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

Last updated: March 20, 2025
Sponsor: Paratek Pharmaceuticals Inc
Overall Status: Completed

Phase

3

Condition

Pneumonia

Pneumonia (Pediatric)

Treatment

Moxifloxacin

Omadacycline

Clinical Study ID

NCT04779242
PTK0796-CABP-19302
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 daysfollowing the last dose of study drug

Exclusion

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 conditionthat is likely to interfere with evaluation of the response of the infection understudy, determination of AEs, or completion of the expected course of treatment

  • Has a history of contraindications, hypersensitivity, or allergic reaction to anytetracycline or fluoroquinolone antibiotic

  • Has received an investigational drug within the past 30 days

Study Design

Total Participants: 670
Treatment Group(s): 2
Primary Treatment: Moxifloxacin
Phase: 3
Study Start date:
February 25, 2021
Estimated Completion Date:
March 27, 2024

Connect with a study center

  • Site 210

    Gabrovo,
    Bulgaria

    Site Not Available

  • Site 213

    Lom,
    Bulgaria

    Site Not Available

  • Site 208

    Pernik,
    Bulgaria

    Site Not Available

  • Site 201

    Pleven,
    Bulgaria

    Site Not Available

  • Site 206

    Ruse,
    Bulgaria

    Site Not Available

  • Site 207

    Sliven,
    Bulgaria

    Site Not Available

  • Site 202

    Sofia,
    Bulgaria

    Site Not Available

  • Site 204

    Sofia,
    Bulgaria

    Site Not Available

  • Site 205

    Sofia,
    Bulgaria

    Site Not Available

  • Site 209

    Sofia,
    Bulgaria

    Site Not Available

  • Site 212

    Vidin,
    Bulgaria

    Site Not Available

  • Site 211

    Vratsa,
    Bulgaria

    Site Not Available

  • Site 302

    Split,
    Croatia

    Site Not Available

  • Site 301

    Zagreb,
    Croatia

    Site Not Available

  • Site 303

    Zagreb,
    Croatia

    Site Not Available

  • Site 304

    Zagreb,
    Croatia

    Site Not Available

  • Site 401

    Tbilisi,
    Georgia

    Site Not Available

  • Site 402

    Tbilisi,
    Georgia

    Site Not Available

  • Site 403

    Tbilisi,
    Georgia

    Site Not Available

  • Site 404

    Tbilisi,
    Georgia

    Site Not Available

  • Site 405

    Tbilisi,
    Georgia

    Site Not Available

  • Site 406

    Tbilisi,
    Georgia

    Site Not Available

  • Site 407

    Tbilisi,
    Georgia

    Site Not Available

  • Site 802

    Balassagyarmat,
    Hungary

    Site Not Available

  • Site 801

    Budapest,
    Hungary

    Site Not Available

  • Site 803

    Debrecen,
    Hungary

    Site Not Available

  • Site 804

    Kistarcsa,
    Hungary

    Site Not Available

  • Site 805

    Torokbalint,
    Hungary

    Site Not Available

  • Site 901

    Chrzanow,
    Poland

    Site Not Available

  • Site 904

    Krakow,
    Poland

    Site Not Available

  • Site 903

    Leczna,
    Poland

    Site Not Available

  • Site 902

    Oswiecim,
    Poland

    Site Not Available

  • Site 506

    Moscow,
    Russian Federation

    Site Not Available

  • Site 510

    Moscow,
    Russian Federation

    Site Not Available

  • Site 507

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Site 508

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Site 509

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Site 703

    Belgrade,
    Serbia

    Site Not Available

  • Site 704

    Belgrade,
    Serbia

    Site Not Available

  • Site 705

    Belgrade,
    Serbia

    Site Not Available

  • Site 707

    Belgrade,
    Serbia

    Site Not Available

  • Site708

    Belgrade,
    Serbia

    Site Not Available

  • Site 701

    Kragujevac,
    Serbia

    Site Not Available

  • Site 702

    Niš,
    Serbia

    Site Not Available

  • Site 706

    Sremska Kamenica,
    Serbia

    Site Not Available

  • Site 606

    Dnipro,
    Ukraine

    Site Not Available

  • Site 602

    Kharkiv,
    Ukraine

    Site Not Available

  • Site 604

    Kharkiv,
    Ukraine

    Site Not Available

  • Site 611

    Kharkiv,
    Ukraine

    Site Not Available

  • Site 603

    Kyiv,
    Ukraine

    Site Not Available

  • Site 605

    Kyiv,
    Ukraine

    Site Not Available

  • Site 607

    Kyiv,
    Ukraine

    Site Not Available

  • Site 609

    Kyiv,
    Ukraine

    Site Not Available

  • Site 608

    Zaporizhia,
    Ukraine

    Site Not Available

  • Site 610

    Zaporizhia,
    Ukraine

    Site Not Available

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