Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections

Completed · Phase 3

Conditions studied: Acute Bacterial Skin and Skin Structure Infections

In brief

This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections (ABSSSIs).

Key facts

Study ID

NCT03137173

Run by

Basilea Pharmaceutica

People needed

679

Starts

2018-02-19

Expected to finish

2019-04-22

Last updated by the study team

2023-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged ≥18 years.
• Diagnosis of ABSSSI, meeting at least one of the definitions in (a) to (c) below. Local symptoms must have started within the 7 days prior to the Screening visit:
• Cellulitis/erysipelas, defined as a diffuse skin infection characterized by all of the following within 24 hours:
• i. Rapidly spreading areas of erythema, edema, and/or induration with a minimum total lesion surface area of 75cm\^2
• ii. No collection of pus apparent upon visual examination
• iii. At least two of the following local signs of infection:
• erythema
• induration
• localized warmth
• pain or tenderness on palpation
• swelling/edema
• Major cutaneous abscess, defined as infection characterized by a collection of pus within the dermis or deeper that is apparent upon visual examination before or after therapeutic intervention and is accompanied by all of the following within 24 hours:
• i. Erythema, edema and/or induration with a minimum total lesion surface area of 75 cm\^2.
• ii. At least two of the following local signs of infection:
• fluctuance
• incision and drainage required
• purulent or seropurulent drainage
• localized warmth
• pain or tenderness on palpation
• Wound infection, defined as infection of any apparent break in the skin characterized by at least one of the following:
• i. Superficial incision/surgical site infection meeting all of the following criteria:
• involves only the skin or subcutaneous tissue around the incision (does not involve fascia).
• occurs within 30 days of procedure.
• purulent drainage (spontaneous or therapeutic) with surrounding erythema, edema and/ or induration with a minimum total lesion surface area of 75cm\^2.
• ii. Post-traumatic wound (including penetrating trauma, e.g., needle, nail, knife, insect and spider bites) meeting the following criterion within 24 hours:

You may not qualify if…

• Patients meeting any one of the following:
• Use of any systemic antibacterial treatment within 14 days, or topical antibacterial administration on the primary lesion within 96 hours, before first infusion of study drug.
• Exception: Receipt of a single dose of a short acting (half-life ≤ 12 hours) antibacterial therapy (e.g., for surgical prophylaxis) within > 3 days before randomization (i.e., patients cannot have received any antibacterial treatment within 72 hours of randomization).
• Contraindication to the administration of either of the study treatments, including known clinically-relevant hypersensitivity to related antibacterial treatments (e.g., beta-lactam and glycopeptide antibiotics), or to metronidazole if required as adjunctive therapy.
• Participation in any other clinical study within the 30 days prior to randomization, or any prior participation in this study.
• The primary ABSSSI is an uncomplicated skin and skin structure infection, such as furuncles, minor abscesses (area of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, or minor wound infections (e.g., stitch abscesses).
• The primary ABSSSI is due to, or associated with, any of the following:
• Diabetic foot infection, gangrene, or perianal abscess.
• Concomitant infection at another site (e.g., septic arthritis, endocarditis, osteomyelitis), not including a secondary ABSSSI lesion.
• Infected burns.
• Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous).
• Any evolving necrotizing process (e.g., necrotizing fasciitis).
• Infections at vascular catheter sites, or involving thrombophlebitis.
• The primary ABSSSI is associated with, or in close proximity to, a prosthetic device.
• Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI.
• Patients expected to require more than two surgical interventions in the operating room for the ABSSSI.
• Severe sepsis or septic shock.
• Significant or life-threatening condition (e.g., endocarditis, meningitis) that would confound, or interfere with, the assessment of the ABSSSI.
• Another severe, acute or chronic medical condition, psychiatric condition, or laboratory abnormality that may increase the risks associated with study participation or administration of the investigational product, or may interfere with the interpretation of study results, and which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
• Receiving treatment for active tuberculosis.
• Absolute neutrophil count < 0.5 × 10\^9/L.
• Recent history of opportunistic infections (i.e., within 30 days) if the underlying cause of these infections is still active (e.g., leukemia, transplant, acquired immunodeficiency syndrome [AIDS]).
• Patients receiving systemic steroids (> 40 mg per day prednisolone, or equivalent), or receiving immunosuppressant drugs.
• Requirement for peritoneal dialysis, plasmapheresis, hemodialysis, venovenous dialysis, or other forms of renal filtration, or expected to require such treatment before the TOC visit.
• Alanine transaminase (ALT) or aspartate transaminase (AST) levels ≥ 8× the upper limit of normal, OR severe hepatic disease with Child-Pugh class C.

Where it is running

• Physician Alliance Research Center — Anaheim, California, United States
• Saint Joseph's Clinical Research — Anaheim, California, United States
• eStudySite - Chula Vista - PPDS — Chula Vista, California, United States
• Central Valley Research LLC — Fresno, California, United States
• Marvel Clinical Research — Huntington Beach, California, United States
• eStudySite - La Mesa - PPDS — La Mesa, California, United States
• Omnibus Clinical Research — La Palma, California, United States
• Alliance Research LLC — Long Beach, California, United States
• Long Beach Clinical Trials — Long Beach, California, United States
• Central Valley Research, LLC — Modesto, California, United States
• Gonzalez MD and Aswad MD Health Services — Coral Gables, Florida, United States
• L&C Professional Medical Research Institute — Miami, Florida, United States
• Mercury Street Medical Group — Butte, Montana, United States
• eStudySite - Las Vegas - PPDS — Las Vegas, Nevada, United States
• Excel Clinical Research — Las Vegas, Nevada, United States
• South Jersey Infectious Disease — Somers Point, New Jersey, United States
• University Multiprofile Hospital for Active Treatment — Pleven, Bulgaria
• University Multiprofile Hospital for Active Treatment — Plovdiv, Bulgaria
• University Multiprofile Hospital for Active Treatment — Rousse, Bulgaria
• "University Multiprofile Hospital for Active Treatment and Emergency Medicine ""N. I. Pirogov"", Clinic of Purulent-Septic Surgery-"N.I. Pirogov"" — Sofia, Bulgaria
• Kaposi Mor Teaching Hospital — Kaposvár, Hungary
• CRU Hungary Ltd. — Miskolc, Hungary
• University of SzegednAlbert Szent-Gyorgyi Clinical Center — Szeged, Hungary
• Csolnoky Ferenc Hospital — Veszprém, Hungary
• Dnipropetrovsk I.I. Mechnуkov Regional Clinical Hospital, Surgery Department #2 — Dnipro, Ukraine

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.