Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia

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.

Study Overview

• Status: Completed
• Conditions: Community-acquired Pneumonia; Bacterial Pneumonia
• Intervention / Treatment: Drug: Omadacycline; Drug: Moxifloxacin

• Study Type: Interventional
• Enrollment (Actual): 670
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Gabrovo, Bulgaria
    • Site 210
  • Lom, Bulgaria
    • Site 213
  • Pernik, Bulgaria
    • Site 208
  • Pleven, Bulgaria
    • Site 201
  • Ruse, Bulgaria
    • Site 206
  • Sliven, Bulgaria
    • Site 207
  • Sofia, Bulgaria
    • Site 202
  • Sofia, Bulgaria
    • Site 204
  • Sofia, Bulgaria
    • Site 205
  • Sofia, Bulgaria
    • Site 209
  • Vidin, Bulgaria
    • Site 212
  • Vratsa, Bulgaria
    • Site 211
• Croatia
  • Split, Croatia
    • Site 302
  • Zagreb, Croatia
    • Site 301
  • Zagreb, Croatia
    • Site 303
  • Zagreb, Croatia
    • Site 304
• Georgia
  • Tbilisi, Georgia
    • Site 401
  • Tbilisi, Georgia
    • Site 402
  • Tbilisi, Georgia
    • Site 403
  • Tbilisi, Georgia
    • Site 404
  • Tbilisi, Georgia
    • Site 405
  • Tbilisi, Georgia
    • Site 406
  • Tbilisi, Georgia
    • Site 407
• Hungary
  • Balassagyarmat, Hungary
    • Site 802
  • Budapest, Hungary
    • Site 801
  • Debrecen, Hungary
    • Site 803
  • Kistarcsa, Hungary
    • Site 804
  • Torokbalint, Hungary
    • Site 805
• Poland
  • Chrzanow, Poland
    • Site 901
  • Krakow, Poland
    • Site 904
  • Leczna, Poland
    • Site 903
  • Oswiecim, Poland
    • Site 902
• Russian Federation
  • Moscow, Russian Federation
    • Site 506
  • Moscow, Russian Federation
    • Site 510
  • Saint Petersburg, Russian Federation
    • Site 507
  • Saint Petersburg, Russian Federation
    • Site 508
  • Saint Petersburg, Russian Federation
    • Site 509
• Serbia
  • Belgrade, Serbia
    • Site 703
  • Belgrade, Serbia
    • Site 704
  • Belgrade, Serbia
    • Site 705
  • Belgrade, Serbia
    • Site 707
  • Belgrade, Serbia
    • Site708
  • Kragujevac, Serbia
    • Site 701
  • Niš, Serbia
    • Site 702
  • Sremska Kamenica, Serbia
    • Site 706
• Ukraine
  • Dnipro, Ukraine
    • Site 606
  • Kharkiv, Ukraine
    • Site 602
  • Kharkiv, Ukraine
    • Site 604
  • Kharkiv, Ukraine
    • Site 611
  • Kyiv, Ukraine
    • Site 603
  • Kyiv, Ukraine
    • Site 605
  • Kyiv, Ukraine
    • Site 607
  • Kyiv, Ukraine
    • Site 609
  • Zaporizhia, Ukraine
    • Site 608
  • Zaporizhia, Ukraine
    • Site 610

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: NUZYRA
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: Avelox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	72 to 120 hours after the first dose of test article

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	5 to 10 days after the last dose of test article

Collaborators and Investigators

• Sponsor: Paratek Pharmaceuticals Inc
• Investigators: Study Director: Amy Manley, Paratek Pharmaceuticals Inc

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): March 27, 2024
• Study Completion (Actual): March 27, 2024

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial; Anti-Bacterial Agents; Anti-Infective Agents; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Topoisomerase Inhibitors; Topoisomerase II Inhibitors; Moxifloxacin
• Other Study ID Numbers: PTK0796-CABP-19302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No