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Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections

Information source: Melinta Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin Structure Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections

Intervention: delafloxacin (Drug); delafloxacin (Drug); tigecycline (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Melinta Therapeutics, Inc.

Official(s) and/or principal investigator(s):
Jeanne Breen, MD, Study Director, Affiliation: Melinta Therapeutics, Inc.

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.

Clinical Details

Official title: A Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of RX 3341 Compared With Tigecycline for the Treatment of Complicated Skin and Skin Structure Infections

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population

Secondary outcome: Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult (≥18 years of age) men or women with cSSSI

- Diagnosis of one of the following 3 types of cSSSI: wound infection that has

developed within 30 days of surgery, trauma, or a bite injury; abscess that has developed in the 7 days before enrollment; or cellulitis that has developed in the 7 days before enrollment

- Sexually active men and women of childbearing potential must agree to use an

acceptable form of contraception, as determined by the investigator, during participation in the study and for 30 days after the final dose of study drug

- The patient must be willing to comply with protocol requirements

Exclusion Criteria:

- Medical history of hypersensitivity or allergic reaction to quinolones, tetracycline

or tetracycline derivatives

- Chronic or underlying skin condition at the site of infection

- Infection involving prosthetic materials or foreign bodies (unless prosthetic

material will be removed within 24 hours), infection associated with a human bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene or gas gangrene, burns covering ≥10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis

- An infection that would normally have a high cure rate after surgical incision alone

- Any infection expected to require other antimicrobial agents in addition to study

drug

- Receipt of >24 hours of systemic antibiotic therapy in the 7 days before enrollment

- A severely compromised immune system

- History of Child-Pugh Class B or C liver disease or severe renal impairment

(creatinine clearance of <30 mL/minute)

- Pregnancy or lactation

Locations and Contacts

Clinical Research Puerto Rico, Inc, San Juan, Puerto Rico

Physician Alliance Research Center, Anaheim, California, United States

Quality of Life Medical Center, LLC, Hawaiian Gardens, California, United States

Tri City Medical Center, Oceanside, California, United States

Crest Clinical Trials, Santa Ana, California, United States

Internal Medicine Associates of Lee County, Fort Myers, Florida, United States

Joseph M. Still Research Foundation, Inc., Augusta, Georgia, United States

Southeast Regional Research Group, Columbus, Georgia, United States

Southeast Regional Research Group, Ludowici, Georgia, United States

Southeast Regional Research Group, Savannah, Georgia, United States

St. James Health Care, Butte, Montana, United States

Riverside Methodist Hospital, Columbus, Ohio, United States

West Houston Clinical Research Services, Houston, Texas, United States

Westbury Medical Clinic, Houston, Texas, United States

Additional Information

Starting date: June 2008
Last updated: June 30, 2014

Page last updated: August 23, 2015

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