- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03716024
Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
A Randomized, Evaluator-Blinded, Phase 2 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid (Zyvox®) in the Treatment of Adults With Complicated Skin and Skin Structure Infection (cSSSI)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.
In PTK 0796-CSSI-0702 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Anaheim, California, United States, 92804
- Paratek Recruiting Site
-
Buena Park, California, United States, 90620
- Paratek Recruiting Site
-
Chula Vista, California, United States, 91911
- Paratek Recruiting Site
-
Hawaiian Gardens, California, United States, 90716
- Paratek Recruiting Site
-
Oceanside, California, United States, 92056
- Paratek Recruiting Site
-
San Jose, California, United States, 95124
- Paratek Recruiting Site
-
-
Indiana
-
Indianapolis, Indiana, United States, 46280
- Paratek Recruiting Site
-
-
Montana
-
Butte, Montana, United States, 59701
- Paratek Recruiting Site
-
-
Texas
-
Electra, Texas, United States, 76360
- Paratek Recruiting Site
-
Houston, Texas, United States, 77074
- Paratek Recruiting Site
-
Wichita Falls, Texas, United States, 76301
- Paratek Recruiting Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients, ages 18 years to 80 years
- Has an acute complicated skin and skin structure infection
- Female patients must not be pregnant at the time of enrollment and 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:
- Has received an investigational drug within past 1 month
- Has been previously enrolled in this protocol
- Has received >48 hr of a potentially effective systemic antibiotic immediately prior to study drug
- Is nursing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PTK 0796
|
PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg
|
ACTIVE_COMPARATOR: Linezolid
|
Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population
Time Frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
|
Clinical response is defined as clinical success (CS), which is categorized as a determination by a blinded evaluator (BE) that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant (par.) received ≥1 dose of test article, the par.
did not receive non-study antibiotics on >2 calendar days from Day 1 to the Test of Cure assessment, and the par.
did not meet any of the criteria for clinical failure.
Clinical failure (CF) is categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the par.
received potentially effective antibiotics for treatment of the primary infection site on >2 days after study enrollment.
A classification of indeterminate is used for any outcome that was not classified as CS or CF.
|
10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
|
Number of Participants With Clinical Response in the Clinically Evaluable (CE) Population
Time Frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
|
Clinical response is defined as CS, which was categorized as a determination by a BE that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant received ≥1 dose of test article, the participant did not receive non-study antibiotics on >2 calendar days from Day 1 to the Test of Cure assessment, and the participant did not meet any of the criteria for clinical failure.
CF was categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the participant received potentially effective antibiotics for treatment of the primary infection site on >2 days after study enrollment.
A classification of indeterminate is used for any outcome that was not classified as CS or CF.
|
10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Microbiologic Response in the mITT Population
Time Frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
|
Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study.
|
10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
|
Number of Participants With Microbiologic Response in the Microbiologically Evaluable (ME) Population
Time Frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
|
Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study.
|
10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTK0796-CSSI-0702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infectious Skin Disease
-
PfizerCompletedIntra-Abdominal Infections | Skin Disease, Infectious
-
Johns Hopkins Bloomberg School of Public HealthCompleted
-
Center for Innovation and Research OrganizationCompleted
-
Cubist Pharmaceuticals LLCCompletedSkin Diseases, InfectiousUnited States, India, Panama
-
Christiana Care Health ServicesCompleted
-
Johnson & Johnson Pharmaceutical Research & Development...PriCara, Unit of Ortho-McNeil, Inc.Completed
-
BayerTerminatedSkin Disease, InfectiousRussian Federation, Mexico, Singapore
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedSkin Diseases, InfectiousTaiwan
-
The University of Texas Health Science Center at...CompletedSkin Diseases, Infectious | Soft Tissue InfectionsUnited States
Clinical Trials on PTK 0796
-
NodThera LimitedRecruitingCardiovascular DiseasesUnited States
-
Paratek Pharmaceuticals IncWithdrawnSkin Structures and Soft Tissue Infections
-
Paratek Pharmaceuticals IncNovartis PharmaceuticalsTerminatedSkin Diseases, InfectiousUnited States
-
London Vision ClinicOptana GmbHRecruitingCorneal AstigmatismUnited Kingdom
-
Oslo University HospitalRecruiting
-
Federal University of São PauloCompleted
-
SCRI Development Innovations, LLCNovartisCompletedSolid Tumors | Refractory MalignancyUnited States
-
M.D. Anderson Cancer CenterNovartisCompletedAcute Myelogenous Leukemia | Chronic Myelogenous Leukemia | Agnogenic Myeloid MetaplasiaUnited States
-
Emory UniversityTerminatedRecurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Chronic Myelogenous Leukemia, BCR-ABL1 PositiveUnited States
-
Federal University of São PauloUnknownKeratitis | Corneal OpacityBrazil