Bacterial Infections Clinical Trial
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)
| Verified date | November 2018 |
| Source | Paratek Pharmaceuticals Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 735 |
| Est. completion date | June 6, 2017 |
| Est. primary completion date | May 26, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Site 601 | Anaheim | California |
| United States | Site 616 | Anaheim | California |
| United States | Site 636 | Bakersfield | California |
| United States | Site 633 | Baytown | Texas |
| United States | Site 620 | Birmingham | Alabama |
| United States | Site 657 | Boston | Massachusetts |
| United States | Site 606 | Buena Park | California |
| United States | Site 602 | Butte | Montana |
| United States | Site 605 | Channelview | Texas |
| United States | Site 604 | Chula Vista | California |
| United States | Site 644 | Council Bluffs | Iowa |
| United States | Site 614 | DeLand | Florida |
| United States | Site 655 | Fort Myers | Florida |
| United States | Site 656 | Homestead | Florida |
| United States | Site 625 | Houston | Texas |
| United States | Site 627 | Houston | Texas |
| United States | Site 659 | Huntington Beach | California |
| United States | Site 635 | Jackson | Tennessee |
| United States | Site 647 | Jackson Heights | New York |
| United States | Site 608 | La Mesa | California |
| United States | Site 618 | Laguna Hills | California |
| United States | Site 623 | Las Vegas | Nevada |
| United States | Site 612 | Long Beach | California |
| United States | Site 626 | Miami | Florida |
| United States | Site 631 | Miami | Florida |
| United States | Site 637 | Miami | Florida |
| United States | Site 641 | Miami | Florida |
| United States | Site 645 | Miami | Florida |
| United States | Site 653 | Miami | Florida |
| United States | Site 654 | Miami | Florida |
| United States | Site 658 | Miami | Florida |
| United States | Site 640 | Miami Lakes | Florida |
| United States | Site 662 | Miami Lakes | Florida |
| United States | Site 642 | Mobile | Alabama |
| United States | Site 648 | Modesto | California |
| United States | Site 632 | Mount Airy | North Carolina |
| United States | Site 610 | Oceanside | California |
| United States | Site 607 | Rapid City | South Dakota |
| United States | Site 609 | Saint Cloud | Florida |
| United States | Site 617 | Saint Louis | Missouri |
| United States | Site 615 | San Diego | California |
| United States | Site 621 | San Diego | California |
| United States | Site 613 | San Francisco | California |
| United States | Site 628 | Smyrna | Tennessee |
| United States | Site 630 | Somers Point | New Jersey |
| United States | Site 603 | Stockton | California |
| United States | Site 634 | Sugar Land | Texas |
| United States | Site 649 | Toledo | Ohio |
| United States | Site 650 | Torrance | California |
| United States | Site 646 | Ventura | California |
| Lead Sponsor | Collaborator |
|---|---|
| Paratek Pharmaceuticals Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 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. | 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. | Screening; 7 to 14 days after the last day of therapy |
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