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

Sponsors

Lead Sponsor: Paratek Pharmaceuticals Inc

Source 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.

Overall Status Completed
Start Date 2015-11-01
Completion Date 2017-03-10
Primary Completion Date 2017-02-05
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants With Early Clinical Response Screening; 72 to 120 hours after the first dose of test article
Secondary Outcome
Measure Time Frame
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
Enrollment 774
Condition
Intervention

Intervention Type: Drug

Intervention Name: Omadacycline

Description: Injection for IV; Oral tablets

Arm Group Label: Omadacycline

Intervention Type: Drug

Intervention Name: Moxifloxacin

Description: IV solution; Oral tablets

Arm Group Label: Moxifloxacin

Other Name: Avelox

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Location
Facility:
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 | Saint 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 | Liege, 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 411 | Praha 10, Czechia
Site 410 | Praha 5, Czechia
Site 414 | Trebic, 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, Attika, Greece
Site 420 | Athens, Attika, 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 | Szekesfehervar, Hungary
Site 213 | Holon, Israel
Site 214 | Nazareth, Israel
Site 217 | Petach-Tikwa, Israel
Site 215 | Ramat-Gan, Israel
Site 216 | Safed, Israel
Site 293 | Daegu, Korea, Republic of
Site 291 | Seoul, Korea, Republic of
Site 292 | Seoul, Korea, Republic of
Site 294 | Seoul, Korea, Republic of
Site 322 | Daugavpils, Latvia
Site 323 | Liepaja, Latvia
Site 320 | Riga, Latvia
Site 321 | Riga, Latvia
Site 228 | Guadalajara, Jalisco, Mexico
Site 472 | Guadalajara, Jalisco, Mexico
Site 227 | Monterrey, Nuevo Leon, Mexico
Site 471 | Monterrey, Nuevo Leon, 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 City, Philippines
Site 551 | Quezon City, Philippines
Site 553 | Quezon City, Philippines
Site 332 | Chrzanow, Poland
Site 333 | Katowice, Poland
Site 334 | Leczna, Poland
Site 331 | Wroclaw, Poland
Site 330 | Łódź, Poland
Site 344 | Brasov, Romania
Site 340 | Bucharest, Romania
Site 342 | Bucharest, Romania
Site 343 | Bucharest, Romania
Site 345 | Craiova, Romania
Site 341 | Timisoara, Romania
352 | Moscow, Russian Federation
Site 350 | Moscow, Russian Federation
Site 351 | Moscow, Russian Federation
Site 353 | Saint Petersburg, Russian Federation
Site 354 | Saint Petersburg, Russian Federation
Site 355 | Saint Petersburg, Russian Federation
Site 356 | Saint Petersburg, Russian Federation
357 | Sestroretsk, Russian Federation
Site 358 | Vsevolozhsk, 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 437 | Somerset West, Western Cape, 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 298 | Taipei, Taiwan
Site 247 | Ankara, Turkey
Site 248 | Ankara, Turkey
Site 249 | Ankara, Turkey
Site 246 | Trabzon, Turkey
Site 380 | Dnipropetrovs'k, 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
Location Countries

Belgium

Brazil

Bulgaria

Croatia

Czechia

Georgia

Germany

Greece

Hungary

Israel

Korea, Republic of

Latvia

Mexico

Peru

Philippines

Poland

Romania

Russian Federation

Slovakia

South Africa

Spain

Taiwan

Turkey

Ukraine

United States

Verification Date

2019-01-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Omadacycline

Type: Experimental

Description: Omadacycline IV; Omadacycline tablets

Label: Moxifloxacin

Type: Active Comparator

Description: Moxifloxacin IV; Moxifloxacin tablets

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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