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

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ClinicalTrials.gov Identifier: NCT01252732
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : April 13, 2021
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Wound Infection Abscess Systemic Inflammation Cellulitis Drug: Single-Dose IV Oritavancin Diphosphate Drug: IV Vancomycin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1019 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : December 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Early Clinical Response [ Time Frame: 48-72 hours after the initation of study therapy ]
    Clinical response at the ECE visit (48-72 hours following initiation of study drug administration). Early clinical response was defined as a composite outcome based on, cessation of spreading or reduction in the size of baseline lesion, absence of fever and no rescue antibiotic medication.


Secondary Outcome Measures :
  1. Investigator Assessed Clinical Cure at Post Therapy Evaluation (Key Secondary Endpoint) [ Time Frame: 7 to 14 days after end of therapy ]
    Compared the clinical efficacy at the Post Therapy Evaluation of Oritavancin and Vancomycin based on the Investigator examination of the signs and symptoms of the primary ABSSSI; Investigator assessment of clinical cure is complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics is needed

  2. >= 20% Reduction in Lesion Area [ Time Frame: 48-72 hours after the initation of study therapy ]
    Clinical response at the ECE visit (48-72 hours following initiation of study drug administration) based on changes in ABSSSI lesion size measurements from baseline.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01252732


Locations
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United States, California
Sharp Grossmont Hospital
La Mesa, California, United States, 91942
Sponsors and Collaborators
Melinta Therapeutics, Inc.
Investigators
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Principal Investigator: G. Ralph Corey, MD Duke Clinical Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01252732    
Other Study ID Numbers: TMC-ORI-10-02
First Posted: December 3, 2010    Key Record Dates
Results First Posted: April 13, 2021
Last Update Posted: May 5, 2021
Last Verified: April 2021
Keywords provided by Melinta Therapeutics, Inc.:
ABSSSI
Skin Infection
Abscess
Additional relevant MeSH terms:
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Oritavancin
Infections
Communicable Diseases
Wound Infection
Abscess
Cellulitis
Inflammation
Disease Attributes
Pathologic Processes
Suppuration
Skin Diseases, Infectious
Connective Tissue Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents