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
1 other identifier
interventional
774
25 countries
140
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2015
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2015
CompletedFirst Posted
Study publicly available on registry
August 24, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2017
CompletedResults Posted
Study results publicly available
November 29, 2018
CompletedJanuary 16, 2019
January 1, 2019
1.3 years
July 14, 2015
November 2, 2018
January 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the ITT Population at the Post Therapy Evaluation (PTE) Visit
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
Screening; 5 to 10 days after the last day of therapy
Study Arms (2)
Omadacycline
EXPERIMENTALOmadacycline IV; Omadacycline tablets
Moxifloxacin
ACTIVE COMPARATORMoxifloxacin IV; Moxifloxacin tablets
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (140)
Site 514
Birmingham, Alabama, 35215, United States
Site 501
Mobile, Alabama, 36608, United States
Site 508
Laguna Hills, California, 92653, United States
Site 505
Ventura, California, 93003, United States
Site 513
Stamford, Connecticut, 06902, United States
Site 511
Zachary, Louisiana, 70791, United States
Site 503
Detroit, Michigan, 48202, United States
Site 520
Saint Paul, Minnesota, 55101, United States
Site 512
St Louis, Missouri, 63110, United States
Site 506
Buffalo, New York, 14215, United States
Site 509
Dayton, Ohio, 45409, United States
Site 516
Huntington, West Virginia, 25701, United States
Site 220
Liège, Belgium
Site 276
Belo Horizonte, Minas Gerais, Brazil
Site 277
Passo Fundo, Rio Grande do Sul, Brazil
Site 274
Porto Alegre, Rio Grande do Sul, Brazil
Site 279
São José do Rio Preto, São Paulo, Brazil
Site 305
Kyustendil, Bulgaria
Site 303
Pernik, Bulgaria
Site 304
Plovdiv, Bulgaria
Site 306
Sliven, Bulgaria
Site 301
Sofia, Bulgaria
Site 302
Sofia, Bulgaria
Site 307
Sofia, Bulgaria
Site 250
Požega, Croatia
Site 205
Slavonski Brod, Croatia
Site 212
Zadar, Croatia
Site 201
Zagreb, Croatia
Site 202
Zagreb, Croatia
Site 203
Zagreb, Croatia
Site 251
Zagreb, Croatia
Site 405
Zagreb, Croatia
Site 412
Kyjov, Czechia
Site 410
Prague, Czechia
Site 411
Prague, Czechia
Site 414
Třebíč, Czechia
Site 390
Tbilisi, Georgia
Site 391
Tbilisi, Georgia
Site 392
Tbilisi, Georgia
Site 393
Tbilisi, Georgia
Site 394
Tbilisi, Georgia
Site 415
Heidelberg, Germany
Site 416
Jena, Germany
Site 417
Paderborn, Germany
Site 207
Athens, Attica, Greece
Site 420
Athens, Attica, Greece
Site 210
Athens, Greece
Site 421
Athens, Greece
Site 208
Thessaloniki, Greece
Site 310
Budapest, Hungary
Site 311
Budapest, Hungary
Site 312
Budapest, Hungary
Site 314
Debrecen, Hungary
Site 316
Miskolc, Hungary
Site 313
Nyíregyháza, Hungary
Site 315
Székesfehérvár, Hungary
Site 213
Holon, Israel
Site 214
Nazareth, Israel
Site 217
Petah Tikva, Israel
Site 215
Ramat Gan, Israel
Site 216
Safed, Israel
Site 322
Daugavpils, Latvia
Site 323
Liepāja, Latvia
Site 320
Riga, Latvia
Site 321
Riga, Latvia
Site 228
Guadalajara, Jalisco, Mexico
Site 472
Guadalajara, Jalisco, Mexico
Site 227
Monterrey, Nuevo León, Mexico
Site 471
Monterrey, Nuevo León, Mexico
Site 230
Xalapa, Veracruz, Mexico
Site 234
Cusco, Peru
Site 233
Lima, Peru
Site 236
Lima, Peru
Site 238
Lima, Peru
Site 239
Lima, Peru
Site 481
Lima, Peru
Site 237
Trujillo, Peru
Site 555
Caloocan, Philippines
552
Iloilo City, Philippines
554
Manila, Philippines
Site 551
Quezon City, Philippines
Site 553
Quezon City, Philippines
Site 332
Chrzanów, Poland
Site 333
Katowice, Poland
Site 330
Lodz, Poland
Site 331
Wroclaw, Poland
Site 334
Łęczna, Poland
Site 344
Brasov, Romania
Site 340
Bucharest, Romania
Site 342
Bucharest, Romania
Site 343
Bucharest, Romania
Site 345
Craiova, Romania
Site 341
Timișoara, Romania
352
Moscow, Russia
Site 350
Moscow, Russia
Site 351
Moscow, Russia
Site 353
Saint Petersburg, Russia
Site 354
Saint Petersburg, Russia
Site 355
Saint Petersburg, Russia
Site 356
Saint Petersburg, Russia
357
Sestroretsk, Russia
Site 358
Vsevolozhsk, Russia
Site 359
Zelenograd, Russia
Site 431
Bratislava, Slovakia
Site 430
Levice, Slovakia
Site 432
Martin, Slovakia
Site 433
Nitra, Slovakia
Site 241
Benoni, Gauteng, South Africa
Site 436
Centurion, Gauteng, South Africa
Site 242
Pretoria, Guateng, South Africa
Site 244
Thabazimbi, Limpopo, South Africa
Site 245
Middelburg, Mpumalanga, South Africa
Site 437
Somerset West, Western Cape, South Africa
Site 293
Daegu, South Korea
Site 291
Seoul, South Korea
Site 292
Seoul, South Korea
Site 294
Seoul, South Korea
Site 225
Elche, Alicante, Spain
Site 221
Barcelona, Catalonia, Spain
Site 440
Barcelona, Catalonia, Spain
Site 224
Alzira, Valencia, Spain
Site 226
Alicante, Spain
Site 299
Kaohsiung City, Taiwan
Site 297
Tainan, Taiwan
Site 295
Taipei, Taiwan
Site 296
Taipei, Taiwan
Site 298
Taipei, Taiwan
Site 247
Ankara, Turkey (Türkiye)
Site 248
Ankara, Turkey (Türkiye)
Site 249
Ankara, Turkey (Türkiye)
Site 246
Trabzon, Turkey (Türkiye)
Site 380
Dnipro, Ukraine
Site 373
Dnipropetrovsk, Ukraine
Site 374
Kharkiv, Ukraine
Site 375
Kharkiv, Ukraine
Site 370
Kyiv, Ukraine
Site 372
Kyiv, Ukraine
Site 378
Kyiv, Ukraine
Site 379
Kyiv, Ukraine
Site 376
Zaporizhia, Ukraine
Related Publications (5)
Rodriguez GD, Warren N, Yashayev R, Chitra S, Amodio-Groton M, Wright K. Omadacycline in the treatment of community-acquired bacterial pneumonia in patients with comorbidities: a post-hoc analysis of the phase 3 OPTIC trial. Front Med (Lausanne). 2023 Jul 28;10:1225710. doi: 10.3389/fmed.2023.1225710. eCollection 2023.
PMID: 37575994DERIVEDVacalis 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.
PMID: 35776862DERIVEDCornely 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.
PMID: 33326848DERIVEDRamirez 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.
PMID: 31367741DERIVEDStets 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.
PMID: 30726692DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Paul McGovern; Vice President, Clinical Affairs
- Organization
- Paratek Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- 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
July 14, 2015
First Posted
August 24, 2015
Study Start
November 1, 2015
Primary Completion
February 5, 2017
Study Completion
March 10, 2017
Last Updated
January 16, 2019
Results First Posted
November 29, 2018
Record last verified: 2019-01