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

Completed · Phase 3 · Has a placebo group

Conditions studied: Wound Infection, Abscess, Systemic Inflammation, Cellulitis

In brief

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.

Key facts

Study ID

NCT01252732

Run by

Melinta Therapeutics, Inc.

People needed

1019

Starts

2010-12-01

Expected to finish

2013-06-01

Last updated by the study team

2021-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sharp Grossmont Hospital — La Mesa, California, United States

Full record on ClinicalTrials.gov

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