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

Skin Structures and Soft Tissue Infections Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00876850
• Other study ID #: PTK 0796-CSSI-0805
• Status: Withdrawn
• Phase: Phase 3
• First received: April 6, 2009
• Last updated: May 8, 2012
• Start date: July 2009
• Est. completion date: August 2010

Study information

• Verified date: May 2012
• Source: Paratek Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of HealthBelgium: Federal Agency for Medicinal Products and Health ProductsBrazil: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesChile: Instituto de Salud Pública de ChileIsrael: Ministry of HealthPeru: Ministry of HealthPoland: Ministry of HealthRussia: FSI Scientific Center of Expertise of Medical ApplicationSouth Africa: Medicines Control CouncilUkraine: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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-0805 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by the FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Skin Structures and Soft Tissue Infections
• Soft Tissue Infections

Intervention

Drug:
• PTK 0796
PTK 0796 100mg for injection; PTK 0796 tablet 150mg
• Linezolid
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Paratek Pharmaceuticals Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success at follow-up		4 weeks after enrollment	No
Secondary	To evaluate safety of dosing regimens		4 weeks after enrollment	No