Clinical trial NCT02378480: Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
Official title: A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infections
Skin Structures and Soft Tissue Infections
Lead sponsor: Paratek Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2015-03-04
Enrollment: 655
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 linezolid in the treatment of adults with acute bacterial skin and skin structure infections.


Eligibility criteria: Inclusion Criteria:

* Patients, ages 18 years or older who have signed the informed consent
* Has a qualifying skin and skin structure infection
* 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:

* Infections where the outcome is strongly influenced by factors other than protocol-defined treatment and procedures, that require antibacterial treatment for greater than 14 days
* Evidence of significant immunological disease
* Severe sepsis or septic shock
* Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
* 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; 48 to 72 hours after the first dose of test article
Secondary outcomes:
measure: Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit
timeFrame: Screening; 7 to 14 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 (CE-PTE) Population
timeFrame: Screening; 7 to 14 days after the last day of therapy
measure: Number of Participants With the Indicated Type of Adverse Event (AE)
timeFrame: 0 to 37 days
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Site 261
state: Alabama
city: Chula Vista
country: United States
facility: Site 262
state: California
city: La Mesa
country: United States
facility: Site 254
state: California
city: Oceanside
country: United States
facility: Site 258
state: California
city: Santa Ana
country: United States
facility: Site 252
state: California
city: Santa Ana
country: United States
facility: Site 260
state: California
city: Stockton
country: United States
facility: Site 269
state: California
city: Miami
country: United States
facility: Site 259
state: Florida
city: West Palm Beach
country: United States
facility: Site 264
state: Florida
city: Augusta
country: United States
facility: Site 256
state: Georgia
city: Columbus
country: United States
facility: Site 253
state: Georgia
city: Springfield
country: United States
facility: Site 257
state: Massachusetts
city: Detroit
country: United States
facility: Site 268
state: Michigan
city: Butte
country: United States
facility: Site 266
state: Montana
city: Las Vegas
country: United States
facility: Site 263
state: Nevada
city: Somers Point
country: United States
facility: Site 270
state: New Jersey
city: Buffalo
country: United States
facility: Site 273
state: New York
city: Rapid City
country: United States
facility: Site 255
state: South Dakota
city: Pleven
country: Bulgaria
facility: Site 104
city: Plovdiv
country: Bulgaria
facility: Site 102
city: Plovdiv
country: Bulgaria
facility: Site 105
city: Rousse
country: Bulgaria
facility: Site 103
city: Sofia
country: Bulgaria
facility: Site 101
city: Slavonski Brod
country: Croatia
facility: Site 205
city: Zagreb
country: Croatia
facility: Site 201
city: Zagreb
country: Croatia
facility: Site 203
city: Zagreb
country: Croatia
facility: Site 202
city: Zagreb
country: Croatia
facility: Site 204
city: Athens
country: Greece
facility: Site 207
city: Athens
country: Greece
facility: Site 211
city: Thessaloniki
country: Greece
facility: Site 208
city: Thessaloniki
country: Greece
facility: Site 209
city: Budapest
country: Hungary
facility: Site 110
city: Budapest
country: Hungary
facility: Site 111
city: Miskolc
country: Hungary
facility: Site 114
city: Szeged
country: Hungary
facility: Site 113
city: Holon
country: Israel
facility: Site 213
city: Kfar-Saba
country: Israel
facility: Site 219
city: Nazareth
country: Israel
facility: Site 214
city: Safed
country: Israel
facility: Site 216
city: Daugavpils
country: Latvia
facility: Site 122
city: Liepaja
country: Latvia
facility: Site 123
city: Rezekne
country: Latvia
facility: Site 124
city: Riga
country: Latvia
facility: Site 120
city: Riga
country: Latvia
facility: Site 121
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: Trujillo
country: Peru
facility: Site 237
city: Bydgoszcz
country: Poland
facility: Site 130
city: Katowice
country: Poland
facility: Site 133
city: Lodz
country: Poland
facility: Site 131
city: Olsztyn
country: Poland
facility: Site 134
city: Warszawa
country: Poland
facility: Site 132
city: Bucharest
country: Romania
facility: Site 141
city: Bucharest
country: Romania
facility: Site 142
city: Bucharest
country: Romania
facility: Site 146
city: Cluj-Napoca
country: Romania
facility: Site 144
city: Craiova
country: Romania
facility: Site 140
city: Timisoara
country: Romania
facility: Site 145
city: Târgu-Mureş
country: Romania
facility: Site 143
city: Benoni
country: South Africa
facility: Site 241
state: Gauteng
city: Thabazimbi
country: South Africa
facility: Site 244
state: Limpopo
city: Terrassa
country: Spain
facility: Site 222
state: Barcelona
city: Barcelona
country: Spain
facility: Site 221
state: Cataluna
city: Ankara
country: Turkey
facility: Site 247
city: Trabzon
country: Turkey
facility: Site 246
city: Dnipropetrovsk
country: Ukraine
facility: Site 172
city: Dnipropetrovsk
country: Ukraine
facility: Site 173
city: Kharkiv
country: Ukraine
facility: Site 179
city: Kyiv
country: Ukraine
facility: Site 171
city: Lviv
country: Ukraine
facility: Site 170
city: Odesa
country: Ukraine
facility: Site 174
city: Uzhhorod
country: Ukraine
facility: Site 175
city: Vinnytsia
country: Ukraine
facility: Site 178
city: Zaporizhia
country: Ukraine
facility: Site 176
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: Pai MP, Wilcox MH, Chitra S, McGovern PC. Safety and efficacy of omadacycline by BMI categories and diabetes history in two Phase III randomized studies of patients with acute bacterial skin and skin structure infections. J Antimicrob Chemother. 2021 Apr 13;76(5):1315-1322. doi: 10.1093/jac/dkaa558.
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: Abrahamian FM, Sakoulas G, Tzanis E, Manley A, Steenbergen J, Das AF, Eckburg PB, McGovern PC. Omadacycline for Acute Bacterial Skin and Skin Structure Infections. Clin Infect Dis. 2019 Aug 1;69(Suppl 1):S23-S32. doi: 10.1093/cid/ciz396.
citation: O'Riordan W, Green S, Overcash JS, Puljiz I, Metallidis S, Gardovskis J, Garrity-Ryan L, Das AF, Tzanis E, Eckburg PB, Manley A, Villano SA, Steenbergen JN, Loh E. Omadacycline for Acute Bacterial Skin and Skin-Structure Infections. N Engl J Med. 2019 Feb 7;380(6):528-538. doi: 10.1056/NEJMoa1800170.