Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omadacycline | Experimental | Omadacycline tablets |
|
| Linezolid | Active Comparator | Linezolid tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omadacycline | Drug | po tablets |
| |
| Linezolid |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amy Manley | Senior Director, Clinical Operations | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 620 | Birmingham | Alabama | 35215 | United States | ||
| Site 642 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39461915 | Derived | 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. | |
| 35776862 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Omadacycline | Participants received omadacycline 450 milligrams (mg) orally every 24 hours (q24h) for 2 doses, followed by 300 mg orally q24h. The total treatment duration was 7 to 14 days. Participants received active omadacycline tablets and over-encapsulated linezolid placebo tablets. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 22, 2016 | Nov 28, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
po tablets |
|
|
| 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 | 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. | Screening; 7 to 14 days after the last day of therapy |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Site 616 | Anaheim | California | 92801 | United States |
| Site 601 | Anaheim | California | 92804 | United States |
| Site 636 | Bakersfield | California | 93301 | United States |
| Site 606 | Buena Park | California | 90620 | United States |
| Site 604 | Chula Vista | California | 91911 | United States |
| Site 659 | Huntington Beach | California | 92647 | United States |
| Site 608 | La Mesa | California | 91942 | United States |
| Site 618 | Laguna Hills | California | 92653 | United States |
| Site 612 | Long Beach | California | 90813 | United States |
| Site 648 | Modesto | California | 95350 | United States |
| Site 610 | Oceanside | California | 92056 | United States |
| Site 615 | San Diego | California | 92114 | United States |
| Site 621 | San Diego | California | 92119 | United States |
| Site 613 | San Francisco | California | 94115 | United States |
| Site 603 | Stockton | California | 95204 | United States |
| Site 650 | Torrance | California | 90502 | United States |
| Site 646 | Ventura | California | 93003 | United States |
| Site 614 | DeLand | Florida | 32720 | United States |
| Site 655 | Fort Myers | Florida | 33901 | United States |
| Site 656 | Homestead | Florida | 33030 | United States |
| Site 631 | Miami | Florida | 33015 | United States |
| Site 658 | Miami | Florida | 33125 | United States |
| Site 654 | Miami | Florida | 33134 | United States |
| Site 626 | Miami | Florida | 33144 | United States |
| Site 637 | Miami | Florida | 33144 | United States |
| Site 653 | Miami | Florida | 33145 | United States |
| Site 641 | Miami | Florida | 33175 | United States |
| Site 645 | Miami | Florida | 33175 | United States |
| Site 640 | Miami Lakes | Florida | 33016 | United States |
| Site 662 | Miami Lakes | Florida | 33104 | United States |
| Site 609 | Saint Cloud | Florida | 34769 | United States |
| Site 644 | Council Bluffs | Iowa | 51503 | United States |
| Site 657 | Boston | Massachusetts | 02115 | United States |
| Site 617 | St Louis | Missouri | 63128 | United States |
| Site 602 | Butte | Montana | 59701 | United States |
| Site 623 | Las Vegas | Nevada | 89109 | United States |
| Site 630 | Somers Point | New Jersey | 08244 | United States |
| Site 647 | Jackson Heights | New York | 11372 | United States |
| Site 632 | Mount Airy | North Carolina | 27030 | United States |
| Site 649 | Toledo | Ohio | 43608 | United States |
| Site 607 | Rapid City | South Dakota | 57702 | United States |
| Site 635 | Jackson | Tennessee | 38305 | United States |
| Site 628 | Smyrna | Tennessee | 37167 | United States |
| Site 633 | Baytown | Texas | 77521 | United States |
| Site 605 | Channelview | Texas | 77530 | United States |
| Site 625 | Houston | Texas | 77008 | United States |
| Site 627 | Houston | Texas | 77084 | United States |
| Site 634 | Sugar Land | Texas | 77479 | United States |
| 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. |
| 33458763 | Derived | 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. |
| 33326848 | Derived | 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. |
| 31474458 | Derived | 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. |
| 31367742 | Derived | 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. |
| Linezolid |
Participants received linezolid 600 mg orally every 12 hours (q12h). The total treatment duration was 7 to 14 days. Participants received omadacycline placebo tablets and over-encapsulated active linezolid tablets. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population: all randomized participants who received test article
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Omadacycline | Participants received omadacycline 450 milligrams (mg) orally every 24 hours (q24h) for 2 doses, followed by 300 mg orally q24h. The total treatment duration was 7 to 14 days. Participants received active omadacycline tablets and over-encapsulated linezolid placebo tablets. |
| BG001 | Linezolid | Participants received linezolid 600 mg orally every 12 hours (q12h). The total treatment duration was 7 to 14 days. Participants received omadacycline placebo tablets and over-encapsulated active linezolid tablets. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified Intent-to-Treat (mITT) Population: all randomized participants without a baseline sole Gram-negative ABSSSI pathogen | Posted | Count of Participants | Participants | Screening; 48 to 72 hours after the first dose of test article |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | mITT Population | Posted | Count of Participants | Participants | Screening; 7 to 14 days after the last day of therapy |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | CE-PTE Population: all participants in the mITT Population meeting additional pre-defined criteria | Posted | Count of Participants | Participants | Screening; 7 to 14 days after the last day of therapy |
|
Adverse events were assessed from the signing of Informed Consent Form to the time of the Final Follow-up assessment (up to 30 to 37 days after the first dose of test article).
Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received test article (either active or placebo). Treatment-emergent adverse events, defined as events occurring after the first dose of active test article, are reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omadacycline | Participants received omadacycline 450 milligrams (mg) orally every 24 hours (q24h) for 2 doses, followed by 300 mg orally q24h. The total treatment duration was 7 to 14 days. Participants received active omadacycline tablets and over-encapsulated linezolid placebo tablets. | 0 | 368 | 5 | 368 | 166 | 368 |
| EG001 | Linezolid | Participants received linezolid 600 mg orally every 12 hours (q12h). The total treatment duration was 7 to 14 days. Participants received omadacycline placebo tablets and over-encapsulated active linezolid tablets. | 1 | 367 | 5 | 367 | 83 | 367 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug Withdrawal Syndrome | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Staphylococcal Bacteraemia | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
The only disclosure restriction on the Principal Investigator is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can request changes to the communication and require the removal of confidential information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul McGovern; Vice President, Clinical Affairs | Paratek Pharmaceuticals, Inc. | 484-751-4935 | Paul.Mcgovern@paratekpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2017 | Nov 28, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D018461 | Soft Tissue Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591640 | omadacycline |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Indeterminate |
|
Participants received linezolid 600 mg orally every 12 hours (q12h). The total treatment duration was 7 to 14 days. Participants received omadacycline placebo tablets and over-encapsulated active linezolid tablets. |
|
|
|
Participants received linezolid 600 mg orally every 12 hours (q12h). The total treatment duration was 7 to 14 days. Participants received omadacycline placebo tablets and over-encapsulated active linezolid tablets. |
|
|
|