Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
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)
1 other identifier
interventional
655
14 countries
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2015
Shorter than P25 for phase_3
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
March 21, 2019
CompletedMarch 21, 2019
March 1, 2019
10 months
February 19, 2015
January 9, 2019
March 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Early Clinical Response
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.
Screening; 48 to 72 hours after the first dose of test article
Secondary Outcomes (3)
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
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
Number of Participants With the Indicated Type of Adverse Event (AE)
0 to 37 days
Study Arms (2)
Omadacycline
EXPERIMENTALOmadacycline IV; Omadacycline tablets
Linezolid
ACTIVE COMPARATORLinezolid IV; Linezolid tablets
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Site 261
Mobile, Alabama, 36608, United States
Site 262
Chula Vista, California, 91911, United States
Site 254
La Mesa, California, 91942, United States
Site 258
Oceanside, California, 92056, United States
Site 252
Santa Ana, California, 92705, United States
Site 260
Santa Ana, California, 92705, United States
Site 269
Stockton, California, 95204, United States
Site 259
Miami, Florida, 33144, United States
Site 264
West Palm Beach, Florida, 33407, United States
Site 256
Augusta, Georgia, 30909, United States
Site 253
Columbus, Georgia, 31904, United States
Site 257
Springfield, Massachusetts, 01199, United States
Site 268
Detroit, Michigan, 48202, United States
Site 266
Butte, Montana, 59701, United States
Site 263
Las Vegas, Nevada, 89119, United States
Site 270
Somers Point, New Jersey, 08244, United States
Site 273
Buffalo, New York, 14215, United States
Site 255
Rapid City, South Dakota, 57702, 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, 10000, Croatia
Site 203
Zagreb, 10000, 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
Related Publications (6)
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.
PMID: 39461915DERIVEDVacalis 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.
PMID: 35776862DERIVEDPai 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.
PMID: 33458763DERIVEDCornely 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.
PMID: 33326848DERIVEDAbrahamian 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.
PMID: 31367742DERIVEDO'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.
PMID: 30726689DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Paul McGovern; Vice President, Clinical Affairs
- Organization
- Paratek Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2015
First Posted
March 4, 2015
Study Start
June 1, 2015
Primary Completion
April 1, 2016
Study Completion
May 1, 2016
Last Updated
March 21, 2019
Results First Posted
March 21, 2019
Record last verified: 2019-03