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

NCT03716024 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2020-10-12

Study results available
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Summary

A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

Conditions

  • Infectious Skin Disease
  • Bacterial Skin Disease

Interventions

DRUG

PTK 0796

PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg

DRUG

Linezolid

Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets

Sponsors & Collaborators

  • Paratek Pharmaceuticals Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-18
Primary Completion
2008-01-07
Completion
2008-01-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03716024 on ClinicalTrials.gov