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

NCT04779242 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: PTK0796-CABP-19302
• Study Type: interventional
• Target: 670
• Locations: 8 countries
• Sites: 55

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.

Conditions

Community-acquired Pneumonia; Bacterial Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants With Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit

  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

  5 to 10 days after the last dose of test article

Study Arms (2)

Omadacycline

EXPERIMENTAL

Omadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration.

Drug: Omadacycline

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration

Drug: Moxifloxacin

Interventions

Omadacycline DRUG

IV for injection, oral tablets

Also known as: NUZYRA

Omadacycline

Moxifloxacin DRUG

IV solution, oral tablets

Also known as: Avelox

Moxifloxacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paratek Pharmaceuticals Inc: lead

Study Sites (55)

Site 210

Gabrovo, Bulgaria

Location

Site 213

Lom, Bulgaria

Location

Site 208

Pernik, Bulgaria

Location

Site 201

Pleven, Bulgaria

Location

Site 206

Rousse, Bulgaria

Location

Site 207

Sliven, Bulgaria

Location

Site 202

Sofia, Bulgaria

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Site 204

Sofia, Bulgaria

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Site 205

Sofia, Bulgaria

Location

Site 209

Sofia, Bulgaria

Location

Site 212

Vidin, Bulgaria

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Site 211

Vratsa, Bulgaria

Location

Site 302

Split, Croatia

Location

Site 301

Zagreb, Croatia

Location

Site 303

Zagreb, Croatia

Location

Site 304

Zagreb, Croatia

Location

Site 401

Tbilisi, Georgia

Location

Site 402

Tbilisi, Georgia

Location

Site 403

Tbilisi, Georgia

Location

Site 404

Tbilisi, Georgia

Location

Site 405

Tbilisi, Georgia

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Site 406

Tbilisi, Georgia

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Site 407

Tbilisi, Georgia

Location

Site 802

Balassagyarmat, Hungary

Location

Site 801

Budapest, Hungary

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Site 803

Debrecen, Hungary

Location

Site 804

Kistarcsa, Hungary

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Site 805

Törökbálint, Hungary

Location

Site 901

Chrzanów, Poland

Location

Site 904

Krakow, Poland

Location

Site 902

Oświęcim, Poland

Location

Site 903

Łęczna, Poland

Location

Site 506

Moscow, Russia

Location

Site 510

Moscow, Russia

Location

Site 507

Saint Petersburg, Russia

Location

Site 508

Saint Petersburg, Russia

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Site 509

Saint Petersburg, Russia

Location

Site 703

Belgrade, Serbia

Location

Site 704

Belgrade, Serbia

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Site 705

Belgrade, Serbia

Location

Site 707

Belgrade, Serbia

Location

Site708

Belgrade, Serbia

Location

Site 706

Kamenitz, Serbia

Location

Site 701

Kragujevac, Serbia

Location

Site 702

Niš, Serbia

Location

Site 606

Dnipro, Ukraine

Location

Site 602

Kharkiv, Ukraine

Location

Site 604

Kharkiv, Ukraine

Location

Site 611

Kharkiv, Ukraine

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Site 603

Kyiv, Ukraine

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Site 605

Kyiv, Ukraine

Location

Site 607

Kyiv, Ukraine

Location

Site 609

Kyiv, Ukraine

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Site 608

Zaporizhia, Ukraine

Location

Site 610

Zaporizhia, Ukraine

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia, Bacterial

Interventions

omadacycline; Moxifloxacin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Lung Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Paratek Medical Information
• Organization: Paratek Pharmaceuticals Inc

medinfo@paratekpharma.com

1-833-727-2835

Study Officials

• Amy Manley

  Paratek Pharmaceuticals Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: February 25, 2021
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: April 9, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (5); PL (4); UA (10); SE (8); HU (5); BU (12); CR (4); GE (7)