Status:
COMPLETED
Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
Lead Sponsor:
Melinta Therapeutics, Inc.
Conditions:
Wound Infection
Abscess
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 methi...
Detailed Description
This was 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- History of immune-related hypersensitivity reaction to glycopeptides
- Participants that required anticoagulant monitoring with an activated partial thromboplastin time
- Contraindication to vancomycin
- Participants 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
- Participants 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2012
Estimated Enrollment :
968 Patients enrolled
Trial Details
Trial ID
NCT01252719
Start Date
December 1 2010
End Date
November 30 2012
Last Update
August 1 2022
Active Locations (1)
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1
Sharp Chula Vista Medical Center
Chula Vista, California, United States, 91911