Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
- Conditions
- Community-Acquired InfectionsBacterial Pneumonia
- Interventions
- Registration Number
- NCT02531438
- Lead Sponsor
- Paratek Pharmaceuticals Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 774
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moxifloxacin Moxifloxacin Moxifloxacin IV; Moxifloxacin tablets Omadacycline Omadacycline Omadacycline IV; Omadacycline tablets
- Primary Outcome Measures
Name Time Method Number of Participants With Early Clinical Response Screening; 72 to 120 hours after the first dose of test article 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.
- Secondary Outcome Measures
Name Time Method 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 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.
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 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.
Trial Locations
- Locations (140)
Site 481
🇵🇪Lima, Peru
Site 411
🇨🇿Praha 10, Czechia
Site 303
🇧🇬Pernik, Bulgaria
Site 306
🇧🇬Sliven, Bulgaria
Site 390
🇬🇪Tbilisi, Georgia
Site 410
🇨🇿Praha 5, Czechia
Site 274
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Site 506
🇺🇸Buffalo, New York, United States
Site 508
🇺🇸Laguna Hills, California, United States
Site 512
🇺🇸Saint Louis, Missouri, United States
Site 505
🇺🇸Ventura, California, United States
Site 503
🇺🇸Detroit, Michigan, United States
Site 501
🇺🇸Mobile, Alabama, United States
Site 514
🇺🇸Birmingham, Alabama, United States
Site 321
🇱🇻Riga, Latvia
Site 520
🇺🇸Saint Paul, Minnesota, United States
Site 509
🇺🇸Dayton, Ohio, United States
Site 279
🇧🇷São José Do Rio Preto, São Paulo, Brazil
Site 207
🇬🇷Athens, Attika, Greece
Site 513
🇺🇸Stamford, Connecticut, United States
Site 220
🇧🇪Liege, Belgium
Site 393
🇬🇪Tbilisi, Georgia
Site 210
🇬🇷Athens, Greece
Site 412
🇨🇿Kyjov, Czechia
Site 414
🇨🇿Trebic, Czechia
Site 320
🇱🇻Riga, Latvia
Site 292
🇰🇷Seoul, Korea, Republic of
Site 294
🇰🇷Seoul, Korea, Republic of
Site 276
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Site 277
🇧🇷Passo Fundo, Rio Grande Do Sul, Brazil
Site 391
🇬🇪Tbilisi, Georgia
Site 212
🇭🇷Zadar, Croatia
Site 201
🇭🇷Zagreb, Croatia
Site 202
🇭🇷Zagreb, Croatia
Site 251
🇭🇷Zagreb, Croatia
Site 405
🇭🇷Zagreb, Croatia
Site 415
🇩🇪Heidelberg, Germany
Site 416
🇩🇪Jena, Germany
Site 417
🇩🇪Paderborn, Germany
Site 208
🇬🇷Thessaloniki, Greece
Site 310
🇭🇺Budapest, Hungary
Site 316
🇭🇺Miskolc, Hungary
Site 315
🇭🇺Szekesfehervar, Hungary
Site 213
🇮🇱Holon, Israel
Site 217
🇮🇱Petach-Tikwa, Israel
Site 214
🇮🇱Nazareth, Israel
Site 293
🇰🇷Daegu, Korea, Republic of
Site 291
🇰🇷Seoul, Korea, Republic of
Site 227
🇲🇽Monterrey, Nuevo Leon, Mexico
Site 230
🇲🇽Xalapa, Veracruz, Mexico
Site 234
🇵🇪Cusco, Peru
Site 236
🇵🇪Lima, Peru
Site 238
🇵🇪Lima, Peru
Site 239
🇵🇪Lima, Peru
Site 237
🇵🇪Trujillo, Peru
Site 555
🇵🇭Caloocan City, Philippines
554
🇵🇭Manila City, Philippines
Site 553
🇵🇭Quezon City, Philippines
Site 334
🇵🇱Leczna, Poland
Site 331
🇵🇱Wroclaw, Poland
Site 340
🇷🇴Bucharest, Romania
Site 342
🇷🇴Bucharest, Romania
Site 343
🇷🇴Bucharest, Romania
Site 345
🇷🇴Craiova, Romania
352
🇷🇺Moscow, Russian Federation
Site 350
🇷🇺Moscow, Russian Federation
Site 351
🇷🇺Moscow, Russian Federation
Site 353
🇷🇺Saint Petersburg, Russian Federation
Site 355
🇷🇺Saint Petersburg, Russian Federation
Site 359
🇷🇺Zelenograd, Russian Federation
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 225
🇪🇸Elche, Alicante, Spain
Site 221
🇪🇸Barcelona, Cataluña, Spain
Site 440
🇪🇸Barcelona, Cataluña, Spain
Site 224
🇪🇸Alcira, Valencia, Spain
Site 226
🇪🇸Alicante, Spain
Site 299
🇨🇳Kaohsiung, Taiwan
Site 297
🇨🇳Tainan, Taiwan
Site 295
🇨🇳Taipei, Taiwan
Site 296
🇨🇳Taipei, Taiwan
Site 247
🇹🇷Ankara, Turkey
Site 248
🇹🇷Ankara, Turkey
Site 249
🇹🇷Ankara, Turkey
Site 380
🇺🇦Dnipropetrovs'k, Ukraine
Site 246
🇹🇷Trabzon, Turkey
Site 370
🇺🇦Kyiv, Ukraine
Site 375
🇺🇦Kharkiv, Ukraine
Site 372
🇺🇦Kyiv, Ukraine
Site 378
🇺🇦Kyiv, Ukraine
Site 376
🇺🇦Zaporizhia, Ukraine
Site 301
🇧🇬Sofia, Bulgaria
Site 323
🇱🇻Liepaja, Latvia
Site 311
🇭🇺Budapest, Hungary
Site 304
🇧🇬Plovdiv, Bulgaria
Site 392
🇬🇪T'bilisi, Georgia
Site 516
🇺🇸Huntington, West Virginia, United States
Site 511
🇺🇸Zachary, Louisiana, United States
Site 302
🇧🇬Sofia, Bulgaria
Site 250
🇭🇷Požega, Croatia
Site 203
🇭🇷Zagreb, Croatia
Site 305
🇧🇬Kyustendil, Bulgaria
Site 307
🇧🇬Sofia, Bulgaria
Site 314
🇭🇺Debrecen, Hungary
Site 313
🇭🇺Nyíregyháza, Hungary
Site 205
🇭🇷Slavonski Brod, Croatia
Site 394
🇬🇪Tbilisi, Georgia
Site 228
🇲🇽Guadalajara, Jalisco, Mexico
Site 420
🇬🇷Athens, Attika, Greece
Site 215
🇮🇱Ramat-Gan, Israel
Site 312
🇭🇺Budapest, Hungary
Site 421
🇬🇷Athens, Greece
552
🇵🇭Iloilo City, Philippines
Site 333
🇵🇱Katowice, Poland
Site 330
🇵🇱Łódź, Poland
Site 216
🇮🇱Safed, Israel
Site 322
🇱🇻Daugavpils, Latvia
Site 471
🇲🇽Monterrey, Nuevo Leon, Mexico
Site 472
🇲🇽Guadalajara, Jalisco, Mexico
Site 233
🇵🇪Lima, Peru
Site 551
🇵🇭Quezon City, Philippines
Site 374
🇺🇦Kharkiv, Ukraine
Site 356
🇷🇺Saint Petersburg, Russian Federation
357
🇷🇺Sestroretsk, Russian Federation
Site 332
🇵🇱Chrzanow, Poland
Site 354
🇷🇺Saint Petersburg, Russian Federation
Site 341
🇷🇴Timisoara, Romania
Site 344
🇷🇴Brasov, Romania
Site 358
🇷🇺Vsevolozhsk, Russian Federation
Site 437
🇿🇦Somerset West, Western Cape, South Africa
Site 298
🇨🇳Taipei, Taiwan
Site 379
🇺🇦Kyiv, Ukraine
Site 373
🇺🇦Dnipropetrovsk, Ukraine