Study of Debio 1450 for Bacterial Skin Infections

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426918
• Other study ID #: Debio 1450-ABSSSI-201
• Secondary ID: 218187
• Status: Completed
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2019
• Source: Debiopharm International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	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	Mercury Street Medical Group PLLC	Butte	Montana
United States	eStudySite - Chula Vista	Chula Vista	California
United States	Columbus Regional Research	Columbus	Georgia
United States	Shands Burn Center at the University of Florida	Gainesville	Florida
United States	East Montgomery County Clinic	Houston	Texas
United States	eStudySite - La Mesa	La Mesa	California
United States	eStudySite - Las Vegas	Las Vegas	Nevada
United States	Alliance Research	Long Beach	California
United States	Long Beach Clinical Trials LLC	Long Beach	California
United States	Central Valley Research, LLC	Modesto	California
United States	eStudySite - Oceanside	Oceanside	California
United States	Central Florida Internists	Orlando	Florida
United States	Beaumont Infectious Disease Services	Royal Oak	Michigan
United States	South Jersey Infectious Disease	Somers Point	New Jersey
United States	Tidwell Medical Center	Splendora	Texas
United States	Olive View - UCLA Medical Center	Sylmar	California
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	ID Clinical Research, Ltd.	Toledo	Ohio
United States	Triple O Research Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Debiopharm International SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)
Secondary	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.	EOT (Day 12) and STFU (Day 19)
Secondary	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).	48 to 72 hours after randomization (Day 4) and STFU (Day 19)
Secondary	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.	48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)