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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.

Tracking Information
First Submitted Date  ICMJE December 1, 2010
First Posted Date  ICMJE December 3, 2010
Results First Submitted Date  ICMJE March 17, 2021
Results First Posted Date  ICMJE April 13, 2021
Last Update Posted Date May 5, 2021
Study Start Date  ICMJE December 2010
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2010)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2021)
  • 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
  • >= 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2010)
  • Clinical cure determined by the investigator at the EOT, Day 10, and PTE visits [ Time Frame: To be determined by the investigator at end of therapy, Day 10, and post therapy evaluation visits ]
  • The clinical cure determined by the investigator, overall, and by pathogen, at the EOT visit, Day 10, and at the PTE visit [ Time Frame: To be determined by the investigator, at end of therapy visit, Day 10, and post therapy evaluation ]
  • 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: During the designated study period ]
  • 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 ]
  • The microbiological response, overall and by pathogen, at the EOT visit, at Day 10, and at the PTE visit [ Time Frame: At the EOT visit, at Day 10, and at the PTE visit ]
  • The microbiological relapse (or recurrence) at the PTE visit [ Time Frame: At the PTE visit ]
  • 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: At screeing to PTE ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection
Official Title  ICMJE 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)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Wound Infection
  • Abscess
  • Systemic Inflammation
  • Cellulitis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Single-Dose IV Oritavancin Diphosphate
    Intervention: Drug: Single-Dose IV Oritavancin Diphosphate
  • Active Comparator: IV Vancomycin
    Intervention: Drug: IV Vancomycin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2013)
1019
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2010)
960
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01252732
Other Study ID Numbers  ICMJE TMC-ORI-10-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melinta Therapeutics, Inc.
Study Sponsor  ICMJE Melinta Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: G. Ralph Corey, MD Duke Clinical Research Institute
PRS Account Melinta Therapeutics, Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP