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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716024
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc

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

Condition or disease Intervention/treatment Phase
Infectious Skin Disease Bacterial Skin Disease Drug: PTK0796 Drug: Linezolid Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Active Comparator-controlled,Evaluator-blinded, Multicenter Phase 2 Study Comparing PTK 0796 and Linezolid for the Treatment of Adults With Complicated Skin and Skin Structure Infections (cSSSI)
Actual Study Start Date : July 18, 2007
Actual Primary Completion Date : January 7, 2008
Actual Study Completion Date : January 7, 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid

Arm Intervention/treatment
Experimental: PTK0796 Drug: PTK0796
PTK 0796 100mg for injection; PTK 0796 tablet 100mg

Active Comparator: Linezolid Drug: Linezolid
Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets




Primary Outcome Measures :
  1. Clinical Success at Test of Cure Visit [ Time Frame: 10-17 days after last dose ]
    Clinical success is categorized as survival with the infection responding adequately such that antibiotics were no longer required (based on the investigator's assessment) without receiving rescue antibacterial therapy. Signs and symptoms of infection include the size, presence of drainage, tenderness, edema, erythema, and induration and were assessed by the investigator to make assessments of response.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT03716024    
Other Study ID Numbers: PTK0796-CSSI-0702
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paratek Pharmaceuticals Inc:
CSSSI
Additional relevant MeSH terms:
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Skin Diseases, Bacterial
Skin Diseases, Infectious
Skin Diseases
Infection
Bacterial Infections
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action