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

NCT00865280 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2021-03-12

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Mary West · Paratek Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-04
Primary Completion
2010-04-15
Completion
2010-04-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00865280 on ClinicalTrials.gov