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

NCT00865280 | Terminated Phase 3 Results

• 1 other identifier: PTK 0796 CSSI-0804
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 7

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).

Conditions

Skin Diseases, Infectious

Keywords

CSSI; Abscess; Wound; Cellulitis; Complicated Skin and Skin Structure Infections (cSSSI)

Outcome Measures

Primary Outcomes (6)

• Number of Participants Classified as a Sponsor-defined Clinical Success in the Intent-to-Treat (ITT) Population at End of Treatment

  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.

  up to 14 days

• Number of Participants Classified as a Sponsor-defined Clinical Success in the ITT Population at Test of Cure

  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.

  10 to 17 days after last dose of treatment (total treatment of up to 14 days)

• Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the Clinically Evaluable (CE) Population at End of Treatment

  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.

  up to 14 days

• Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at End of Treatment

  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.

  up to 14 days

• Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure

  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.

  10 to 17 days after last dose of treatment (total treatment of up to 14 days)

• Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure

  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.

  10 to 17 days after last dose of treatment (total treatment of up to 14 days)

Secondary Outcomes (1)

• Number of Participants With the Indicated Type of Adverse Event (AE)

  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)

Study Arms (2)

PTK 0796

EXPERIMENTAL

PTK 0796 100 mg for injection; PTK 0796 tablet, 300 mg (2 x 150 mg tablets)

Drug: PTK 0796

Linezolid

ACTIVE COMPARATOR

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; Drug: moxifloxacin

Interventions

PTK 0796 DRUG

PTK 0796 100 mg for injection; PTK 0796 tablet 150 mg

Also known as: omadacycline

PTK 0796

linezolid DRUG

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

Also known as: Zyvox™; Avelox™

Linezolid

moxifloxacin DRUG

moxifloxacin 400 mg tablet; moxifloxacin 400 mg IV infusion solution

Linezolid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paratek Pharmaceuticals Inc: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (7)

Paratek Recruiting Site

Fountain Valley, California, 92708, United States

Location

Parateck Recruiting Site

La Mesa, California, 91942, United States

Location

Paratek Recruiting Site

Oceanside, California, 92056, United States

Location

Paratek Recruiting Site

San Diego, California, 92114, United States

Location

Paratek Recruiting Site

San Jose, California, 95154, United States

Location

Parateck Recruiting Site

Columbus, Georgia, 31904, United States

Location

Paratek Recruiting Site

Savannah, Georgia, 31406, United States

Location

MeSH Terms

Conditions

Skin Diseases, Infectious; Abscess; Wounds and Injuries; Cellulitis

Interventions

7-dimethylamino-9-(2,2-dimethylpropyl)aminomethylcycline; omadacycline; Linezolid; Moxifloxacin

Condition Hierarchy (Ancestors)

Infections; Skin Diseases; Skin and Connective Tissue Diseases; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Changes in Food and Drug Administration (FDA) criteria for the identification and enrollment of participants with complicated skin and skin structure infections as well as the primary endpoint led to administrative termination of the study.

Results Point of Contact

• Title: Paratek Medical Information
• Organization: Paratek Pharmaceuticals, Inc.

medinfo@paratekpharma.com

1-833-727-2835

Study Officials

• Mary West

  Paratek Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 19, 2009
• Study Start: April 4, 2009
• Primary Completion: April 15, 2010
• Study Completion: April 15, 2010
• Last Updated: March 12, 2021
• Results First Posted: March 12, 2021

Record last verified: 2021-02

Locations

US (7)