Study of Debio 1450 for Bacterial Skin Infections
- Conditions
- Bacterial Infections
- Interventions
- Drug: Debio 1450 IVDrug: Debio 1450 Oral PlaceboDrug: Debio 1450 Oral
- Registration Number
- NCT02426918
- Lead Sponsor
- Debiopharm International SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Debio 1450 320/480 mg Linezolid Placebo 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 160/240 mg Linezolid Placebo 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 160/240 mg Debio 1450 IV 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. Placebo Debio 1450 Oral Placebo After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID. Placebo Vancomycin IV After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID. Debio 1450 320/480 mg Debio 1450 IV 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 320/480 mg Debio 1450 Oral 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 160/240 mg Debio 1450 Oral 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 160/240 mg Debio 1450 Oral Placebo 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. Placebo Linezolid After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.
- Primary Outcome Measures
Name Time Method Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator At 48 to 72 hours from randomization (Day 4) 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
Name Time Method 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) 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.
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) 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.
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) 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 48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19) 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.
Trial Locations
- Locations (22)
Beaumont Infectious Disease Services
🇺🇸Royal Oak, Michigan, United States
Dream Team Clinical Research, LLC
🇺🇸Anaheim, California, United States
eStudySite - Chula Vista
🇺🇸Chula Vista, California, United States
Physician Alliance Research Center
🇺🇸Anaheim, California, United States
eStudySite - La Mesa
🇺🇸La Mesa, California, United States
Southbay Pharma Research
🇺🇸Buena Park, California, United States
Alliance Research
🇺🇸Long Beach, California, United States
eStudySite - Oceanside
🇺🇸Oceanside, California, United States
Olive View - UCLA Medical Center
🇺🇸Sylmar, California, United States
Central Valley Research, LLC
🇺🇸Modesto, California, United States
Triple O Research Institute
🇺🇸West Palm Beach, Florida, United States
Shands Burn Center at the University of Florida
🇺🇸Gainesville, Florida, United States
Central Florida Internists
🇺🇸Orlando, Florida, United States
Columbus Regional Research
🇺🇸Columbus, Georgia, United States
South Jersey Infectious Disease
🇺🇸Somers Point, 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
eStudySite - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Long Beach Clinical Trials LLC
🇺🇸Long Beach, California, United States
Mercury Street Medical Group PLLC
🇺🇸Butte, Montana, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States