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

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: NCT00865280
Recruitment Status : Terminated (Terminated)
First Posted : March 19, 2009
Results First Posted : March 12, 2021
Last Update Posted : March 12, 2021
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Paratek Pharmaceuticals Inc

Brief Summary:
A Phase III 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
Skin Diseases, Infectious Drug: PTK 0796 Drug: linezolid Drug: moxifloxacin Phase 3

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-0804 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 : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Evaluator-Blinded, Phase 3 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid in the Treatment of Adults With Complicated Skin and Skin Structure Infection
Actual Study Start Date : April 4, 2009
Actual Primary Completion Date : April 15, 2010
Actual Study Completion Date : April 15, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Infections

Arm Intervention/treatment
Experimental: PTK 0796
PTK 0796 100 mg for injection; PTK 0796 tablet, 300 mg (2 x 150 mg tablets)
Drug: PTK 0796
PTK 0796 100 mg for injection; PTK 0796 tablet 150 mg
Other Name: omadacycline

Active Comparator: Linezolid
Gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; Gram negative treatment: moxifloxacin 400 mg tablet and moxifloxacin 400 mg IV infusion solution
Drug: linezolid
For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution
Other Name: Zyvox™; Avelox™

Drug: moxifloxacin
moxifloxacin 400 mg tablet; moxifloxacin 400 mg IV infusion solution




Primary Outcome Measures :
  1. Number of Participants Classified as a Sponsor-defined Clinical Success in the Intent-to-Treat (ITT) Population at End of Treatment [ Time Frame: up to 14 days ]
    Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the Case Report Form (CRF) check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.

  2. Number of Participants Classified as a Sponsor-defined Clinical Success in the ITT Population at Test of Cure [ Time Frame: 10 to 17 days after last dose of treatment (total treatment of up to 14 days) ]
    Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.

  3. Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the Clinically Evaluable (CE) Population at End of Treatment [ Time Frame: up to 14 days ]
    Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.

  4. Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at End of Treatment [ Time Frame: up to 14 days ]
    Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.

  5. Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure [ Time Frame: 10 to 17 days after last dose of treatment (total treatment of up to 14 days) ]
    Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.

  6. Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure [ Time Frame: 10 to 17 days after last dose of treatment (total treatment of up to 14 days) ]
    Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures.


Secondary Outcome Measures :
  1. Number of Participants With the Indicated Type of Adverse Event (AE) [ Time Frame: from the time of informed consent to Test of Cure (10 to 17 days after end of treatment [total treatment of up to 14 days) ]
    The assessment of safety was based mainly on the frequency of AEs, and summaries of vital signs and laboratory values (values classified as AE are captured in the AE module). An AE is defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, whether or not the event was considered causally related to the medical product. An AE could have been a new occurrence or an existing process that increased in intensity or frequency. AEs were deemed treatment-emergent if the start date was on or after the date of the first dose but was not present before that date or if the AE started before the date of the first dose and increased in severity on or after that date.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients, ages 18 years or older
  • Is expected to require ≥4 days of IV antibiotic therapy
  • Has an acute complicated skin and skin structure infection with findings of systemic inflammatory response
  • 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 >24 hr of a potentially effective systemic antibiotic immediately prior to study drug
  • Is nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865280


Locations
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United States, California
Paratek Recruiting Site
Fountain Valley, California, United States, 92708
Parateck Recruiting Site
La Mesa, California, United States, 91942
Paratek Recruiting Site
Oceanside, California, United States, 92056
Paratek Recruiting Site
San Diego, California, United States, 92114
Paratek Recruiting Site
San Jose, California, United States, 95154
United States, Georgia
Parateck Recruiting Site
Columbus, Georgia, United States, 31904
Paratek Recruiting Site
Savannah, Georgia, United States, 31406
Sponsors and Collaborators
Paratek Pharmaceuticals Inc
Novartis Pharmaceuticals
Investigators
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Study Director: Mary West Paratek Pharmaceuticals
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Responsible Party: Paratek Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00865280    
Other Study ID Numbers: PTK 0796 CSSI-0804
First Posted: March 19, 2009    Key Record Dates
Results First Posted: March 12, 2021
Last Update Posted: March 12, 2021
Last Verified: February 2021
Keywords provided by Paratek Pharmaceuticals Inc:
CSSI
Abscess
Wound
Cellulitis
Complicated Skin and Skin Structure Infections (cSSSI)
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Skin Diseases
Disease Attributes
Pathologic Processes
Bacterial Infections
Bacterial Infections and Mycoses
Moxifloxacin
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Synthesis Inhibitors