Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Omadacycline Omadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration. |
Drug: Omadacycline
IV for injection, oral tablets
Other Names:
|
| Active Comparator: Moxifloxacin Moxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration |
Drug: Moxifloxacin
IV solution, oral tablets
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of participants with early clinical response in the Intent-to-Treat (ITT) Population at the Early Clinical Response (ECR) visit [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 2 CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in the other CABP symptoms. Response is determined programmatically using the 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, were lost to follow-up, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in CABP symptoms, worsening of any CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event, or death.
Secondary Outcome Measures
- Number of participants with the indicated investigator assessment of clinical response in the Intent-to-Treat (ITT) Population at the Post Therapy Evaluation (PTE) Visit [5 to 10 days after the last dose of test article]
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.
- Number of participants with the indicated investigator assessment of clinical response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population at the Post-Therapy Evaluation (PTE) Visit [5 to 10 days after the last dose of test article]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
Exclusion Criteria:
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Known or suspected hospital-acquired pneumonia
-
Confirmed or suspected SARS-CoV-2 infection
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Evidence of significant immunological disease
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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
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Has a history of contraindications, hypersensitivity, or allergic reaction to any tetracycline or fluoroquinolone antibiotic
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Has received an investigational drug within the past 30 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site 208 | Pernik | Bulgaria | ||
| 2 | Site 201 | Pleven | Bulgaria | ||
| 3 | Site 206 | Ruse | Bulgaria | ||
| 4 | Site 207 | Sliven | Bulgaria | ||
| 5 | Site 202 | Sofia | Bulgaria | ||
| 6 | Site 204 | Sofia | Bulgaria | ||
| 7 | Site 205 | Sofia | Bulgaria | ||
| 8 | Site 209 | Sofia | Bulgaria | ||
| 9 | Site 302 | Split | Croatia | ||
| 10 | Site 301 | Zagreb | Croatia | ||
| 11 | Site 303 | Zagreb | Croatia | ||
| 12 | Site 304 | Zagreb | Croatia | ||
| 13 | Site 401 | Tbilisi | Georgia | ||
| 14 | Site 402 | Tbilisi | Georgia | ||
| 15 | Site 403 | Tbilisi | Georgia | ||
| 16 | Site 404 | Tbilisi | Georgia | ||
| 17 | Site 405 | Tbilisi | Georgia | ||
| 18 | Site 406 | Tbilisi | Georgia | ||
| 19 | Site 506 | Moscow | Russian Federation | ||
| 20 | Site 507 | Saint Petersburg | Russian Federation | ||
| 21 | Site 508 | Saint Petersburg | Russian Federation | ||
| 22 | Site 509 | Saint Petersburg | Russian Federation | ||
| 23 | Site 606 | Dnipro | Ukraine | ||
| 24 | Site 602 | Kharkiv | Ukraine | ||
| 25 | Site 611 | Kharkiv | Ukraine | ||
| 26 | Site 603 | Kyiv | Ukraine | ||
| 27 | Site 605 | Kyiv | Ukraine | ||
| 28 | Site 607 | Kyiv | Ukraine | ||
| 29 | Site 609 | Kyiv | Ukraine | ||
| 30 | Site 608 | Zaporizhia | Ukraine | ||
| 31 | Site 610 | Zaporizhia | Ukraine |
Sponsors and Collaborators
- Paratek Pharmaceuticals Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PTK0796-CABP-19302