia
- Confirmed or suspected SARS-CoV-2 infection
- Evidence of significant immunological disease
- Has a life expectancy of less than or equal to 3 months or any concomitant condition that is likely to interfere with evaluation of the response of the infection under study, determination of AEs, or completion of the expected course of treatment
- Has a history of contraindications, hypersensitivity, or allergic reaction to any tetracycline or fluoroquinolone antibiotic
- Has received an investigational drug within the past 30 days
Trial locations and contacts
55 sites in 8 countries.
55 sites in 8 countries
Bulgaria12 sites
Site 210
Gabrovo
Site 213
Lom
Site 208
Pernik
Site 201
Pleven
Site 206
Rousse
Site 207
Sliven
Site 202
Sofia
Site 204
Sofia
Site 205
Sofia
Site 209
Sofia
Site 212
Vidin
Site 211
Vratsa
Ukraine10 sites
Site 606
Dnipro
Site 602
Kharkiv
Site 604
Kharkiv
Site 611
Kharkiv
Site 603
Kyiv
Site 605
Kyiv
Site 607
Kyiv
Site 609
Kyiv
Site 608
Zaporizhia
Site 610
Zaporizhia
Serbia8 sites
Site 703
Belgrade
Site 704
Belgrade
Site 705
Belgrade
Site 707
Belgrade
Site708
Belgrade
Site 706
Kamenitz
Site 701
Kragujevac
Site 702
Niš
Georgia7 sites
Site 401
Tbilisi
Site 402
Tbilisi
Site 403
Tbilisi
Site 404
Tbilisi
Site 405
Tbilisi
Site 406
Tbilisi
Site 407
Tbilisi
Hungary5 sites
Site 802
Balassagyarmat
Site 801
Budapest
Site 803
Debrecen
Site 804
Kistarcsa
Site 805
Törökbálint
Russia5 sites
Site 506
Moscow
Site 510
Moscow
Site 507
Saint Petersburg
Site 508
Saint Petersburg
Site 509
Saint Petersburg
About this study
Official title: A Phase 3b Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects With Community-Acquired Bacterial Pneumonia (CABP)
The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.
- Conditions
- Community-acquired Pneumonia, Bacterial Pneumonia
- Being tested
- Omadacycline, Moxifloxacin
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmadacyclineDrug
Also called NUZYRA
IV for injection, oral tablets
MoxifloxacinDrug
Also called Avelox
IV solution, oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Omadacycline | Experimental | Omadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration. Receives: Drug: Omadacycline |
| Moxifloxacin | Active comparator | Moxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit
Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in CABP symptoms. Response is determined programmatically using investigator's assessment of the CABP symptoms. The severity of the participant's CABP symptoms was evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Subject Symptom Severity Guidance Framework for Investigator Assessment. An indeterminate response is defined as one that could not be adequately inferred because the participant was not assessed because they withdrew consent, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in 2CABP symptoms, worsening of CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event requiring alternative antibacterial treatment, or death
Measured: 72 to 120 hours after the first dose of test article
Secondary outcomes (2)
Percentage of Participants With Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit
At the PTE Visit, the investigator indicates one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred.
Measured: 5 to 10 days after the last dose of test article
Percentage of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population at the PTE Visit
At the PTE Visit, the investigator indicates one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred.
Measured: 5 to 10 days after the last dose of test article
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start25 Feb 2021
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paratek Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Manley, Study director, Paratek Pharmaceuticals Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779242
- Sponsor's protocol ID
- PTK0796-CABP-19302
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2021
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects With Community-Acquired Bacterial Pneumonia (CABP)
- ClinicalTrials.gov ID
- NCT04779242
- Acronym / sponsor ID
- PTK0796-CABP-19302
- Conditions
- Community-acquired Pneumonia, Bacterial Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Paratek Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Posted 9 Apr 2025
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 evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omadacycline | Experimental | Drug: OmadacyclineOmadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration. |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinMoxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects, age 18 or older who have signed the informed consent form
- Must have a qualifying community-acquired bacterial pneumonia
- Subjects must not be pregnant or nursing at the time of enrollment
- Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
Key exclusion criteria (6 listed)
- Known or suspected hospital-acquired pneumonia
- Confirmed or suspected SARS-CoV-2 infection
- Evidence of significant immunological disease
- Has a life expectancy of less than or equal to 3 months or any concomitant condition that is likely to interfere with evaluation of the response of the infection under study, determination of AEs, or completion of the expected course of treatment
- Has a history of contraindications, hypersensitivity, or allergic reaction to any tetracycline or fluoroquinolone antibiotic
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 |
|---|---|---|
| OmadacyclineAlso: NUZYRAIV for injection, oral tablets | Drug | Omadacycline |
| MoxifloxacinAlso: AveloxIV solution, oral tablets | Drug | Moxifloxacin |
Primary outcome
Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit
Time frame: 72 to 120 hours after the first dose of test article
Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in CABP symptoms. Response is determined programmatically using investigator's assessment of the CABP symptoms. The severity of the participant's CABP symptoms was evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Subject Symptom Severity Guidance Framework for Investigator Assessment. An indeterminate response is defined as one that could not be adequately inferred because the participant was not assessed because they withdrew consent, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in 2CABP symptoms, worsening of CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event requiring alternative antibacterial treatment, or death
2 secondary outcomes
Percentage of Participants With Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit
Time frame: 5 to 10 days after the last dose of test article
Percentage of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population at the PTE Visit
Time frame: 5 to 10 days after the last dose of test article
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Amy Manley study director
Paratek Pharmaceuticals Inc
55 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omadacycline and Moxifloxacin in people with Community-acquired Pneumonia and Bacterial Pneumonia, run by Paratek Pharmaceuticals Inc at 55 sites in 8 countries.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in Bulgaria, Ukraine, Serbia, Georgia, Hungary and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit (time frame: 72 to 120 hours after the first dose of test article). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2025.