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Study of Debio 1450 for Bacterial Skin Infections

Primary Purpose

Bacterial Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Debio 1450 IV
Debio 1450 Oral
Linezolid
Debio 1450 Oral Placebo
Linezolid Placebo
Vancomycin IV
Sponsored by
Debiopharm International SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    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

Sites / Locations

  • Dream Team Clinical Research, LLC
  • Physician Alliance Research Center
  • Southbay Pharma Research
  • eStudySite - Chula Vista
  • eStudySite - La Mesa
  • Long Beach Clinical Trials LLC
  • Alliance Research
  • Central Valley Research, LLC
  • eStudySite - Oceanside
  • Olive View - UCLA Medical Center
  • Shands Burn Center at the University of Florida
  • Central Florida Internists
  • Triple O Research Institute
  • Columbus Regional Research
  • Beaumont Infectious Disease Services
  • Mercury Street Medical Group PLLC
  • eStudySite - Las Vegas
  • South Jersey Infectious Disease
  • Holy Name Medical Center
  • ID Clinical Research, Ltd.
  • East Montgomery County Clinic
  • Tidwell Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Debio 1450 320/480 mg

Debio 1450 160/240 mg

Placebo

Arm Description

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).

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
The Investigator Assessment of Clinical Outcome (IACO) of treatment was assessed for each participant as success or failure at 48 to 72 hours after randomization at EOT and STFU visits. Clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms, or complications attributable to ABSSSI such that no further antibiotic therapy is required for treatment of original site of infection. Clinical failure was requirement for additional antibiotic therapy for treatment of the original site of infection or incision and drainage of ABSSSI site that was not both anticipated and completed within a 48- to 72-hour window following randomization, or unplanned major surgical intervention required due to failure of study medication or development of osteomyelitis after baseline. Participants who met both success criteria and none of failure criteria were considered as a clinical success for IACO.
Clinical Success Rate: Percentage of Participants Assessed by the Sponsor as Responders After 7 to 10 Days of Treatment at EOT and STFU
The Sponsor's Assessment of Clinical Outcome was obtained at EOT and STFU visits based on IACO and additional criteria. Sponsor assessed participants as clinical failure if they required non-study or rescue antibiotics due to lack of efficacy after at least 48 hours from randomization or experienced drug-related serious adverse events (SAEs) or discontinuation of study medication for drug-related AEs or required antibiotic therapy for longer than 10 days or had the need for unplanned surgical intervention >48 hours after randomization. As per IACO, clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms or complications. Clinical failure was requirement for additional antibiotic therapy or incision and drainage of ABSSSI site or unplanned major surgical intervention or development of osteomyelitis.
Percentage of Participants With a Composite Assessment of Clinical Outcome (CACO) of Success
CACO of treatment was determined as a combined outcome of early response to treatment (at 48 to 72 hours from randomization) and IACO at the STFU visit. Participants had a CACO of success if they met both of the following criteria: An early response to treatment (at 48 to 72 hours from randomization) (ECR = responder) and a clinical outcome of success at the STFU visit (7 to 14 days after EOT) based on IACO (IACO = success).
Percentage of Participants Who Showed Microbiological Evidence of Cure 48 to 72 Hours From Randomization, EOT, and STFU
The microbiological outcome was assessed by the sponsor at 48 to 72 hours from randomization, EOT and STFU. It was based on blood and skin lesion identification results from baseline samples and skin lesion identification results from baseline samples and skin lesion identification results from follow-up samples as well as on, molecular typing results, and the IACO. Microbiological eradication rate was defined as proportion of participants with 'Documented Eradication' (absence of baseline pathogen(s) in follow-up cultures of the original site of infection.) or 'Presumed Eradication' (no material available for culture and an IACO of 'Success') in relation to the total number of participants in the respective treatment group.

Full Information

First Posted
April 22, 2015
Last Updated
October 24, 2019
Sponsor
Debiopharm International SA
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1. Study Identification

Unique Protocol Identification Number
NCT02426918
Brief Title
Study of Debio 1450 for Bacterial Skin Infections
Official Title
A Phase 2, Randomized, Double-Blind, Multicenter Study of Safety, Tolerability, and Efficacy of Debio 1450 vs Vancomycin (IV)/Linezolid (Oral) in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Due to Staphylococcus Sensitive or Resistant to Methicillin
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Debiopharm International SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Debio 1450 320/480 mg
Arm Type
Experimental
Arm Description
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).
Arm Title
Debio 1450 160/240 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.
Intervention Type
Drug
Intervention Name(s)
Debio 1450 IV
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Debio 1450 Oral
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Linezolid
Intervention Description
Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.
Intervention Type
Drug
Intervention Name(s)
Debio 1450 Oral Placebo
Intervention Description
Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.
Intervention Type
Drug
Intervention Name(s)
Linezolid Placebo
Intervention Description
Linezolid placebo will be supplied as film-coated compressed tablets.
Intervention Type
Drug
Intervention Name(s)
Vancomycin IV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator
Description
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.
Time Frame
At 48 to 72 hours from randomization (Day 4)
Secondary Outcome Measure Information:
Title
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)
Description
The Investigator Assessment of Clinical Outcome (IACO) of treatment was assessed for each participant as success or failure at 48 to 72 hours after randomization at EOT and STFU visits. Clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms, or complications attributable to ABSSSI such that no further antibiotic therapy is required for treatment of original site of infection. Clinical failure was requirement for additional antibiotic therapy for treatment of the original site of infection or incision and drainage of ABSSSI site that was not both anticipated and completed within a 48- to 72-hour window following randomization, or unplanned major surgical intervention required due to failure of study medication or development of osteomyelitis after baseline. Participants who met both success criteria and none of failure criteria were considered as a clinical success for IACO.
Time Frame
48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)
Title
Clinical Success Rate: Percentage of Participants Assessed by the Sponsor as Responders After 7 to 10 Days of Treatment at EOT and STFU
Description
The Sponsor's Assessment of Clinical Outcome was obtained at EOT and STFU visits based on IACO and additional criteria. Sponsor assessed participants as clinical failure if they required non-study or rescue antibiotics due to lack of efficacy after at least 48 hours from randomization or experienced drug-related serious adverse events (SAEs) or discontinuation of study medication for drug-related AEs or required antibiotic therapy for longer than 10 days or had the need for unplanned surgical intervention >48 hours after randomization. As per IACO, clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms or complications. Clinical failure was requirement for additional antibiotic therapy or incision and drainage of ABSSSI site or unplanned major surgical intervention or development of osteomyelitis.
Time Frame
EOT (Day 12) and STFU (Day 19)
Title
Percentage of Participants With a Composite Assessment of Clinical Outcome (CACO) of Success
Description
CACO of treatment was determined as a combined outcome of early response to treatment (at 48 to 72 hours from randomization) and IACO at the STFU visit. Participants had a CACO of success if they met both of the following criteria: An early response to treatment (at 48 to 72 hours from randomization) (ECR = responder) and a clinical outcome of success at the STFU visit (7 to 14 days after EOT) based on IACO (IACO = success).
Time Frame
48 to 72 hours after randomization (Day 4) and STFU (Day 19)
Title
Percentage of Participants Who Showed Microbiological Evidence of Cure 48 to 72 Hours From Randomization, EOT, and STFU
Description
The microbiological outcome was assessed by the sponsor at 48 to 72 hours from randomization, EOT and STFU. It was based on blood and skin lesion identification results from baseline samples and skin lesion identification results from baseline samples and skin lesion identification results from follow-up samples as well as on, molecular typing results, and the IACO. Microbiological eradication rate was defined as proportion of participants with 'Documented Eradication' (absence of baseline pathogen(s) in follow-up cultures of the original site of infection.) or 'Presumed Eradication' (no material available for culture and an IACO of 'Success') in relation to the total number of participants in the respective treatment group.
Time Frame
48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Dream Team Clinical Research, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
91776
Country
United States
Facility Name
Physician Alliance Research Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Southbay Pharma Research
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
eStudySite - Chula Vista
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
eStudySite - La Mesa
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Long Beach Clinical Trials LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Alliance Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Central Valley Research, LLC
City
Modesto
State/Province
California
ZIP/Postal Code
95350
Country
United States
Facility Name
eStudySite - Oceanside
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Olive View - UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Shands Burn Center at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Central Florida Internists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32811
Country
United States
Facility Name
Triple O Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Columbus Regional Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Beaumont Infectious Disease Services
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Mercury Street Medical Group PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
eStudySite - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
South Jersey Infectious Disease
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
ID Clinical Research, Ltd.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
East Montgomery County Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Tidwell Medical Center
City
Splendora
State/Province
Texas
ZIP/Postal Code
77372
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32747361
Citation
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.
Results Reference
derived

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Study of Debio 1450 for Bacterial Skin Infections

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