Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (SOLO II)
This study is ongoing, but not recruiting participants.
Sponsor:
The Medicines Company
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01252732
First received: December 1, 2010
Last updated: April 16, 2013
Last verified: April 2013
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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 ]
| Estimated Enrollment: | 960 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated 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:
- Males or females ≥18 years old
- Diagnosis of ABSSSI suspected or confirmed to be caused by a Gram-positive pathogen requiring at least 5 days of IV therapy
- An ABSSSI includes one of the following infections Wound infections, Cellulitis/erysipelas, Major cutaneous abscess
- ABSSSI must present with at least 2 signs and symptoms
- 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:
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
- Infections associated with, or in close proximity to, a prosthetic device
- Severe sepsis or refractory shock
- Known or suspected bacteremia at time of screening
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
- Allergy or intolerance to aztreonam or metronidazole in a patient with suspected or proven polymicrobial wound infection involving Gram-negative and/or anaerobic bacteria
- Currently receiving chronic systemic immunosuppressive therapy
- AIDS with CD4 count < 200 cells/mm3
- Neutropenia
- Significant or life-threatening condition that would confound or interfere with the assessment of the ABSSSI
- Women who are pregnant or nursing
- History of immune-related hypersensitivity reaction to glycopeptides
- Patients that require anticoagulant monitoring with an aPTT
- Contraindication to vancomycin
- Patients unwilling to forego blood and/or blood product donation
- Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study
- Investigational device present, or removed <30 days before enrollment, or presence of device-related infection
- Patients unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study
- Severe hepatic disease
- Presence of hyperuricemia
- Unwilling to refrain from chronic use of any medication with antipyretic properties
Contacts and Locations
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: | April 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The Medicines Company:
|
ABSSSI Skin Infection Abscess |
Additional relevant MeSH terms:
|
Abscess Cellulitis Inflammation Wound Infection Suppuration Infection Pathologic Processes Skin Diseases, Infectious |
Connective Tissue Diseases Wounds and Injuries Vancomycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013