acute bacterial skin and skin structure infections (abSSSI) MedDRA version: 14.1 Level: LLT Classification code 10004035 Term: Bacterial infection due to staphylococcus aureus System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Dalbavancin
Product Code: DUR001
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: Dalbavancin
CAS Number: 171500-79-1
Current Sponsor code: DUR001
Other d
Sponsors
Durata Therapeutics, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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 from the rim of induration or edema that defines the border of the abscess in all directions, 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 in at least one direction = 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 •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: (a) An elevated body temperature =38 degrees Centigrade/100.4 degrees Fahrenheit 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 556 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 556
Exclusion criteria
Exclusion criteria: Patients presenting with any of the following will be excluded from the study: 1.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.Sustained shock, defined as systolic blood pressure 8 microgram/ml). 7.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 (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen. 9.Venous catheter entry site infection. 10.Infections involving a diabetic foot ulceration, perirectal abscess or a decubitus ulcer. 11.An infected device, even if the device is removed (eg, prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, hemodialysis catheter, implantable pacemaker or defibrillator, intra-aortic balloon pump, left ventricular assist device, a peritoneal dialysis catheter, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter). 12.Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram positive bacteremia. 13.Patient's abSSSI is the result of having sustained full or partial thickness burns. 14.An infection involving a limb with evidence of critical ischemia of an affected limb (ie, 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.Patient's abSSSI (ie, 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.Placement in a hyperbaric chamber as adjunctive therapy for the abSSSI. 19.More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the abSSSI, or patients who are expected to require more than 2 such interventions. 20
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen [vancomycin with the option to switch to oral linezolid (vancomycin/linezolid)] for the treatment of patients with a suspected or proven Gram-positive abSSSI.;Secondary Objective: The secondary objectives of this study are: - To compare the clinical efficacy at the end of treatment visit (EOT) of dalbavancin to the comparator regimen. - To compare the per-patient microbiological efficacy of dalbavancin to the comparator regimen. - To compare clinical efficacy by individual pathogens in the two treatment groups. - To compare pathogen eradication rates for individual pathogens in the two treatment groups. - To compare the safety and tolerability of dalbavancin to that of the comparator regimen.;Primary end point(s): The primary outcome measure is clinical response at 48-72 hours post study drug initiation, as defined programmatically based on measurements of abSSSI lesion size and temperature;Timepoint(s) of evaluation of this end point: 48-72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A secondary outcome is clinical status at the EOT Visit ;Timepoint(s) of evaluation of this end point: study day 14-15 | — |
Countries
Canada, Croatia, Georgia, Germany, Russian Federation, Serbia, Ukraine, United States
Contacts
Public ContactStudy Director
Durata Therapeutics, Inc.
Outcome results
None listed