A Phase 3 interventional study of Omadacycline and Moxifloxacin in Community-acquired Pneumonia and Bacterial Pneumonia, sponsored by Paratek Pharmaceuticals Inc. Completed at 55 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Paratek Pharmaceuticals Inc · Phase 3, Interventional, and Treatment
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.
324 studies on the registry are indexed under Community-Acquired Pneumonia; 77 are open to participants now.
This study's enrollment of 670 is above the median of 250 across 195 interventional studies indexed under Community-Acquired Pneumonia.
Browse Community-Acquired Pneumonia studies →Paratek Pharmaceuticals Inc is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Omadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration.
Drug: Omadacycline
Moxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration
Drug: Moxifloxacin
IV for injection, oral tablets
Also known as: NUZYRA
IV solution, oral tablets
Also known as: Avelox
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
Time frame: 72 to 120 hours after the first dose of test article
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.
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
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.
Time frame: 5 to 10 days after the last dose of test article
This is a randomized, double-blind, active comparator-controlled study comparing Omadacycline and Moxifloxacin with participants with Community-Acquired Bacterial Pneumonia (CABP). The randomization was stratified by Pneumonia Outcomes Research Team (PORT) Risk Class (III or IV), and receipt of an allowed antibacterial therapy in the 72 hours prior to study treatment.
| Milestone | Omadacycline | Moxifloxacin |
|---|---|---|
| Started | 336 | 334 |
| Completed | 308 | 306 |
| Not completed | 28 | 28 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Lost to follow-up | 2 | 4 |
| Withdrew: Withdrawal by subject | 7 | 9 |
| Withdrew: Death | 6 | 6 |
| Withdrew: Covid-19 related reasons | 2 | 1 |
| Withdrew: Unavailability for post therapy evaluation visit | 8 | 4 |
| Withdrew: Martial law in ukraine | 2 | 3 |
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
| Percentage of participants | Omadacycline | Moxifloxacin |
|---|---|---|
| Clinical Success | 89.6 | 87.7 |
| Clinical Failure | 8.6 | 9.3 |
| Indeterminate | 1.8 | 3.0 |
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.
| Percentage of participants | Omadacycline | Moxifloxacin |
|---|---|---|
| Clinical Success | 86 | 87.7 |
| Clinical Failure | 8.0 | 6.6 |
| Indeterminate | 6.0 | 5.7 |
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.
| Percentage of participants | Omadacycline | Moxifloxacin |
|---|---|---|
| Clinical Success | 94.1 | 95.9 |
| Clinical Failure | 5.9 | 4.1 |
| Indeterminate | 0 | 0 |
Collected over Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omadacycline | 6/336 (1.8%) | 17/336 (5.1%) | 32/336 (9.5%) |
| Moxifloxacin | 6/332 (1.8%) | 15/332 (4.5%) | 36/332 (10.8%) |
| Event | Omadacycline | Moxifloxacin |
|---|---|---|
| Cardiac failureCardiac disorders | 1/336 | 2/332 |
| Cardiac arrestCardiac disorders | 0/336 | 2/332 |
| PneumoniaInfections and infestations | 2/336 | 2/332 |
| COVID-19Infections and infestations | 1/336 | 2/332 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 0/336 | 2/332 |
| Cardiopulmonary failureCardiac disorders | 0/336 | 1/332 |
| Multiple organ dysfunction syndromeGeneral disorders | 0/336 | 1/332 |
| Septic shockInfections and infestations | 1/336 | 1/332 |
| EmpyemaInfections and infestations | 0/336 | 1/332 |
| Lung abscessInfections and infestations | 0/336 | 1/332 |
| Event | Omadacycline | Moxifloxacin |
|---|---|---|
| HeadacheNervous system disorders | 12/336 | 15/332 |
| COVID-19Infections and infestations | 11/336 | 4/332 |
| DiarrhoeaGastrointestinal disorders | 0/336 | 10/332 |
| InsomniaPsychiatric disorders | 2/336 | 7/332 |
| Aspartate aminotransferase increasedInvestigations | 7/336 | 0/332 |
Intent-to Treat (ITT) population consisted of all randomized participants regardless of whether or not the participant received test article.
| Age, Continuous(Years) | Omadacycline | Moxifloxacin | Total |
|---|---|---|---|
| Mean | 63.3 ± 14.41 | 62.2 ± 15.42 | 62.8 ± 14.92 |
| Sex: Female, Male(Participants) | Omadacycline | Moxifloxacin | Total |
|---|---|---|---|
| Female | 158 | 166 | 324 |
| Male | 178 | 168 | 346 |
| Ethnicity (NIH/OMB)(Participants) | Omadacycline | Moxifloxacin | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 4 | 8 |
| Not Hispanic or Latino | 332 | 330 | 662 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Omadacycline | Moxifloxacin | Total |
|---|---|---|---|
| White | 335 | 333 | 668 |
| Asian | 1 | 1 | 2 |
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Studies of the drug tested here: Omadacycline
Community-Acquired Pneumonia →
Paratek Pharmaceuticals Inc