Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)

A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia

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: Bacterial Pneumonia; Community-Acquired Infections
• Intervention / Treatment: Drug: Omadacycline; Drug: Moxifloxacin

• Study Type: Interventional
• Enrollment (Actual): 774
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium
    • Site 220
• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Site 276
  • Rio Grande Do Sul
    • Passo Fundo, Rio Grande Do Sul, Brazil
      • Site 277
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Site 274
  • São Paulo
    • São José Do Rio Preto, São Paulo, Brazil
      • Site 279
• Bulgaria
  • Kyustendil, Bulgaria
    • Site 305
  • Pernik, Bulgaria
    • Site 303
  • Plovdiv, Bulgaria
    • Site 304
  • Sliven, Bulgaria
    • Site 306
  • Sofia, Bulgaria
    • Site 301
  • Sofia, Bulgaria
    • Site 302
  • Sofia, Bulgaria
    • Site 307
• Croatia
  • Požega, Croatia
    • Site 250
  • Slavonski Brod, Croatia
    • Site 205
  • Zadar, Croatia
    • Site 212
  • Zagreb, Croatia
    • Site 201
  • Zagreb, Croatia
    • Site 202
  • Zagreb, Croatia
    • Site 203
  • Zagreb, Croatia
    • Site 251
  • Zagreb, Croatia
    • Site 405
• Czechia
  • Kyjov, Czechia
    • Site 412
  • Praha 10, Czechia
    • Site 411
  • Praha 5, Czechia
    • Site 410
  • Trebic, Czechia
    • Site 414
• Georgia
  • T'bilisi, Georgia
    • Site 392
  • Tbilisi, Georgia
    • Site 390
  • Tbilisi, Georgia
    • Site 391
  • Tbilisi, Georgia
    • Site 393
  • Tbilisi, Georgia
    • Site 394
• Germany
  • Heidelberg, Germany
    • Site 415
  • Jena, Germany
    • Site 416
  • Paderborn, Germany
    • Site 417
• Greece
  • Athens, Greece
    • Site 210
  • Athens, Greece
    • Site 421
  • Thessaloniki, Greece
    • Site 208
  • Attika
    • Athens, Attika, Greece
      • Site 207
    • Athens, Attika, Greece
      • Site 420
• Hungary
  • Budapest, Hungary
    • Site 310
  • Budapest, Hungary
    • Site 311
  • Budapest, Hungary
    • Site 312
  • Debrecen, Hungary
    • Site 314
  • Miskolc, Hungary
    • Site 316
  • Nyíregyháza, Hungary
    • Site 313
  • Szekesfehervar, Hungary
    • Site 315
• Israel
  • Holon, Israel
    • Site 213
  • Nazareth, Israel
    • Site 214
  • Petach-Tikwa, Israel
    • Site 217
  • Ramat-Gan, Israel
    • Site 215
  • Safed, Israel
    • Site 216
• Korea, Republic of
  • Daegu, Korea, Republic of
    • Site 293
  • Seoul, Korea, Republic of
    • Site 291
  • Seoul, Korea, Republic of
    • Site 292
  • Seoul, Korea, Republic of
    • Site 294
• Latvia
  • Daugavpils, Latvia
    • Site 322
  • Liepaja, Latvia
    • Site 323
  • Riga, Latvia
    • Site 320
  • Riga, Latvia
    • Site 321
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico
      • Site 228
    • Guadalajara, Jalisco, Mexico
      • Site 472
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico
      • Site 227
    • Monterrey, Nuevo Leon, Mexico
      • Site 471
  • Veracruz
    • Xalapa, Veracruz, Mexico
      • Site 230
• Peru
  • Cusco, Peru
    • Site 234
  • Lima, Peru
    • Site 233
  • Lima, Peru
    • Site 236
  • Lima, Peru
    • Site 238
  • Lima, Peru
    • Site 239
  • Lima, Peru
    • Site 481
  • Trujillo, Peru
    • Site 237
• Philippines
  • Caloocan City, Philippines
    • Site 555
  • Iloilo City, Philippines
    • 552
  • Manila City, Philippines
    • 554
  • Quezon City, Philippines
    • Site 551
  • Quezon City, Philippines
    • Site 553
• Poland
  • Chrzanow, Poland
    • Site 332
  • Katowice, Poland
    • Site 333
  • Leczna, Poland
    • Site 334
  • Wroclaw, Poland
    • Site 331
  • Łódź, Poland
    • Site 330
• Romania
  • Brasov, Romania
    • Site 344
  • Bucharest, Romania
    • Site 340
  • Bucharest, Romania
    • Site 342
  • Bucharest, Romania
    • Site 343
  • Craiova, Romania
    • Site 345
  • Timisoara, Romania
    • Site 341
• Russian Federation
  • Moscow, Russian Federation
    • 352
  • Moscow, Russian Federation
    • Site 350
  • Moscow, Russian Federation
    • Site 351
  • Saint Petersburg, Russian Federation
    • Site 353
  • Saint Petersburg, Russian Federation
    • Site 354
  • Saint Petersburg, Russian Federation
    • Site 355
  • Saint Petersburg, Russian Federation
    • Site 356
  • Sestroretsk, Russian Federation
    • 357
  • Vsevolozhsk, Russian Federation
    • Site 358
  • Zelenograd, Russian Federation
    • Site 359
• Slovakia
  • Bratislava, Slovakia
    • Site 431
  • Levice, Slovakia
    • Site 430
  • Martin, Slovakia
    • Site 432
  • Nitra, Slovakia
    • Site 433
• South Africa
  • Gauteng
    • Benoni, Gauteng, South Africa
      • Site 241
    • Centurion, Gauteng, South Africa
      • Site 436
  • Guateng
    • Pretoria, Guateng, South Africa
      • Site 242
  • Limpopo
    • Thabazimbi, Limpopo, South Africa
      • Site 244
  • Mpumalanga
    • Middelburg, Mpumalanga, South Africa
      • Site 245
  • Western Cape
    • Somerset West, Western Cape, South Africa
      • Site 437
• Spain
  • Alicante, Spain
    • Site 226
  • Alicante
    • Elche, Alicante, Spain
      • Site 225
  • Cataluña
    • Barcelona, Cataluña, Spain
      • Site 221
    • Barcelona, Cataluña, Spain
      • Site 440
  • Valencia
    • Alcira, Valencia, Spain
      • Site 224
• Taiwan
  • Kaohsiung, Taiwan
    • Site 299
  • Tainan, Taiwan
    • Site 297
  • Taipei, Taiwan
    • Site 295
  • Taipei, Taiwan
    • Site 296
  • Taipei, Taiwan
    • Site 298
• Turkey
  • Ankara, Turkey
    • Site 247
  • Ankara, Turkey
    • Site 248
  • Ankara, Turkey
    • Site 249
  • Trabzon, Turkey
    • Site 246
• Ukraine
  • Dnipropetrovs'k, Ukraine
    • Site 380
  • Dnipropetrovsk, Ukraine
    • Site 373
  • Kharkiv, Ukraine
    • Site 374
  • Kharkiv, Ukraine
    • Site 375
  • Kyiv, Ukraine
    • Site 370
  • Kyiv, Ukraine
    • Site 372
  • Kyiv, Ukraine
    • Site 378
  • Kyiv, Ukraine
    • Site 379
  • Zaporizhia, Ukraine
    • Site 376
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35215
      • Site 514
    • Mobile, Alabama, United States, 36608
      • Site 501
  • California
    • Laguna Hills, California, United States, 92653
      • Site 508
    • Ventura, California, United States, 93003
      • Site 505
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Site 513
  • Louisiana
    • Zachary, Louisiana, United States, 70791
      • Site 511
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Site 503
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Site 520
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Site 512
  • New York
    • Buffalo, New York, United States, 14215
      • Site 506
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Site 509
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Site 516

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients, ages 18 years or older who have signed the informed consent
• Has qualifying bacterial pneumonia
• Female patients must not be pregnant 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
• Evidence of significant immunological disease
• Has a history of hypersensitivity or allergic reaction to any tetracycline or to any fluoroquinolone antibiotic
• Has received an investigational drug within past 30 days
• Women who are pregnant or nursing

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 IV; Omadacycline tablets	Drug: Omadacycline; Injection for IV; Oral tablets
Active Comparator: Moxifloxacin; Moxifloxacin IV; Moxifloxacin tablets	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	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 was 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.	Screening; 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 ITT Population at the Post Therapy Evaluation (PTE) Visit	At the PTE Visit the investigator indicated 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.	Screening; 5 to 10 days after the last day of therapy
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CT-PTE) Population	At the PTE Visit the investigator indicated 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.	Screening; 5 to 10 days after the last day of therapy

Collaborators and Investigators

• Sponsor: Paratek Pharmaceuticals Inc

Publications and helpful links

General Publications

• Cornely OA, File TM Jr, Garrity-Ryan L, Chitra S, Noble R, McGovern PC. Safety and efficacy of omadacycline for treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in patients with mild-to-moderate renal impairment. Int J Antimicrob Agents. 2021 Feb;57(2):106263. doi: 10.1016/j.ijantimicag.2020.106263. Epub 2020 Dec 14.
• Vacalis S, Brunton S, Gindi J. Omadacycline in Skin Infections and Pneumonia: A Review of the Evidence. J Fam Pract. 2022 Jun;71(5 Suppl):S10-S21. doi: 10.12788/jfp.0424.
• Ramirez JA, Tzanis E, Curran M, Noble R, Chitra S, Manley A, Kirsch C, McGovern PC. Early Clinical Response in Community-acquired Bacterial Pneumonia: From Clinical Endpoint to Clinical Practice. Clin Infect Dis. 2019 Aug 1;69(Suppl 1):S33-S39. doi: 10.1093/cid/ciz397.
• Stets R, Popescu M, Gonong JR, Mitha I, Nseir W, Madej A, Kirsch C, Das AF, Garrity-Ryan L, Steenbergen JN, Manley A, Eckburg PB, Tzanis E, McGovern PC, Loh E. Omadacycline for Community-Acquired Bacterial Pneumonia. N Engl J Med. 2019 Feb 7;380(6):517-527. doi: 10.1056/NEJMoa1800201.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): February 5, 2017
• Study Completion (Actual): March 10, 2017

Study Registration Dates

• First Submitted: July 14, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (Estimate): August 24, 2015

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial; Community-Acquired Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: PTK0796-CABP-1200