Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

September 17, 2020 updated by: Paratek Pharmaceuticals Inc

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)

A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

234

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients, ages 18 years to 80 years
  2. Has an acute complicated skin and skin structure infection
  3. 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:

  1. Has received an investigational drug within past 1 month
  2. Has been previously enrolled in this protocol
  3. Has received >48 hr of a potentially effective systemic antibiotic immediately prior to study drug
  4. Is nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 18, 2007

Primary Completion (ACTUAL)

January 7, 2008

Study Completion (ACTUAL)

January 7, 2008

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (ACTUAL)

October 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

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