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

March 14, 2024 updated by: Paratek Pharmaceuticals Inc

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

670

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
72 to 120 hours after the first dose of test article

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paratek Pharmaceuticals Inc

Investigators

  • Study Director: Amy Manley, Paratek Pharmaceuticals Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2021

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 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)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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