A study to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of skin and nearby tissue infections.

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; Acute bacterial skin and skin structure infections; MedDRA version: 20.1 Level: PT Classification code 10052891 Term: Skin bacterial infection System Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2017-001605-32-BG
• Lead Sponsor: Basilea Pharmaceutica International Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 674

Inclusion Criteria

Patients meeting all of the following:
1. Male or female, aged = 18 years.
2. 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.
(a) Cellulitis/erysipelas, defined as a diffuse skin infection characterized by all of the following within 24 h:
i. Rapidly spreading areas of erythema, edema, and/or induration with a minimum total lesion surface area of 75 cm2.
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
(b) 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 h:
i. Erythema, edema and/or induration with a minimum total lesion surface area of 75 cm2.
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
(c) 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 75 cm2.
ii. Post-traumatic wound (including penetrating trauma, e.g., needle, nail, knife, insect and spider bites) meeting the following criterion within 24 h:
? Purulent drainage (spontaneous or therapeutic) with surrounding erythema, edema and/or induration with a minimum total lesion surface area of 75 cm2.
3. At least one of the following regional or systemic signs of infection at the Screening visit:
(a) Lymph node tenderness and volume increase, or palpable lymph node proximal to the primary ABSSSI.
(b) Fever = 38°C/100.4°F measured orally, > 38.5 °C / 101.3 °F measured tympanically, , 37.5 °C /99.5 °F measured by the axillary method, or > 39 °C / 102.2 °F measured rectally.
(c) White blood cell (WBC) count > 10.0 × 109/L or < 4.0 × 109/L.
(d) > 10% immature neutrophils (band forms).
4. Requirement for intravenous (IV) antibacterial treatment.
5. Willing and able to adhere to study procedures (including prohibitions and restrictions) as specified in this protocol.
6. Willing and able to remain hospitalized (in a hospital or equivalent medical confinement or clinical research unit) until completion of the early-clinical-response assessment for the primary endpoint.

Exclusion Criteria

Patients meeting any one of the following:
1. Use of any systemic antibacterial treatment within 14 days, or topical antibacterial administration on the primary lesion within 96 h, before first infusion of study drug.
Exception: Receipt of a single dose of a short-acting (half-life = 12 h) antibacterial therapy (e.g., for surgical prophylaxis) within > 3 days before randomization (i.e., patients cannot have received any antibacterial treatment within 72 h of randomization).
2. 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.
3. Participation in any other clinical study within the 30 days prior to randomization, or any prior participation in this study.
4. 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).
5. The primary ABSSSI is due to, or associated with, any of the following:
(a) Diabetic foot infection, gangrene, or perianal abscess.
(b) Concomitant infection at another site (e.g., septic arthritis, endocarditis, osteomyelitis), not including a secondary ABSSSI lesion.
(c) Infected burns.
(d) Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous).
(e) Any evolving necrotizing process (e.g., necrotizing fasciitis).
(f) Infections at vascular catheter sites, or involving thrombophlebitis.
6. The primary ABSSSI is associated with, or in close proximity to, a prosthetic device.
7. Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI.
8. Patients expected to require more than two surgical interventions in the operating room for the ABSSSI.
9. Severe sepsis or septic shock.
10. Significant or life-threatening condition (e.g., endocarditis, meningitis) that would confound, or interfere with, the assessment of the ABSSSI.
11. 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.
12. Receiving treatment for active tuberculosis.
13. Absolute neutrophil count < 0.5 × 109/L.
14. 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]).
15. Patients receiving systemic steroids (> 40 mg per day prednisolone, or equivalent), or receiving immunosuppressant drugs.
16. Requirement for peritoneal dialysis, plasmapheresis, hemodialysis, venovenous dialysi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified