Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
330 participants
INTERVENTIONAL
2015-05-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Debio 1450 320/480 mg
After 2 doses of Debio 1450 IV (intravenous) therapy, the Debio 1450 320/480 mg daily dose group receives 240 mg Debio 1450 Oral + Linezolid Placebo twice daily (BID).
Debio 1450 IV
Intravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours).
Debio 1450 Oral
Oral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450).
Linezolid Placebo
Linezolid placebo will be supplied as film-coated compressed tablets.
Debio 1450 160/240 mg
After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group receives 120 mg Debio 1450 Oral + Debio 1450 Oral Placebo + Linezolid Placebo BID.
Debio 1450 IV
Intravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours).
Debio 1450 Oral
Oral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450).
Debio 1450 Oral Placebo
Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.
Linezolid Placebo
Linezolid placebo will be supplied as film-coated compressed tablets.
Placebo
After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.
Linezolid
Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.
Debio 1450 Oral Placebo
Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.
Vancomycin IV
Vancomycin will be administered BID every 12 ± 2 hours at doses of 1 g or 15 mg/kg as specified in local protocols, with the infusion rate adjusted to 2 hours.
Interventions
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Debio 1450 IV
Intravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours).
Debio 1450 Oral
Oral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450).
Linezolid
Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.
Debio 1450 Oral Placebo
Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.
Linezolid Placebo
Linezolid placebo will be supplied as film-coated compressed tablets.
Vancomycin IV
Vancomycin will be administered BID every 12 ± 2 hours at doses of 1 g or 15 mg/kg as specified in local protocols, with the infusion rate adjusted to 2 hours.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
1. the safety or well-being of the participant or study staff;
2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
3. the analysis of results
18 Years
70 Years
ALL
No
Sponsors
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Debiopharm International SA
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Wittke F, Vincent C, Chen J, Heller B, Kabler H, Overcash JS, Leylavergne F, Dieppois G. Afabicin, a First-in-Class Antistaphylococcal Antibiotic, in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Clinical Noninferiority to Vancomycin/Linezolid. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00250-20. doi: 10.1128/AAC.00250-20. Print 2020 Sep 21.
Other Identifiers
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218187
Identifier Type: OTHER
Identifier Source: secondary_id
Debio 1450-ABSSSI-201
Identifier Type: -
Identifier Source: org_study_id
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