A research study of the investigational antibiotic dalbavancin compared to a standard antibiotic for the treatment of infections of the skin and nearby tissues.

• Conditions: acute bacterial skin and skin structure infections (abSSSI); MedDRA version: 14.1Level: LLTClassification code 10004035Term: Bacterial infection due to staphylococcus aureusSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-002130-40-HU
• Lead Sponsor: Durata Therapeutics, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-26
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

1. Male or female patients 18 - 85 years of age.
2. A personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
3. Patients having an abSSSI (suspected or confirmed to be caused by Gram-positive bacteria) defined for purposes of this study as an infection either involving deeper soft tissue or requiring significant surgical intervention:
(a) Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which:
i. requires surgical incision and drainage, and
ii. is associated with cellulitis such that the total affected area involves at least 75 cm2 of erythema, and
iii. is defined by a margin of erythema that is = 5 cm in all directions from the rim of induration or edema that defines the border of the abscess, or,
iv. alternatively, involves the central face and is associated with an area of erythema of at least 50 cm2 and a margin = 3 cm in all directions from the abscess rim.
(b) Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that
i. the total affected area involves at least 75 cm2 of erythema, and
ii. is defined by a margin of erythema in at least one direction that is = 5 cm from the edge of the wound, or
iii. alternatively, involves the central face and is associated with an affected area of at least 50 cm2 and has a margin of erythema = 3 cm from the wound edge.
(c) Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and
i. is associated with erythema that involves at least 75 cm2 of surface area, or
ii. alternatively, cellulitis of the central face that is associated with an affected area of at least 50 cm2
4. In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of abSSSI
English protocol synopsis version 2.0 dated 24October2011 based on Protocol Amendment 2, dated
19Oct2011
6/12
• Purulent drainage/discharge
• Fluctuance
• Heat/localized warmth
• Tenderness to palpation
• Swelling/induration
5. Patients must present with at least ONE of the following systemic signs of infection:
1. (a) An elevated body temperature = 38°C/100.4°F as measured by the patient/caregiver or investigator within 24 hours of baseline;
(b) White blood cell count > 12,000 cells/mm3;
(c) A manually performed white blood differential count with = 10% band forms, regardless of peripheral white blood cell count.
6. Infection severity such that a minimum of 3 days of IV therapy is appropriate for management of the abSSSI.
7. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 592
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 148

Exclusion Criteria

Patients presenting with any of the following will not be included in the study:
1. Patients with a contra-indication to the administration of dalbavancin, vancomycin, or linezolid such as hypersensitivity to any of the agents.
2. Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant.
3. Patients with sustained shock, defined as systolic blood pressure < 90 mm Hg for more than 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
4. Participation in another study of an investigational drug or device within 30 days before this study begins.
5. Receipt of a systemically or topically administered antibiotic with a gram positive spectrum that achieves therapeutic concentrations in the serum or at the site of the abSSSI within 14 days prior to randomization. An exception is allowed for patients receiving a single dose of a short-acting (half-life = 12 hours) antibacterial drug 3 or more days prior to randomization (e.g., administration of a single dose of an antibacterial drug for surgical prophylaxis).
6. Infection due to an organism known prior to study entry to be resistant dalvabacin or vancomycin.
7. Patients with evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis; endovascular infection, such as clinical and/or echocardiographic evidence of endocarditis or septic thrombophlebitis.
8. Infections caused exclusively by Gram-negative bacteria 9. Venous catheter entry site infection.
10. Infections involving a diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
11. Patient with an infected device, even if the device is removed
12. Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia.
13. Patients whose abSSSI is the result of having sustained full or partial thickness burns.
14. Patients with an infection involving a limb with evidence of critical ischemia of an affected limb defined as any of the following criteria: absent or abnormal Doppler wave forms, toe blood pressure of < 45 mm Hg, ankle brachial index < 0.5, and/ or critical ischemia as assessed by a vascular surgeon.
15. Patients with abSSSI such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure.
16. Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study.
17. Anticipated need of antibiotic therapy for longer than 14 days.
18. Patients who are placed in a hyperbaric chamber as adjunctive therapy for the abSSSI.
19. More than 2 surgical interventions. .
20. Medical conditions in which chronic inflammation may preclude assessment ofclinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity).
21. Absolute neutrophil count < 500 cells/mm3.
22. Known or suspected human immunodeficiency virus (HIV) infected patients .
23. Patients with a recent bone marrow transplant (in post-transplant hospital stay).
24. Patients receiving oral steroids > 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
25. Patients

Study & Design

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