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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-18

Study Completion Date

2008-01-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00876850

Skin Structures and Soft Tissue Infections

WITHDRAWN PHASE3

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

NCT00865280

Skin Diseases, Infectious

TERMINATED PHASE3

Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)

NCT01128530

Complicated Skin and Skin Structure Infections

COMPLETED PHASE2

MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection

NCT02269319

Bacterial Infections

COMPLETED PHASE2

GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection

NCT01209078

Skin Infections, Bacterial

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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-0702 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

See the medical conditions and disease areas that this research is targeting or investigating.

Infectious Skin Disease Bacterial Skin Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PTK 0796

Group Type EXPERIMENTAL

PTK 0796

Intervention Type DRUG

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

Linezolid

Group Type ACTIVE_COMPARATOR

Linezolid

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PTK 0796

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

Intervention Type DRUG

Linezolid

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients, ages 18 years to 80 years
2. Has an acute complicated skin and skin structure infection
3. 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

1. Has received an investigational drug within past 1 month
2. Has been previously enrolled in this protocol
3. Has received \>48 hr of a potentially effective systemic antibiotic immediately prior to study drug
4. Is nursing

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No