Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

• ClinicalTrials.gov Identifier: NCT02877927
• Recruitment Status: Completed
• First Posted: August 24, 2016
• Results First Posted: November 30, 2018
• Last Update Posted: November 30, 2018
• Sponsor: Paratek Pharmaceuticals Inc
• Information provided by (Responsible Party): Paratek Pharmaceuticals Inc

Tracking Information

• First Submitted Date: August 15, 2016
• First Posted Date: August 24, 2016
• Results First Submitted Date: November 2, 2018
• Results First Posted Date: November 30, 2018
• Last Update Posted Date: November 30, 2018
• Study Start Date: August 2016
• Actual Primary Completion Date: May 26, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 28, 2018)

Number of Participants With Early Clinical Response [ Time Frame: 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.

Original Primary Outcome Measures (submitted: August 19, 2016)

• Clinical success at the early clinical response assessment visit defined as survival with a greater than or equal to 20% reduction of lesion size [ Time Frame: 48-72 hours ]
• Clinical success at the post treatment evaluation visit defined as survival after completion of a test article regimen, with resolution of improvement of signs and symptoms of infection [ Time Frame: 7-14 days after the last day of therapy ]
  Signs and Symptoms of infection include presence of drainage, tenderness, edema, erythema, and induration

Current Secondary Outcome Measures (submitted: November 28, 2018)

• Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit [ Time Frame: 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; infection was sufficiently resolved such that further antibacterial therapy was not needed. 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; other specified reason. Indeterminate The 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 [ Time Frame: 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; infection was sufficiently resolved such that further antibacterial therapy was not needed. 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; other specified reason.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI
• Official Title: A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Oral Omadacycline to Oral Linezolid for Treating Adult Subjects With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Bacterial Infections
• Skin Structures and Soft Tissue Infections

Intervention

• Drug: Omadacycline
  po tablets
• Drug: Linezolid
  po tablets
  Other Name: Zyvox

Study Arms

• Experimental: Omadacycline
  Omadacycline tablets
  Intervention: Drug: Omadacycline
• Active Comparator: Linezolid
  Linezolid tablets
  Intervention: Drug: Linezolid

Publications *

• 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.
• O'Riordan W, Cardenas C, Shin E, Sirbu A, Garrity-Ryan L, Das AF, Eckburg PB, Manley A, Steenbergen JN, Tzanis E, McGovern PC, Loh E; OASIS-2 Investigators. Once-daily oral omadacycline versus twice-daily oral linezolid for acute bacterial skin and skin structure infections (OASIS-2): a phase 3, double-blind, multicentre, randomised, controlled, non-inferiority trial. Lancet Infect Dis. 2019 Oct;19(10):1080-1090. doi: 10.1016/S1473-3099(19)30275-0. Epub 2019 Aug 29.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 13, 2017): 735
• Original Estimated Enrollment (submitted: August 19, 2016): 704
• Actual Study Completion Date: June 6, 2017
• Actual Primary Completion Date: May 26, 2017 (Final data collection date for primary outcome measure)

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 treatments and procedures, or that require antibacterial treatment for greater than 14 days
• Evidence of significant immunological disease
• Severe renal disease or requirement for dialysis
• Evidence of septic shock
• Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
• Has received an investigational drug within the past 30 days
• Women who are pregnant or nursing

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02877927
• Other Study ID Numbers: PTK0796-ABSI-16301
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Paratek Pharmaceuticals Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Paratek Pharmaceuticals Inc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Amy Manley; Senior Director, Clinical Operations

• PRS Account: Paratek Pharmaceuticals Inc
• Verification Date: November 2018