Study of Debio 1450 for Bacterial Skin Infections

Completed · Phase 2 · Has a placebo group

Conditions studied: Bacterial Infections

In brief

The primary objective of this study is to evaluate the efficacy of 2 different doses of intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in the treatment of patients with staphylococcal ABSSSI.

Key facts

Study ID

NCT02426918

Run by

Debiopharm International SA

People needed

330

Starts

2015-05-01

Expected to finish

2016-09-01

Last updated by the study team

2019-11-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has clinically documented infection of the skin or skin structure suspected or documented to be caused by a staphylococcal pathogen
• Meets other protocol-specified criteria for qualification and contraception
• Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
• Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

You may not qualify if…

• Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
• Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
• the safety or well-being of the participant or study staff;
• the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
• the analysis of results

Where it is running

• Dream Team Clinical Research, LLC — Anaheim, California, United States
• Physician Alliance Research Center — Anaheim, California, United States
• Southbay Pharma Research — Buena Park, California, United States
• eStudySite - Chula Vista — Chula Vista, California, United States
• eStudySite - La Mesa — La Mesa, California, United States
• Long Beach Clinical Trials LLC — Long Beach, California, United States
• Alliance Research — Long Beach, California, United States
• Central Valley Research, LLC — Modesto, California, United States
• eStudySite - Oceanside — Oceanside, California, United States
• Olive View - UCLA Medical Center — Sylmar, California, United States
• Shands Burn Center at the University of Florida — Gainesville, Florida, United States
• Central Florida Internists — Orlando, Florida, United States
• Triple O Research Institute — West Palm Beach, Florida, United States
• Columbus Regional Research — Columbus, Georgia, United States
• Beaumont Infectious Disease Services — Royal Oak, Michigan, United States
• Mercury Street Medical Group PLLC — Butte, Montana, United States
• eStudySite - Las Vegas — Las Vegas, Nevada, United States
• South Jersey Infectious Disease — Somers Point, New Jersey, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• ID Clinical Research, Ltd. — Toledo, Ohio, United States
• East Montgomery County Clinic — Houston, Texas, United States
• Tidwell Medical Center — Splendora, Texas, United States

Full record on ClinicalTrials.gov

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