Back to resultsOmadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
Primary Purpose
Bacterial Pneumonia, Community-Acquired Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Omadacycline
Moxifloxacin
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Site 514
- Site 501
- Site 508
- Site 505
- Site 513
- Site 511
- Site 503
- Site 520
- Site 512
- Site 506
- Site 509
- Site 516
- Site 220
- Site 276
- Site 277
- Site 274
- Site 279
- Site 305
- Site 303
- Site 304
- Site 306
- Site 301
- Site 302
- Site 307
- Site 250
- Site 205
- Site 212
- Site 201
- Site 202
- Site 203
- Site 251
- Site 405
- Site 412
- Site 411
- Site 410
- Site 414
- Site 392
- Site 390
- Site 391
- Site 393
- Site 394
- Site 415
- Site 416
- Site 417
- Site 207
- Site 420
- Site 210
- Site 421
- Site 208
- Site 310
- Site 311
- Site 312
- Site 314
- Site 316
- Site 313
- Site 315
- Site 213
- Site 214
- Site 217
- Site 215
- Site 216
- Site 293
- Site 291
- Site 292
- Site 294
- Site 322
- Site 323
- Site 320
- Site 321
- Site 228
- Site 472
- Site 227
- Site 471
- Site 230
- Site 234
- Site 233
- Site 236
- Site 238
- Site 239
- Site 481
- Site 237
- Site 555
- 552
- 554
- Site 551
- Site 553
- Site 332
- Site 333
- Site 334
- Site 331
- Site 330
- Site 344
- Site 340
- Site 342
- Site 343
- Site 345
- Site 341
- 352
- Site 350
- Site 351
- Site 353
- Site 354
- Site 355
- Site 356
- 357
- Site 358
- Site 359
- Site 431
- Site 430
- Site 432
- Site 433
- Site 241
- Site 436
- Site 242
- Site 244
- Site 245
- Site 437
- Site 225
- Site 221
- Site 440
- Site 224
- Site 226
- Site 299
- Site 297
- Site 295
- Site 296
- Site 298
- Site 247
- Site 248
- Site 249
- Site 246
- Site 380
- Site 373
- Site 374
- Site 375
- Site 370
- Site 372
- Site 378
- Site 379
- Site 376
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Omadacycline
Moxifloxacin
Arm Description
Omadacycline IV; Omadacycline tablets
Moxifloxacin IV; Moxifloxacin tablets
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the ITT Population at the Post Therapy Evaluation (PTE) Visit
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
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.
Full Information
NCT ID
NCT02531438
First Posted
July 14, 2015
Last Updated
January 3, 2019
Sponsor
Paratek Pharmaceuticals Inc
1. Study Identification
Unique Protocol Identification Number
NCT02531438
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
February 5, 2017 (Actual)
Study Completion Date
March 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Paratek Pharmaceuticals Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Pneumonia, Community-Acquired Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
774 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omadacycline
Arm Type
Experimental
Arm Description
Omadacycline IV; Omadacycline tablets
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
Moxifloxacin IV; Moxifloxacin tablets
Intervention Type
Drug
Intervention Name(s)
Omadacycline
Intervention Description
Injection for IV; Oral tablets
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
Avelox
Intervention Description
IV solution; Oral tablets
Primary Outcome Measure Information:
Title
Number of Participants With Early Clinical Response
Description
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.
Time Frame
Screening; 72 to 120 hours after the first dose of test article
Secondary Outcome Measure Information:
Title
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the ITT Population at the Post Therapy Evaluation (PTE) Visit
Description
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.
Time Frame
Screening; 5 to 10 days after the last day of therapy
Title
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CT-PTE) Population
Description
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.
Time Frame
Screening; 5 to 10 days after the last day of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Site 514
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Site 501
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Site 508
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Site 505
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Site 513
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Site 511
City
Zachary
State/Province
Louisiana
ZIP/Postal Code
70791
Country
United States
Facility Name
Site 503
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Site 520
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Site 512
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site 506
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Site 509
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Site 516
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Site 220
City
Liege
Country
Belgium
Facility Name
Site 276
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Site 277
City
Passo Fundo
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Site 274
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Site 279
City
São José Do Rio Preto
State/Province
São Paulo
Country
Brazil
Facility Name
Site 305
City
Kyustendil
Country
Bulgaria
Facility Name
Site 303
City
Pernik
Country
Bulgaria
Facility Name
Site 304
City
Plovdiv
Country
Bulgaria
Facility Name
Site 306
City
Sliven
Country
Bulgaria
Facility Name
Site 301
City
Sofia
Country
Bulgaria
Facility Name
Site 302
City
Sofia
Country
Bulgaria
Facility Name
Site 307
City
Sofia
Country
Bulgaria
Facility Name
Site 250
City
Požega
Country
Croatia
Facility Name
Site 205
City
Slavonski Brod
Country
Croatia
Facility Name
Site 212
City
Zadar
Country
Croatia
Facility Name
Site 201
City
Zagreb
Country
Croatia
Facility Name
Site 202
City
Zagreb
Country
Croatia
Facility Name
Site 203
City
Zagreb
Country
Croatia
Facility Name
Site 251
City
Zagreb
Country
Croatia
Facility Name
Site 405
City
Zagreb
Country
Croatia
Facility Name
Site 412
City
Kyjov
Country
Czechia
Facility Name
Site 411
City
Praha 10
Country
Czechia
Facility Name
Site 410
City
Praha 5
Country
Czechia
Facility Name
Site 414
City
Trebic
Country
Czechia
Facility Name
Site 392
City
T'bilisi
Country
Georgia
Facility Name
Site 390
City
Tbilisi
Country
Georgia
Facility Name
Site 391
City
Tbilisi
Country
Georgia
Facility Name
Site 393
City
Tbilisi
Country
Georgia
Facility Name
Site 394
City
Tbilisi
Country
Georgia
Facility Name
Site 415
City
Heidelberg
Country
Germany
Facility Name
Site 416
City
Jena
Country
Germany
Facility Name
Site 417
City
Paderborn
Country
Germany
Facility Name
Site 207
City
Athens
State/Province
Attika
Country
Greece
Facility Name
Site 420
City
Athens
State/Province
Attika
Country
Greece
Facility Name
Site 210
City
Athens
Country
Greece
Facility Name
Site 421
City
Athens
Country
Greece
Facility Name
Site 208
City
Thessaloniki
Country
Greece
Facility Name
Site 310
City
Budapest
Country
Hungary
Facility Name
Site 311
City
Budapest
Country
Hungary
Facility Name
Site 312
City
Budapest
Country
Hungary
Facility Name
Site 314
City
Debrecen
Country
Hungary
Facility Name
Site 316
City
Miskolc
Country
Hungary
Facility Name
Site 313
City
Nyíregyháza
Country
Hungary
Facility Name
Site 315
City
Szekesfehervar
Country
Hungary
Facility Name
Site 213
City
Holon
Country
Israel
Facility Name
Site 214
City
Nazareth
Country
Israel
Facility Name
Site 217
City
Petach-Tikwa
Country
Israel
Facility Name
Site 215
City
Ramat-Gan
Country
Israel
Facility Name
Site 216
City
Safed
Country
Israel
Facility Name
Site 293
City
Daegu
Country
Korea, Republic of
Facility Name
Site 291
City
Seoul
Country
Korea, Republic of
Facility Name
Site 292
City
Seoul
Country
Korea, Republic of
Facility Name
Site 294
City
Seoul
Country
Korea, Republic of
Facility Name
Site 322
City
Daugavpils
Country
Latvia
Facility Name
Site 323
City
Liepaja
Country
Latvia
Facility Name
Site 320
City
Riga
Country
Latvia
Facility Name
Site 321
City
Riga
Country
Latvia
Facility Name
Site 228
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Site 472
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Site 227
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Site 471
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Site 230
City
Xalapa
State/Province
Veracruz
Country
Mexico
Facility Name
Site 234
City
Cusco
Country
Peru
Facility Name
Site 233
City
Lima
Country
Peru
Facility Name
Site 236
City
Lima
Country
Peru
Facility Name
Site 238
City
Lima
Country
Peru
Facility Name
Site 239
City
Lima
Country
Peru
Facility Name
Site 481
City
Lima
Country
Peru
Facility Name
Site 237
City
Trujillo
Country
Peru
Facility Name
Site 555
City
Caloocan City
Country
Philippines
Facility Name
552
City
Iloilo City
Country
Philippines
Facility Name
554
City
Manila City
Country
Philippines
Facility Name
Site 551
City
Quezon City
Country
Philippines
Facility Name
Site 553
City
Quezon City
Country
Philippines
Facility Name
Site 332
City
Chrzanow
Country
Poland
Facility Name
Site 333
City
Katowice
Country
Poland
Facility Name
Site 334
City
Leczna
Country
Poland
Facility Name
Site 331
City
Wroclaw
Country
Poland
Facility Name
Site 330
City
Łódź
Country
Poland
Facility Name
Site 344
City
Brasov
Country
Romania
Facility Name
Site 340
City
Bucharest
Country
Romania
Facility Name
Site 342
City
Bucharest
Country
Romania
Facility Name
Site 343
City
Bucharest
Country
Romania
Facility Name
Site 345
City
Craiova
Country
Romania
Facility Name
Site 341
City
Timisoara
Country
Romania
Facility Name
352
City
Moscow
Country
Russian Federation
Facility Name
Site 350
City
Moscow
Country
Russian Federation
Facility Name
Site 351
City
Moscow
Country
Russian Federation
Facility Name
Site 353
City
Saint Petersburg
Country
Russian Federation
Facility Name
Site 354
City
Saint Petersburg
Country
Russian Federation
Facility Name
Site 355
City
Saint Petersburg
Country
Russian Federation
Facility Name
Site 356
City
Saint Petersburg
Country
Russian Federation
Facility Name
357
City
Sestroretsk
Country
Russian Federation
Facility Name
Site 358
City
Vsevolozhsk
Country
Russian Federation
Facility Name
Site 359
City
Zelenograd
Country
Russian Federation
Facility Name
Site 431
City
Bratislava
Country
Slovakia
Facility Name
Site 430
City
Levice
Country
Slovakia
Facility Name
Site 432
City
Martin
Country
Slovakia
Facility Name
Site 433
City
Nitra
Country
Slovakia
Facility Name
Site 241
City
Benoni
State/Province
Gauteng
Country
South Africa
Facility Name
Site 436
City
Centurion
State/Province
Gauteng
Country
South Africa
Facility Name
Site 242
City
Pretoria
State/Province
Guateng
Country
South Africa
Facility Name
Site 244
City
Thabazimbi
State/Province
Limpopo
Country
South Africa
Facility Name
Site 245
City
Middelburg
State/Province
Mpumalanga
Country
South Africa
Facility Name
Site 437
City
Somerset West
State/Province
Western Cape
Country
South Africa
Facility Name
Site 225
City
Elche
State/Province
Alicante
Country
Spain
Facility Name
Site 221
City
Barcelona
State/Province
Cataluña
Country
Spain
Facility Name
Site 440
City
Barcelona
State/Province
Cataluña
Country
Spain
Facility Name
Site 224
City
Alcira
State/Province
Valencia
Country
Spain
Facility Name
Site 226
City
Alicante
Country
Spain
Facility Name
Site 299
City
Kaohsiung
Country
Taiwan
Facility Name
Site 297
City
Tainan
Country
Taiwan
Facility Name
Site 295
City
Taipei
Country
Taiwan
Facility Name
Site 296
City
Taipei
Country
Taiwan
Facility Name
Site 298
City
Taipei
Country
Taiwan
Facility Name
Site 247
City
Ankara
Country
Turkey
Facility Name
Site 248
City
Ankara
Country
Turkey
Facility Name
Site 249
City
Ankara
Country
Turkey
Facility Name
Site 246
City
Trabzon
Country
Turkey
Facility Name
Site 380
City
Dnipropetrovs'k
Country
Ukraine
Facility Name
Site 373
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Site 374
City
Kharkiv
Country
Ukraine
Facility Name
Site 375
City
Kharkiv
Country
Ukraine
Facility Name
Site 370
City
Kyiv
Country
Ukraine
Facility Name
Site 372
City
Kyiv
Country
Ukraine
Facility Name
Site 378
City
Kyiv
Country
Ukraine
Facility Name
Site 379
City
Kyiv
Country
Ukraine
Facility Name
Site 376
City
Zaporizhia
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
35776862
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.
Results Reference
derived
PubMed Identifier
33326848
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.
Results Reference
derived
PubMed Identifier
31367741
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.
Results Reference
derived
PubMed Identifier
30726692
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.
Results Reference
derived
Learn more about this trial
Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
We'll reach out to this number within 24 hrs