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

NCT00876850 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-05-09

No results posted yet for this study

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

Interventions

DRUG

PTK 0796

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

DRUG

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

Sponsors & Collaborators

  • Paratek Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Robert Arbeit, MD · Paratek Pharmaceuticals Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-07-31
Completion
2010-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00876850 on ClinicalTrials.gov