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Bacterial InfectionsPhase 3NCT02877927

Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

A Phase 3 study testing Omadacycline and Linezolid in people with Bacterial Infections and Skin Structures and Soft Tissue Infections, run by Paratek Pharmaceuticals Inc at 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Omadacycline and Linezolid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
735 participants
Where
50 sitesUnited States
Study dates
Aug 2016to 6 Jun 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Site 616

    Anaheim, California, 92801

  • Site 601

    Anaheim, California, 92804

  • Site 636

    Bakersfield, California, 93301

  • Site 633

    Baytown, Texas, 77521

  • Site 620

    Birmingham, Alabama, 35215

  • Site 657

    Boston, Massachusetts, 02115

  • Site 606

    Buena Park, California, 90620

  • Site 602

    Butte, Montana, 59701

  • Site 605

    Channelview, Texas, 77530

  • Site 604

    Chula Vista, California, 91911

  • Site 644

    Council Bluffs, Iowa, 51503

  • Site 614

    DeLand, Florida, 32720

  • Site 655

    Fort Myers, Florida, 33901

  • Site 656

    Homestead, Florida, 33030

  • Site 625

    Houston, Texas, 77008

  • Site 627

    Houston, Texas, 77084

  • Site 659

    Huntington Beach, California, 92647

  • Site 635

    Jackson, Tennessee, 38305

  • Site 647

    Jackson Heights, New York, 11372

  • Site 608

    La Mesa, California, 91942

  • Site 618

    Laguna Hills, California, 92653

  • Site 623

    Las Vegas, Nevada, 89109

  • Site 612

    Long Beach, California, 90813

  • Site 631

    Miami, Florida, 33015

  • Site 658

    Miami, Florida, 33125

  • Site 654

    Miami, Florida, 33134

  • Site 626

    Miami, Florida, 33144

  • Site 637

    Miami, Florida, 33144

  • Site 653

    Miami, Florida, 33145

  • Site 641

    Miami, Florida, 33175

  • Site 645

    Miami, Florida, 33175

  • Site 640

    Miami Lakes, Florida, 33016

  • Site 662

    Miami Lakes, Florida, 33104

  • Site 642

    Mobile, Alabama, 36608

  • Site 648

    Modesto, California, 95350

  • Site 632

    Mount Airy, North Carolina, 27030

  • Site 610

    Oceanside, California, 92056

  • Site 607

    Rapid City, South Dakota, 57702

  • Site 609

    Saint Cloud, Florida, 34769

  • Site 615

    San Diego, California, 92114

  • Site 621

    San Diego, California, 92119

  • Site 613

    San Francisco, California, 94115

  • Site 628

    Smyrna, Tennessee, 37167

  • Site 630

    Somers Point, New Jersey, 08244

  • Site 617

    St Louis, Missouri, 63128

  • Site 603

    Stockton, California, 95204

  • Site 634

    Sugar Land, Texas, 77479

  • Site 649

    Toledo, Ohio, 43608

  • Site 650

    Torrance, California, 90502

  • Site 646

    Ventura, California, 93003

Other trials in United States

About this study

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)

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.

Being tested
Omadacycline, Linezolid
Medical subject headings
Bacterial Infections, Soft Tissue Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmadacyclineDrug

    po tablets

  • LinezolidDrug

    Also called Zyvox

    po tablets

Study groups in NCT02877927
Study groupRoleWhat they receive
OmadacyclineExperimentalOmadacycline tablets
Receives: Drug: Omadacycline
LinezolidActive comparatorLinezolid tablets
Receives: Drug: Linezolid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Screening; 48 to 72 hours after the first dose of test article

Secondary outcomes (2)

  1. Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit

    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.

    Measured: Screening; 7 to 14 days after the last day of therapy

  2. Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population

    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.

    Measured: Screening; 7 to 14 days after the last day of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion26 May 2017
  4. Study completion6 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
735 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02877927
Sponsor's protocol ID
PTK0796-ABSI-16301
Status last verified
Nov 2018
First submitted
15 Aug 2016
Last updated
30 Nov 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 39461915

  • 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.

    PubMed 35776862

  • 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.

    PubMed 33458763

  • 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.

    PubMed 33326848

  • 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.

    PubMed 31474458

  • 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.

    PubMed 31367742

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omadacycline and Linezolid in people with Bacterial Infections and Skin Structures and Soft Tissue Infections, run by Paratek Pharmaceuticals Inc at 50 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Early Clinical Response (time frame: Screening; 48 to 72 hours after the first dose of test article). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02877927, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.

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