Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
- Conditions
- Skin Structures and Soft Tissue InfectionsBacterial Infections
- Interventions
- Registration Number
- NCT02378480
- Lead Sponsor
- Paratek Pharmaceuticals Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 655
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omadacycline Omadacycline Omadacycline IV; Omadacycline tablets Linezolid Linezolid Linezolid IV; Linezolid tablets
- Primary Outcome Measures
Name Time Method Number of Participants With Early Clinical Response Screening; 48 to 72 hours after the first dose of test article Early clinical response is defined as clinical success, which is categorized as survival with at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to Screening measurements, without receiving any rescue antibacterial therapy. An indeterminate classification is used for a response 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit Screening; 7 to 14 days after the last day of therapy At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the infection was sufficiently resolved such that further antibacterial therapy was not needed. These participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the End-of-Treatment (EOT) Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation. Indeterminate: 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 (CE-PTE) Population Screening; 7 to 14 days after the last day of therapy At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the infection was sufficiently resolved such that further antibacterial therapy was not needed. These participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the EOT Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation.
Number of Participants With the Indicated Type of Adverse Event (AE) 0 to 37 days An AE is defined as any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a test article or in a clinical study. The event does not need to be causally related to the test article or clinical study. A serious adverse event (SAE) is defined as an event that resulted in death, was life-threatening, required hospitalization or prolongation of an existing hospitalization, resulted in a persistent or significant disability or incapacity, resulted in cancer, or resulted in a congenital anomaly or birth defect. A treatment-emergent AE (TEAE) is defined as any AE that newly appeared, increased in frequency, or worsened in severity on or after the initiation of active test article. Vital sign measurements, electrocardiogram findings, and laboratory values classified as adverse events were included in the analysis. Data are presented as the number of participants with at least 1 of the event.
Trial Locations
- Locations (78)
Site 256
🇺🇸Augusta, Georgia, United States
Site 252
🇺🇸Santa Ana, California, United States
Site 259
🇺🇸Miami, Florida, United States
Site 171
🇺🇦Kyiv, Ukraine
Site 234
🇵🇪Cusco, Peru
Site 237
🇵🇪Trujillo, Peru
Site 266
🇺🇸Butte, Montana, United States
Site 141
🇷🇴Bucharest, Romania
Site 142
🇷🇴Bucharest, Romania
Site 144
🇷🇴Cluj-Napoca, Romania
Site 121
🇱🇻Riga, Latvia
Site 236
🇵🇪Lima, Peru
Site 146
🇷🇴Bucharest, Romania
Site 140
🇷🇴Craiova, Romania
Site 239
🇵🇪Lima, Peru
Site 260
🇺🇸Santa Ana, California, United States
Site 258
🇺🇸Oceanside, California, United States
Site 261
🇺🇸Mobile, Alabama, United States
Site 205
🇭🇷Slavonski Brod, Croatia
Site 201
🇭🇷Zagreb, Croatia
Site 253
🇺🇸Columbus, Georgia, United States
Site 209
🇬🇷Thessaloniki, Greece
Site 264
🇺🇸West Palm Beach, Florida, United States
Site 257
🇺🇸Springfield, Massachusetts, United States
Site 103
🇧🇬Rousse, Bulgaria
Site 202
🇭🇷Zagreb, Croatia
Site 124
🇱🇻Rezekne, Latvia
Site 120
🇱🇻Riga, Latvia
Site 233
🇵🇪Lima, Peru
Site 145
🇷🇴Timisoara, Romania
Site 143
🇷🇴Târgu-Mureş, Romania
Site 173
🇺🇦Dnipropetrovsk, Ukraine
Site 263
🇺🇸Las Vegas, Nevada, United States
Site 262
🇺🇸Chula Vista, California, United States
Site 204
🇭🇷Zagreb, Croatia
Site 254
🇺🇸La Mesa, California, United States
Site 269
🇺🇸Stockton, California, United States
Site 268
🇺🇸Detroit, Michigan, United States
Site 273
🇺🇸Buffalo, New York, United States
Site 255
🇺🇸Rapid City, South Dakota, United States
Site 270
🇺🇸Somers Point, New Jersey, United States
Site 102
🇧🇬Plovdiv, Bulgaria
Site 104
🇧🇬Pleven, Bulgaria
Site 105
🇧🇬Plovdiv, Bulgaria
Site 101
🇧🇬Sofia, Bulgaria
Site 203
🇭🇷Zagreb, Croatia
Site 207
🇬🇷Athens, Greece
Site 211
🇬🇷Athens, Greece
Site 110
🇭🇺Budapest, Hungary
Site 208
🇬🇷Thessaloniki, Greece
Site 111
🇭🇺Budapest, Hungary
Site 214
🇮🇱Nazareth, Israel
Site 114
🇭🇺Miskolc, Hungary
Site 113
🇭🇺Szeged, Hungary
Site 213
🇮🇱Holon, Israel
Site 216
🇮🇱Safed, Israel
Site 219
🇮🇱Kfar-Saba, Israel
Site 122
🇱🇻Daugavpils, Latvia
Site 123
🇱🇻Liepaja, Latvia
Site 238
🇵🇪Lima, Peru
Site 130
🇵🇱Bydgoszcz, Poland
Site 131
🇵🇱Lodz, Poland
Site 133
🇵🇱Katowice, Poland
Site 241
🇿🇦Benoni, Gauteng, South Africa
Site 221
🇪🇸Barcelona, Cataluna, Spain
Site 244
🇿🇦Thabazimbi, Limpopo, South Africa
Site 222
🇪🇸Terrassa, Barcelona, Spain
Site 247
🇹🇷Ankara, Turkey
Site 246
🇹🇷Trabzon, Turkey
Site 172
🇺🇦Dnipropetrovsk, Ukraine
Site 174
🇺🇦Odesa, Ukraine
Site 170
🇺🇦Lviv, Ukraine
Site 175
🇺🇦Uzhhorod, Ukraine
Site 176
🇺🇦Zaporizhia, Ukraine
Site 178
🇺🇦Vinnytsia, Ukraine
Site 132
🇵🇱Warszawa, Poland
Site 134
🇵🇱Olsztyn, Poland
Site 179
🇺🇦Kharkiv, Ukraine