Study of Debio 1450 for Bacterial Skin Infections

NCT02426918 | Completed Phase 2 Results

• 2 other identifiers: Debio 1450-ABSSSI-201218187
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator

  ECRR was defined as the percentage of responders to treatment at 48 to 72 hours from randomization. Responders were the participants who showed greater than or equal to (≥) 20% reduction in area of the primary lesion involving erythema, edema, or induration of the primary ABSSSI lesion (as assessed by the ruler method) at 48 to 72 hours compared to baseline.

  At 48 to 72 hours from randomization (Day 4)

Secondary Outcomes (4)

• Clinical Success Rate: Percentage of Participants Assessed by the Investigator as Responders at 48 to 72 Hours From Randomization, at End of Treatment (EOT) and Short-term Follow-up (STFU)

  48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)

• Clinical Success Rate: Percentage of Participants Assessed by the Sponsor as Responders After 7 to 10 Days of Treatment at EOT and STFU

  EOT (Day 12) and STFU (Day 19)

• Percentage of Participants With a Composite Assessment of Clinical Outcome (CACO) of Success

  48 to 72 hours after randomization (Day 4) and STFU (Day 19)

• Percentage of Participants Who Showed Microbiological Evidence of Cure 48 to 72 Hours From Randomization, EOT, and STFU

  48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)

Study Arms (3)

Debio 1450 320/480 mg

EXPERIMENTAL

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).

Drug: Debio 1450 IV; Drug: Debio 1450 Oral; Drug: Linezolid Placebo

Debio 1450 160/240 mg

EXPERIMENTAL

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.

Drug: Debio 1450 IV; Drug: Debio 1450 Oral; Drug: Debio 1450 Oral Placebo; Drug: Linezolid Placebo

Placebo

PLACEBO COMPARATOR

After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.

Drug: Linezolid; Drug: Debio 1450 Oral Placebo; Drug: Vancomycin IV

Interventions

Debio 1450 IV DRUG

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 160/240 mg; Debio 1450 320/480 mg

Debio 1450 Oral DRUG

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 160/240 mg; Debio 1450 320/480 mg

Linezolid DRUG

Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.

Placebo

Debio 1450 Oral Placebo DRUG

Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.

Debio 1450 160/240 mg; Placebo

Linezolid Placebo DRUG

Linezolid placebo will be supplied as film-coated compressed tablets.

Debio 1450 160/240 mg; Debio 1450 320/480 mg

Vancomycin IV DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (22)

Dream Team Clinical Research, LLC

Anaheim, California, 91776, United States

Location

Physician Alliance Research Center

Anaheim, California, 92804, United States

Location

Southbay Pharma Research

Buena Park, California, 90620, United States

Location

eStudySite - Chula Vista

Chula Vista, California, 91911, United States

Location

eStudySite - La Mesa

La Mesa, California, 91942, United States

Location

Long Beach Clinical Trials LLC

Long Beach, California, 90806, United States

Location

Alliance Research

Long Beach, California, 90813, United States

Location

Central Valley Research, LLC

Modesto, California, 95350, United States

Location

eStudySite - Oceanside

Oceanside, California, 92056, United States

Location

Olive View - UCLA Medical Center

Sylmar, California, 91342, United States

Location

Shands Burn Center at the University of Florida

Gainesville, Florida, 32610, United States

Location

Central Florida Internists

Orlando, Florida, 32811, United States

Location

Triple O Research Institute

West Palm Beach, Florida, 33401, United States

Location

Columbus Regional Research

Columbus, Georgia, 31904, United States

Location

Beaumont Infectious Disease Services

Royal Oak, Michigan, 48073, United States

Location

Mercury Street Medical Group PLLC

Butte, Montana, 59701, United States

Location

eStudySite - Las Vegas

Las Vegas, Nevada, 89109, United States

Location

South Jersey Infectious Disease

Somers Point, New Jersey, 08244, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

ID Clinical Research, Ltd.

Toledo, Ohio, 43608, United States

Location

East Montgomery County Clinic

Houston, Texas, 77070, United States

Location

Tidwell Medical Center

Splendora, Texas, 77372, United States

Location

Related Publications (1)

• 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.

  PMID: 32747361 DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

afabicin; Linezolid

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Vice President Clinical Research & Development
• Organization: Debiopharm International S.A.

info-international@debiopharm.com

4121 321 01 11

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 27, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 13, 2019
• Results First Posted: November 13, 2019

Record last verified: 2019-10

Locations

US (22)