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

Completed · Phase 3 · Has a placebo group

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

In brief

The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant staphylococcus aureus (MRSA), and to evaluate the potential economic benefit of oritavancin administered as a single 1200-milligram (mg) intravenous (IV) dose.

Key facts

Study ID

NCT01252719

Run by

Melinta Therapeutics, Inc.

People needed

968

Starts

2010-12-01

Expected to finish

2012-11-30

Last updated by the study team

2022-08-01

Who can join

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

You may qualify if…

• Participants were included in the study if they met 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 7 days of IV therapy
• An ABSSSI included 1 of the following infections: wound infections, cellulitis/erysipelas, major cutaneous abscess
• ABSSSI must have presented with at least 2 local signs and symptoms and at least 1 sign of systemic inflammation (unless >70 years of age).
• Able to give informed consent and willing to comply with all required study procedures

You may not qualify if…

• Participants were excluded from the study if any of the following exclusion criteria applied prior to randomization:
• Prior systemic or topical antibacterial therapy with activity against suspected or proven gram-positive pathogens within the preceding 14 days unless:
• The causative gram-positive pathogen(s) isolated from the ABSSSI site was/were resistant in vitro to the antibacterial(s) that was/were administered with documented clinical progression.
• Documented failure to previous ABSSSI antibiotic therapy was available. Documentation of treatment failure must have been recorded.
• Participant received a single dose of a short-acting antibacterial therapy 3 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 minimum inhibitory concentration >2 micrograms/milliliter or clinically failing prior therapy with glycopeptides
• Catheter site infections
• Allergy or intolerance to aztreonam or metronidazole in a participant with suspected or proven polymicrobial wound infection involving gram-negative and/or anaerobic bacteria
• Was currently receiving chronic systemic immunosuppressive therapy
• Acquired immunodeficiency syndrome with cluster of differentiation 4 count <200 cells/cubic millimeter
• Neutropenia
• Significant or life-threatening condition that would confound or interfere with the assessment of the ABSSSI
• Women who were pregnant or nursing

Where it is running

• Sharp Chula Vista Medical Center — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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