Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
NCT ID: NCT02378480
Last Updated: 2019-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
655 participants
INTERVENTIONAL
2015-06-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Omadacycline
Omadacycline IV; Omadacycline tablets
Omadacycline
Injection for IV dosing; Tablets for oral dosing
Linezolid
Linezolid IV; Linezolid tablets
Linezolid
Infusion solution for IV dosing; Tablets for oral dosing
Interventions
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Omadacycline
Injection for IV dosing; Tablets for oral dosing
Linezolid
Infusion solution for IV dosing; Tablets for oral dosing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Paratek Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Locations
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Site 261
Mobile, Alabama, United States
Site 262
Chula Vista, California, United States
Site 254
La Mesa, California, United States
Site 258
Oceanside, California, United States
Site 252
Santa Ana, California, United States
Site 260
Santa Ana, California, United States
Site 269
Stockton, California, United States
Site 259
Miami, Florida, United States
Site 264
West Palm Beach, Florida, United States
Site 256
Augusta, Georgia, United States
Site 253
Columbus, Georgia, United States
Site 257
Springfield, Massachusetts, United States
Site 268
Detroit, Michigan, United States
Site 266
Butte, Montana, United States
Site 263
Las Vegas, Nevada, United States
Site 270
Somers Point, New Jersey, United States
Site 273
Buffalo, New York, United States
Site 255
Rapid City, South Dakota, United States
Site 104
Pleven, , Bulgaria
Site 102
Plovdiv, , Bulgaria
Site 105
Plovdiv, , Bulgaria
Site 103
Rousse, , Bulgaria
Site 101
Sofia, , Bulgaria
Site 205
Slavonski Brod, , Croatia
Site 201
Zagreb, , Croatia
Site 203
Zagreb, , Croatia
Site 202
Zagreb, , Croatia
Site 204
Zagreb, , Croatia
Site 207
Athens, , Greece
Site 211
Athens, , Greece
Site 208
Thessaloniki, , Greece
Site 209
Thessaloniki, , Greece
Site 110
Budapest, , Hungary
Site 111
Budapest, , Hungary
Site 114
Miskolc, , Hungary
Site 113
Szeged, , Hungary
Site 213
Holon, , Israel
Site 219
Kfar Saba, , Israel
Site 214
Nazareth, , Israel
Site 216
Safed, , Israel
Site 122
Daugavpils, , Latvia
Site 123
Liepāja, , Latvia
Site 124
Rēzekne, , Latvia
Site 120
Riga, , Latvia
Site 121
Riga, , Latvia
Site 234
Cusco, , Peru
Site 233
Lima, , Peru
Site 236
Lima, , Peru
Site 238
Lima, , Peru
Site 239
Lima, , Peru
Site 237
Trujillo, , Peru
Site 130
Bydgoszcz, , Poland
Site 133
Katowice, , Poland
Site 131
Lodz, , Poland
Site 134
Olsztyn, , Poland
Site 132
Warsaw, , Poland
Site 141
Bucharest, , Romania
Site 142
Bucharest, , Romania
Site 146
Bucharest, , Romania
Site 144
Cluj-Napoca, , Romania
Site 140
Craiova, , Romania
Site 143
Târgu Mureş, , Romania
Site 145
Timișoara, , Romania
Site 241
Benoni, Gauteng, South Africa
Site 244
Thabazimbi, Limpopo, South Africa
Site 222
Terrassa, Barcelona, Spain
Site 221
Barcelona, Catalonia, Spain
Site 247
Ankara, , Turkey (Türkiye)
Site 246
Trabzon, , Turkey (Türkiye)
Site 172
Dnipropetrovsk, , Ukraine
Site 173
Dnipropetrovsk, , Ukraine
Site 179
Kharkiv, , Ukraine
Site 171
Kyiv, , Ukraine
Site 170
Lviv, , Ukraine
Site 174
Odesa, , Ukraine
Site 175
Uzhhorod, , Ukraine
Site 178
Vinnytsia, , Ukraine
Site 176
Zaporizhia, , Ukraine
Countries
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References
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Rodriguez GD, Warren N, Yashayev R, Chitra S, Amodio-Groton M, Wright K. Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials. Infect Dis Ther. 2024 Dec;13(12):2637-2648. doi: 10.1007/s40121-024-01057-3. Epub 2024 Oct 26.
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.
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.
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.
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.
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.
Other Identifiers
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PTK0796-ABSI-1108
Identifier Type: -
Identifier Source: org_study_id
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