Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
NCT ID: NCT02531438
Last Updated: 2019-01-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
774 participants
INTERVENTIONAL
2015-11-30
2017-03-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
NCT04779242
A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP
NCT06162286
Phase II Study of Oral Nafithromycin in CABP
NCT02903836
Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia
NCT01198626
A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia
NCT00717561
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Omadacycline
Omadacycline IV; Omadacycline tablets
Omadacycline
Injection for IV; Oral tablets
Moxifloxacin
Moxifloxacin IV; Moxifloxacin tablets
Moxifloxacin
IV solution; Oral tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Omadacycline
Injection for IV; Oral tablets
Moxifloxacin
IV solution; Oral tablets
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Paratek Pharmaceuticals Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site 514
Birmingham, Alabama, United States
Site 501
Mobile, Alabama, United States
Site 508
Laguna Hills, California, United States
Site 505
Ventura, California, United States
Site 513
Stamford, Connecticut, United States
Site 511
Zachary, Louisiana, United States
Site 503
Detroit, Michigan, United States
Site 520
Saint Paul, Minnesota, United States
Site 512
St Louis, Missouri, United States
Site 506
Buffalo, New York, United States
Site 509
Dayton, Ohio, United States
Site 516
Huntington, West Virginia, 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 392
T'bilisi, , Georgia
Site 390
Tbilisi, , Georgia
Site 391
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 City, , 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 City, , 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PTK0796-CABP-1200
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.