Abscess | Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Abscess research study
What is the primary objective of this study?
To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in patients with known or suspected Gram-positive abSSSI (acute bacterial skin and skin structure infections) at 48 -72 hours after initiation of treatment.
Who is eligible to participate?
Inclusion Criteria: - Male or female patients 18 - 85 years of age. - Signed and dated informed consent document. - Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria. - At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign of infection. - Patient willing and able to comply with study procedures. Exclusion Criteria: - A contra-indication to dalbavancin - Pregnant or nursing females. - Sustained shock. - Participation in another study of an investigational drug or device within 30 days. - 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 prior to randomization; up to 25% of subjects may have received such therapy. - Infection due to an organism known prior to study entry to be resistant to dalbavancin or vancomycin (vancomycin MIC (minimum inhibitory concentration) >8 μg/mL). - 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. - 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. - Venous catheter entry site infection. - Infections involving a diabetic foot ulceration, perirectal abscess or a decubitus ulcer. - Patient with an infected device, even if the device is removed. Examples include infection of: 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. - Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the study, or is subsequently found to have been present at Baseline, the patient should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia. Such patients must have an EOT visit performed within 3 calendar days after discontinuing study medication but are required to have AEs (adverse events) reported through the Final Visit. - Patients whose abSSSI is the result of having sustained full or partial thickness burns. - 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. - Patients with abSSSI such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure. - Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study. - Anticipated need of antibiotic therapy for longer than 14 days. - Patients who are placed in a hyperbaric chamber as adjunctive therapy for the abSSSI. - 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. - Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity). - Absolute neutrophil count <500 cells/mm3. - Known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 (cluster of differentiation 4) cell count <200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count. - Patients with a recent bone marrow transplant (in post-transplant hospital stay). - Patients receiving oral steroids >20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation. - Patients with a rapidly fatal illness, who are not expected to survive for 3 months. - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. - Prior participation in this study.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Surgical Site Infection
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Single Dose DalbavancinSingle dose of dalbavancin 1500 mg on day 1
Drug:Two Dose DalbavancinTwo dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Single Dose DalbavancinSingle dose of dalbavancin 1500 mg on day 1
Two Dose DalbavancinTwo dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8)
Start Date: April 2014
Completed Date: March 2015
Phase: Phase 3
Primary Outcome: Clinical Response
Secondary Outcome: Clinical Status at Final Visit (Day 28 +/- 2 days)
Study sponsors, principal investigator, and references
Principal Investigator: Michael Dunne, MD
Lead Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc