Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)

Bacterial Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531438
• Other study ID #: PTK0796-CABP-1200
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: March 10, 2017

Study information

• Verified date: January 2019
• Source: Paratek Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 774
• Est. completion date: March 10, 2017
• Est. primary completion date: February 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Pneumonia
• Community-Acquired Infections
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Omadacycline
Injection for IV; Oral tablets
• Moxifloxacin
IV solution; Oral tablets

Locations

Country	Name	City	State
Belgium	Site 220	Liege
Brazil	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
Bulgaria	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
Croatia	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
Czechia	Site 412	Kyjov
Czechia	Site 411	Praha 10
Czechia	Site 410	Praha 5
Czechia	Site 414	Trebic
Georgia	Site 392	T'bilisi
Georgia	Site 390	Tbilisi
Georgia	Site 391	Tbilisi
Georgia	Site 393	Tbilisi
Georgia	Site 394	Tbilisi
Germany	Site 415	Heidelberg
Germany	Site 416	Jena
Germany	Site 417	Paderborn
Greece	Site 207	Athens	Attika
Greece	Site 210	Athens
Greece	Site 420	Athens	Attika
Greece	Site 421	Athens
Greece	Site 208	Thessaloniki
Hungary	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
Israel	Site 213	Holon
Israel	Site 214	Nazareth
Israel	Site 217	Petach-Tikwa
Israel	Site 215	Ramat-Gan
Israel	Site 216	Safed
Korea, Republic of	Site 293	Daegu
Korea, Republic of	Site 291	Seoul
Korea, Republic of	Site 292	Seoul
Korea, Republic of	Site 294	Seoul
Latvia	Site 322	Daugavpils
Latvia	Site 323	Liepaja
Latvia	Site 320	Riga
Latvia	Site 321	Riga
Mexico	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
Peru	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
Philippines	Site 555	Caloocan City
Philippines	552	Iloilo City
Philippines	554	Manila City
Philippines	Site 551	Quezon City
Philippines	Site 553	Quezon City
Poland	Site 332	Chrzanow
Poland	Site 333	Katowice
Poland	Site 334	Leczna
Poland	Site 330	Lódz
Poland	Site 331	Wroclaw
Romania	Site 344	Brasov
Romania	Site 340	Bucharest
Romania	Site 342	Bucharest
Romania	Site 343	Bucharest
Romania	Site 345	Craiova
Romania	Site 341	Timisoara
Russian Federation	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
Slovakia	Site 431	Bratislava
Slovakia	Site 430	Levice
Slovakia	Site 432	Martin
Slovakia	Site 433	Nitra
South Africa	Site 241	Benoni	Gauteng
South Africa	Site 436	Centurion	Gauteng
South Africa	Site 245	Middelburg	Mpumalanga
South Africa	Site 242	Pretoria	Guateng
South Africa	Site 437	Somerset West	Western Cape
South Africa	Site 244	Thabazimbi	Limpopo
Spain	Site 224	Alcira	Valencia
Spain	Site 226	Alicante
Spain	Site 221	Barcelona	Cataluña
Spain	Site 440	Barcelona	Cataluña
Spain	Site 225	Elche	Alicante
Taiwan	Site 299	Kaohsiung
Taiwan	Site 297	Tainan
Taiwan	Site 295	Taipei
Taiwan	Site 296	Taipei
Taiwan	Site 298	Taipei
Turkey	Site 247	Ankara
Turkey	Site 248	Ankara
Turkey	Site 249	Ankara
Turkey	Site 246	Trabzon
Ukraine	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
United States	Site 514	Birmingham	Alabama
United States	Site 506	Buffalo	New York
United States	Site 509	Dayton	Ohio
United States	Site 503	Detroit	Michigan
United States	Site 516	Huntington	West Virginia
United States	Site 508	Laguna Hills	California
United States	Site 501	Mobile	Alabama
United States	Site 512	Saint Louis	Missouri
United States	Site 520	Saint Paul	Minnesota
United States	Site 513	Stamford	Connecticut
United States	Site 505	Ventura	California
United States	Site 511	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Paratek Pharmaceuticals Inc

Countries where clinical trial is conducted

United States,  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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Screening; 72 to 120 hours after the first dose of test article
Secondary	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.	Screening; 5 to 10 days after the last day of therapy
Secondary	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.	Screening; 5 to 10 days after the last day of therapy