Clinical trial NCT02426918: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Infections
Lead sponsor: Debiopharm International SA
Sponsor class: INDUSTRY
First posted: 2015-04-27
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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

Primary outcomes:
measure: Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator
timeFrame: At 48 to 72 hours from randomization (Day 4)
Secondary outcomes:
measure: 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)
timeFrame: 48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)
measure: Clinical Success Rate: Percentage of Participants Assessed by the Sponsor as Responders After 7 to 10 Days of Treatment at EOT and STFU
timeFrame: EOT (Day 12) and STFU (Day 19)
measure: Percentage of Participants With a Composite Assessment of Clinical Outcome (CACO) of Success
timeFrame: 48 to 72 hours after randomization (Day 4) and STFU (Day 19)
measure: Percentage of Participants Who Showed Microbiological Evidence of Cure 48 to 72 Hours From Randomization, EOT, and STFU
timeFrame: 48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Dream Team Clinical Research, LLC
state: California
city: Anaheim
country: United States
facility: Physician Alliance Research Center
state: California
city: Buena Park
country: United States
facility: Southbay Pharma Research
state: California
city: Chula Vista
country: United States
facility: eStudySite - Chula Vista
state: California
city: La Mesa
country: United States
facility: eStudySite - La Mesa
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials LLC
state: California
city: Long Beach
country: United States
facility: Alliance Research
state: California
city: Modesto
country: United States
facility: Central Valley Research, LLC
state: California
city: Oceanside
country: United States
facility: eStudySite - Oceanside
state: California
city: Sylmar
country: United States
facility: Olive View - UCLA Medical Center
state: California
city: Gainesville
country: United States
facility: Shands Burn Center at the University of Florida
state: Florida
city: Orlando
country: United States
facility: Central Florida Internists
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research
state: Georgia
city: Royal Oak
country: United States
facility: Beaumont Infectious Disease Services
state: Michigan
city: Butte
country: United States
facility: Mercury Street Medical Group PLLC
state: Montana
city: Las Vegas
country: United States
facility: eStudySite - Las Vegas
state: Nevada
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Toledo
country: United States
facility: ID Clinical Research, Ltd.
state: Ohio
city: Houston
country: United States
facility: East Montgomery County Clinic
state: Texas
city: Splendora
country: United States
facility: Tidwell Medical Center
state: Texas
Study officials:
References:
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.