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Trial record 3 of 16 for:    dalbavancin

Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02127970
First Posted: May 1, 2014
Last Update Posted: June 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Durata Therapeutics Inc., an affiliate of Allergan plc
  Purpose
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.

Condition Intervention Phase
Abscess Wound Infection Surgical Site Infection Cellulitis Drug: Single Dose Dalbavancin Drug: Two Dose Dalbavancin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b, Double-Blind, Multicenter, Randomized Study to Compare the Efficacy and Safety of Single Dose Dalbavancin to a Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Resource links provided by NLM:


Further study details as provided by Durata Therapeutics Inc., an affiliate of Allergan plc:

Primary Outcome Measures:
  • Clinical Response [ Time Frame: 48-72 hours after the initiation of study therapy ]
    Based on a decrease of ≥20% in lesion area


Secondary Outcome Measures:
  • Clinical Status at Final Visit (Day 28 +/- 2 days) [ Time Frame: Day 28 (+/- 2 days) after the initiation of study therapy ]
    Based on several criteria including a decrease in lesion size of ≥ 90%


Other Outcome Measures:
  • Clinical Status at End of Treatment (EOT - Day 14-15) [ Time Frame: EOT (Day 14-15) ]
    Defined as warmth/fluctuance must be improved and no worse than mild

  • Investigator Assessment of Clinical Outcome [ Time Frame: Day 3-4, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days) ]
    Based on resolution or improvement of all signs and symptoms of the infection to such an extent that no further antibacterial treatment was given

  • Proportion of patients achieving clinical outcome of success based on baseline pathogen [ Time Frame: Day 3-4 and EOT (Day 14-15) ]
  • Resolution of local signs of infection [ Time Frame: Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days) ]
  • Patient's assessment of pain [ Time Frame: Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days) ]
  • Resource utilization, including days in hospital, outpatient, and emergency department visits and need for tests or procedures [ Time Frame: Final Visit (Day 28 +/- 2 days) ]
  • Skin and Soft Tissue Infection - Convenience (SSTI-C) questionnaire - self reported questionnaire that measures subjective experiences of the patient [ Time Frame: EOT (Day 14-15) ]

Enrollment: 698
Study Start Date: April 2014
Study Completion Date: March 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Dose Dalbavancin
Single dose of dalbavancin 1500 mg on day 1
Drug: Single Dose Dalbavancin
Single dose of dalbavancin 1500 mg on day 1
Other Name: Dalvance(TM)
Experimental: Two Dose Dalbavancin
Two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8)
Drug: Two Dose Dalbavancin
Two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8)
Other Name: Dalvance(TM)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127970


  Show 78 Study Locations
Sponsors and Collaborators
Durata Therapeutics Inc., an affiliate of Allergan plc
Investigators
Study Director: Michael Dunne, MD Durata Therapeutics
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Durata Therapeutics Inc., an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT02127970     History of Changes
Other Study ID Numbers: DUR001-303
First Submitted: April 25, 2014
First Posted: May 1, 2014
Last Update Posted: June 2, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Dalbavancin
Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Cellulitis
Postoperative Complications
Pathologic Processes
Skin Diseases, Infectious
Suppuration
Connective Tissue Diseases
Inflammation
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents