NCT00865280

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Paratek Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Skin Diseases, Infectious

Interventions

Type	Name	Description
DRUG	PTK 0796	PTK 0796 100 mg for injection; PTK 0796 tablet 150 mg
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
DRUG	moxifloxacin	moxifloxacin 400 mg tablet; moxifloxacin 400 mg IV infusion solution

Timeline

• Start date: 2009-04-04
• Primary completion: 2010-04-15
• Completion: 2010-04-15
• First posted: 2009-03-19
• Last updated: 2021-03-12
• Results posted: 2021-03-12

Locations

7 sites across 1 country: United States