Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

NCT00876850 | Withdrawn Phase 3

• 1 other identifier: PTK 0796-CSSI-0805
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 Structures and Soft Tissue Infections

Keywords

cSSI; Abscess; Would; Cellulitis; Complicated Skin and Skin Structure Infections (cSSSI)

Outcome Measures

Primary Outcomes (1)

• Clinical success at follow-up

  4 weeks after enrollment

Secondary Outcomes (1)

• To evaluate safety of dosing regimens

  4 weeks after enrollment

Study Arms (2)

PTK 0796

EXPERIMENTAL

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

Drug: PTK 0796

Linezolid

ACTIVE COMPARATOR

For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution

Drug: Linezolid

Interventions

PTK 0796 DRUG

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

PTK 0796

Linezolid DRUG

For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400mg tablets and pre-mixed 400mg IV infusion solution

Also known as: Zyvox™; Avelox™

Linezolid

Eligibility Criteria

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

You may qualify if:

• Has and acute complicated skin and skin structure infection with findings of systemic inflammatory response
• Patients, ages 18 years or older
• Is expected to require greater than or equal to 4 days antibiotic therapy
• 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 the past 1 month
• Has been previously enrolled in this protocol
• Has received \>48hr of potentially effective systemic antibiotic immediately prior to study drug
• Is nursing

Sponsors & Collaborators

• Paratek Pharmaceuticals Inc: lead

MeSH Terms

Conditions

Soft Tissue Infections; Abscess; Cellulitis

Interventions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert Arbeit, MD

  Paratek Pharmaceuticals Inc

  STUDY DIRECTOR

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: April 6, 2009
• First Posted: April 7, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: May 9, 2012

Record last verified: 2012-05