Clinical trial NCT02531438: Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Pneumonia
Community-Acquired Infections
Lead sponsor: Paratek Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2015-08-24
Enrollment: 774
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Early Clinical Response
timeFrame: Screening; 72 to 120 hours after the first dose of test article
Secondary outcomes:
measure: Number of Participants With the Indicated Investigator Assessment of Clinical Response in the ITT Population at the Post Therapy Evaluation (PTE) Visit
timeFrame: Screening; 5 to 10 days after the last day of therapy
measure: Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CT-PTE) Population
timeFrame: Screening; 5 to 10 days after the last day of therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 514
state: Alabama
city: Mobile
country: United States
facility: Site 501
state: Alabama
city: Laguna Hills
country: United States
facility: Site 508
state: California
city: Ventura
country: United States
facility: Site 505
state: California
city: Stamford
country: United States
facility: Site 513
state: Connecticut
city: Zachary
country: United States
facility: Site 511
state: Louisiana
city: Detroit
country: United States
facility: Site 503
state: Michigan
city: Saint Paul
country: United States
facility: Site 520
state: Minnesota
city: Saint Louis
country: United States
facility: Site 512
state: Missouri
city: Buffalo
country: United States
facility: Site 506
state: New York
city: Dayton
country: United States
facility: Site 509
state: Ohio
city: Huntington
country: United States
facility: Site 516
state: West Virginia
city: Liege
country: Belgium
facility: Site 220
city: Belo Horizonte
country: Brazil
facility: Site 276
state: Minas Gerais
city: Passo Fundo
country: Brazil
facility: Site 277
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Site 274
state: Rio Grande Do Sul
city: São José Do Rio Preto
country: Brazil
facility: Site 279
state: São Paulo
city: Kyustendil
country: Bulgaria
facility: Site 305
city: Pernik
country: Bulgaria
facility: Site 303
city: Plovdiv
country: Bulgaria
facility: Site 304
city: Sliven
country: Bulgaria
facility: Site 306
city: Sofia
country: Bulgaria
facility: Site 301
city: Sofia
country: Bulgaria
facility: Site 302
city: Sofia
country: Bulgaria
facility: Site 307
city: Požega
country: Croatia
facility: Site 250
city: Slavonski Brod
country: Croatia
facility: Site 205
city: Zadar
country: Croatia
facility: Site 212
city: Zagreb
country: Croatia
facility: Site 201
city: Zagreb
country: Croatia
facility: Site 202
city: Zagreb
country: Croatia
facility: Site 203
city: Zagreb
country: Croatia
facility: Site 251
city: Zagreb
country: Croatia
facility: Site 405
city: Kyjov
country: Czechia
facility: Site 412
city: Praha 10
country: Czechia
facility: Site 411
city: Praha 5
country: Czechia
facility: Site 410
city: Trebic
country: Czechia
facility: Site 414
city: T'bilisi
country: Georgia
facility: Site 392
city: Tbilisi
country: Georgia
facility: Site 390
city: Tbilisi
country: Georgia
facility: Site 391
city: Tbilisi
country: Georgia
facility: Site 393
city: Tbilisi
country: Georgia
facility: Site 394
city: Heidelberg
country: Germany
facility: Site 415
city: Jena
country: Germany
facility: Site 416
city: Paderborn
country: Germany
facility: Site 417
city: Athens
country: Greece
facility: Site 207
state: Attika
city: Athens
country: Greece
facility: Site 420
state: Attika
city: Athens
country: Greece
facility: Site 210
city: Athens
country: Greece
facility: Site 421
city: Thessaloniki
country: Greece
facility: Site 208
city: Budapest
country: Hungary
facility: Site 310
city: Budapest
country: Hungary
facility: Site 311
city: Budapest
country: Hungary
facility: Site 312
city: Debrecen
country: Hungary
facility: Site 314
city: Miskolc
country: Hungary
facility: Site 316
city: Nyíregyháza
country: Hungary
facility: Site 313
city: Szekesfehervar
country: Hungary
facility: Site 315
city: Holon
country: Israel
facility: Site 213
city: Nazareth
country: Israel
facility: Site 214
city: Petach-Tikwa
country: Israel
facility: Site 217
city: Ramat-Gan
country: Israel
facility: Site 215
city: Safed
country: Israel
facility: Site 216
city: Daegu
country: Korea, Republic of
facility: Site 293
city: Seoul
country: Korea, Republic of
facility: Site 291
city: Seoul
country: Korea, Republic of
facility: Site 292
city: Seoul
country: Korea, Republic of
facility: Site 294
city: Daugavpils
country: Latvia
facility: Site 322
city: Liepaja
country: Latvia
facility: Site 323
city: Riga
country: Latvia
facility: Site 320
city: Riga
country: Latvia
facility: Site 321
city: Guadalajara
country: Mexico
facility: Site 228
state: Jalisco
city: Guadalajara
country: Mexico
facility: Site 472
state: Jalisco
city: Monterrey
country: Mexico
facility: Site 227
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Site 471
state: Nuevo Leon
city: Xalapa
country: Mexico
facility: Site 230
state: Veracruz
city: Cusco
country: Peru
facility: Site 234
city: Lima
country: Peru
facility: Site 233
city: Lima
country: Peru
facility: Site 236
city: Lima
country: Peru
facility: Site 238
city: Lima
country: Peru
facility: Site 239
city: Lima
country: Peru
facility: Site 481
city: Trujillo
country: Peru
facility: Site 237
city: Caloocan City
country: Philippines
facility: Site 555
city: Iloilo City
country: Philippines
facility: 552
city: Manila City
country: Philippines
facility: 554
city: Quezon City
country: Philippines
facility: Site 551
city: Quezon City
country: Philippines
facility: Site 553
city: Chrzanow
country: Poland
facility: Site 332
city: Katowice
country: Poland
facility: Site 333
city: Leczna
country: Poland
facility: Site 334
city: Wroclaw
country: Poland
facility: Site 331
city: Łódź
country: Poland
facility: Site 330
city: Brasov
country: Romania
facility: Site 344
city: Bucharest
country: Romania
facility: Site 340
city: Bucharest
country: Romania
facility: Site 342
city: Bucharest
country: Romania
facility: Site 343
city: Craiova
country: Romania
facility: Site 345
city: Timisoara
country: Romania
facility: Site 341
city: Moscow
country: Russian Federation
facility: 352
city: Moscow
country: Russian Federation
facility: Site 350
city: Moscow
country: Russian Federation
facility: Site 351
city: Saint Petersburg
country: Russian Federation
facility: Site 353
city: Saint Petersburg
country: Russian Federation
facility: Site 354
city: Saint Petersburg
country: Russian Federation
facility: Site 355
city: Saint Petersburg
country: Russian Federation
facility: Site 356
city: Sestroretsk
country: Russian Federation
facility: 357
city: Vsevolozhsk
country: Russian Federation
facility: Site 358
city: Zelenograd
country: Russian Federation
facility: Site 359
city: Bratislava
country: Slovakia
facility: Site 431
city: Levice
country: Slovakia
facility: Site 430
city: Martin
country: Slovakia
facility: Site 432
city: Nitra
country: Slovakia
facility: Site 433
city: Benoni
country: South Africa
facility: Site 241
state: Gauteng
city: Centurion
country: South Africa
facility: Site 436
state: Gauteng
city: Pretoria
country: South Africa
facility: Site 242
state: Guateng
city: Thabazimbi
country: South Africa
facility: Site 244
state: Limpopo
city: Middelburg
country: South Africa
facility: Site 245
state: Mpumalanga
city: Somerset West
country: South Africa
facility: Site 437
state: Western Cape
city: Elche
country: Spain
facility: Site 225
state: Alicante
city: Barcelona
country: Spain
facility: Site 221
state: Cataluña
city: Barcelona
country: Spain
facility: Site 440
state: Cataluña
city: Alcira
country: Spain
facility: Site 224
state: Valencia
city: Alicante
country: Spain
facility: Site 226
city: Kaohsiung
country: Taiwan
facility: Site 299
city: Tainan
country: Taiwan
facility: Site 297
city: Taipei
country: Taiwan
facility: Site 295
city: Taipei
country: Taiwan
facility: Site 296
city: Taipei
country: Taiwan
facility: Site 298
city: Ankara
country: Turkey
facility: Site 247
city: Ankara
country: Turkey
facility: Site 248
city: Ankara
country: Turkey
facility: Site 249
city: Trabzon
country: Turkey
facility: Site 246
city: Dnipropetrovs'k
country: Ukraine
facility: Site 380
city: Dnipropetrovsk
country: Ukraine
facility: Site 373
city: Kharkiv
country: Ukraine
facility: Site 374
city: Kharkiv
country: Ukraine
facility: Site 375
city: Kyiv
country: Ukraine
facility: Site 370
city: Kyiv
country: Ukraine
facility: Site 372
city: Kyiv
country: Ukraine
facility: Site 378
city: Kyiv
country: Ukraine
facility: Site 379
city: Zaporizhia
country: Ukraine
facility: Site 376
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.