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Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (SOLO II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01252732
First received: December 1, 2010
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic benefit of oritavancin administered as a single 1200 mg IV dose.


Condition Intervention Phase
Wound Infection
Abscess
Systemic Inflammation
Cellulitis
Drug: Single-Dose IV Oritavancin Diphosphate
Drug: IV Vancomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (SOLO II)

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • Cessation of spread or reduction in size of baseline lesion, absence of fever, and no rescue antibiotic medication at ECE (48 to 72 hours) [ Time Frame: At early clinical evaluation 48 to 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical cure determined by the investigator at the EOT, Day 10, and PTE visits [ Time Frame: 7 to 14 days after end of therapy ] [ Designated as safety issue: No ]
  • The clinical cure determined by the investigator, overall, and by pathogen, at the EOT visit, Day 10, and at the PTE visit [ Time Frame: 7 to 14 days after end of therapy ] [ Designated as safety issue: No ]
  • Safety of oritavancin assessed according to vital signs, laboratory abnormalities, ECG, all-cause mortality and the incidence of adverse events (AEs) and SAEs [ Time Frame: 60 Days from Start of Therapy ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of oritavancin including area under the plasma concentration-time curve (AUC), half-life (t1/2), clearance (CL), Cmax, and steady state volume of distribution (Vss) [ Time Frame: Day 1 through Day 24 ] [ Designated as safety issue: No ]
  • The microbiological response, overall and by pathogen, at the EOT visit, at Day 10, and at the PTE visit [ Time Frame: 7 to 14 days after end of therapy ] [ Designated as safety issue: No ]
  • The microbiological relapse (or recurrence) at the PTE visit [ Time Frame: 7 to 14 days after end of therapy ] [ Designated as safety issue: No ]
  • Clinical response cessation of spread or reduction in size of baseline lesion, absence of fever & no rescue antibiotic medication & clinical cure & microbiological response within the CE population & MicroE population meeting SIRS criteria at screening. [ Time Frame: Start of study drug through 7 to 14 days after end of therapy ] [ Designated as safety issue: No ]

Enrollment: 1019
Study Start Date: December 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single-Dose IV Oritavancin Diphosphate Drug: Single-Dose IV Oritavancin Diphosphate
Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.
Active Comparator: IV Vancomycin Drug: IV Vancomycin
Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.

Detailed Description:

This is a Phase 3, multicenter, randomized, double-blind, parallel, comparative efficacy and safety study of single-dose IV oritavancin/IV placebo versus IV vancomycin for 7 to 10 days in adults with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. Approximately 960 patients will be randomized at 100 centers globally.

In addition, this study will characterize the PK and PK/PD properties of a single 1200 mg IV dose of oritavancin and evaluate the potential health economic benefits offered by this dosing strategy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects may be included in the study if they meet all of the following inclusion criteria:

  1. Males or females ≥18 years old
  2. Diagnosis of ABSSSI suspected or confirmed to be caused by a Gram-positive pathogen requiring at least 5 days of IV therapy
  3. An ABSSSI includes one of the following infections Wound infections, Cellulitis/erysipelas, Major cutaneous abscess
  4. ABSSSI must present with at least 2 signs and symptoms
  5. Able to give informed consent and willing to comply with all required study procedures

Exclusion Criteria:

Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:

  1. Prior systemic or topical antibacterial therapy with activity against suspected or proven Gram-positive pathogens within the preceding 14 days

    • The causative Gram-positive pathogen(s) isolated from the ABSSSI site is resistant in vitro to the antibacterial(s) that was administered with documented clinical progression, or
    • Documented failure to previous ABSSSI antibiotic therapy is available. Documentation of treatment failure must be recorded
    • Patient received a single dose of a short acting antibacterial therapy three or more days before randomization
  2. Infections associated with, or in close proximity to, a prosthetic device
  3. Severe sepsis or refractory shock
  4. Known or suspected bacteremia at time of screening
  5. ABSSSI due to or associated with any of the following:

    • Infections suspected or documented to be caused by Gram-negative pathogens -- Wound infections (surgical or traumatic) and abscesses with only Gram-negative pathogens
    • Diabetic foot infections
    • Concomitant infection at another site not including a secondary ABSSSI lesion
    • Infected burns
    • A primary infection secondary to a pre-existing skin disease with associated inflammatory changes
    • Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease
    • Any evolving necrotizing process gangrene or infection suspected or proven to be caused by Clostridium species
    • Infections known to be caused by a Gram-positive organism with a vancomycin MIC >2 μg/mL or clinically failing prior therapy with glycopeptides
    • Catheter site infections
  6. Allergy or intolerance to aztreonam or metronidazole in a patient with suspected or proven polymicrobial wound infection involving Gram-negative and/or anaerobic bacteria
  7. Currently receiving chronic systemic immunosuppressive therapy
  8. AIDS with CD4 count < 200 cells/mm3
  9. Neutropenia
  10. Significant or life-threatening condition that would confound or interfere with the assessment of the ABSSSI
  11. Women who are pregnant or nursing
  12. History of immune-related hypersensitivity reaction to glycopeptides
  13. Patients that require anticoagulant monitoring with an aPTT
  14. Contraindication to vancomycin
  15. Patients unwilling to forego blood and/or blood product donation
  16. Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study
  17. Investigational device present, or removed <30 days before enrollment, or presence of device-related infection
  18. Patients unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study
  19. Severe hepatic disease
  20. Presence of hyperuricemia
  21. Unwilling to refrain from chronic use of any medication with antipyretic properties
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252732

Locations
United States, California
Sharp Grossmont Hospital
La Mesa, California, United States, 91942
Sponsors and Collaborators
The Medicines Company
Investigators
Principal Investigator: G. Ralph Corey, MD Duke Clinical Research Institute
  More Information

No publications provided

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01252732     History of Changes
Other Study ID Numbers: TMC-ORI-10-02
Study First Received: December 1, 2010
Last Updated: June 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
ABSSSI
Skin Infection
Abscess

Additional relevant MeSH terms:
Cellulitis
Communicable Diseases
Infection
Inflammation
Wound Infection
Connective Tissue Diseases
Pathologic Processes
Skin Diseases, Infectious
Suppuration
Wounds and Injuries
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014