Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
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| ClinicalTrials.gov Identifier: NCT04779242 |
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Recruitment Status :
Recruiting
First Posted : March 3, 2021
Last Update Posted : March 10, 2022
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Sponsor:
Paratek Pharmaceuticals Inc
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc
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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 |
|---|---|---|
| Community-acquired Pneumonia Bacterial Pneumonia | Drug: Omadacycline Drug: Moxifloxacin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 670 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | February 25, 2021 |
| Estimated Primary Completion Date : | November 2022 |
| Estimated Study Completion Date : | December 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Omadacycline
Omadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration.
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Drug: Omadacycline
IV for injection, oral tablets
Other Name: NUZYRA |
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Active Comparator: Moxifloxacin
Moxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration
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Drug: Moxifloxacin
IV solution, oral tablets
Other Name: Avelox |
Primary Outcome Measures :
- Number of participants with early clinical response in the Intent-to-Treat (ITT) Population 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 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 [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
- 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:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04779242
Contacts
| Contact: Courtney Kirsch | 484 751 4925 | courtney.kirsch@paratekpharma.com | |
| Contact: Amy Manley | amy.manley@paratekpharma.com |
Locations
Show 30 study locations
Sponsors and Collaborators
Paratek Pharmaceuticals Inc
| Responsible Party: | Paratek Pharmaceuticals Inc |
| ClinicalTrials.gov Identifier: | NCT04779242 |
| Other Study ID Numbers: |
PTK0796-CABP-19302 |
| First Posted: | March 3, 2021 Key Record Dates |
| Last Update Posted: | March 10, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Pneumonia Pneumonia, Bacterial Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Bacterial Infections Bacterial Infections and Mycoses |
Moxifloxacin Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |