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

NCT01252719 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: TMC-ORI-10-01
• Study Type: interventional
• Target: 968
• Locations: 1 country
• Sites: 1

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 methicillin-resistant staphylococcus aureus (MRSA), and to evaluate the potential economic benefit of oritavancin administered as a single 1200-milligram (mg) intravenous (IV) dose.

Conditions

Wound Infection; Abscess; Systemic Inflammation; Cellulitis

Keywords

ABSSSI; Skin Infection; Abscess

Outcome Measures

Primary Outcomes (1)

• Cessation Of Spread Or Reduction In Size Of Baseline Lesion, Absence Of Fever, And No Rescue Antibiotic Medication At Early Clinical Evaluation (ECE) (48 To 72 Hours)

  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. A participant was classified as "success" if all of the following were met: cessation of spread or reduction of the lesion (defined as cessation of spread of the redness, edema, and/or induration or reduction in size \[length, width, and area\] of the redness, edema, and/or induration such that the size of the lesion was less than or equal to the size at baseline); resolution (absence) of fever (temperature \<37.7°Celsius at the last 3 consecutive recordings by the same route of administration taken 4 times per day, for example every 6 hours between 48 and 72 hours); no rescue antibiotic medication.

  48-72 hours after the initiation of study therapy

Secondary Outcomes (2)

• Investigator Assessed Clinical Cure Of Treatment With Single-dose IV Oritavancin Compared With IV Vancomycin For 7 To 10 Days At Post-therapy Evaluation (Key Secondary Endpoint)

  7-14 days after end of therapy

• Number Of Participants With A Lesion Size Reduction ≥20% From Baseline At ECE

  48-72 hours after the initiation of study therapy

Study Arms (2)

Single-Dose IV Oritavancin Diphosphate

EXPERIMENTAL

Drug: Single-Dose IV Oritavancin Diphosphate; Drug: Placebo

IV Vancomycin

ACTIVE COMPARATOR

Drug: IV Vancomycin

Interventions

Single-Dose IV Oritavancin Diphosphate DRUG

Oritavancin was administered as a single IV dose.

Single-Dose IV Oritavancin Diphosphate

IV Vancomycin DRUG

Intravenous vancomycin was administered for a minimum of 7 days and up to a maximum of 10 days.

IV Vancomycin

Placebo DRUG

Intravenous placebo was administered thereafter, for a minimum of 7 days and up to a maximum of 10 days (oritavancin and placebo).

Single-Dose IV Oritavancin Diphosphate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (1)

Sharp Chula Vista Medical Center

Chula Vista, California, 91911, United States

Location

Related Publications (3)

• Corey GR, Loutit J, Moeck G, Wikler M, Dudley MN, O'Riordan W; SOLO I and SOLO II investigators. Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e01919-17. doi: 10.1128/AAC.01919-17. Print 2018 Apr.

  PMID: 29358292 DERIVED

• Deck DH, Jordan JM, Holland TL, Fan W, Wikler MA, Sulham KA, Ralph Corey G. Single-Dose Oritavancin Treatment of Acute Bacterial Skin and Skin Structure Infections: SOLO Trial Efficacy by Eron Severity and Management Setting. Infect Dis Ther. 2016 Sep;5(3):353-61. doi: 10.1007/s40121-016-0119-9. Epub 2016 Jul 1.

  PMID: 27370913 DERIVED

• Corey GR, Kabler H, Mehra P, Gupta S, Overcash JS, Porwal A, Giordano P, Lucasti C, Perez A, Good S, Jiang H, Moeck G, O'Riordan W; SOLO I Investigators. Single-dose oritavancin in the treatment of acute bacterial skin infections. N Engl J Med. 2014 Jun 5;370(23):2180-90. doi: 10.1056/NEJMoa1310422.

  PMID: 24897083 DERIVED

MeSH Terms

Conditions

Wound Infection; Abscess; Cellulitis

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Infections; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Infectious; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Medical Information
• Organization: Melinta Therapeutics, LLC

medinfo@melinta.com

1-844-633-6568

Study Officials

• G. Ralph Corey, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: November 30, 2012
• Last Updated: August 1, 2022
• Results First Posted: August 1, 2022

Record last verified: 2022-07

Locations

US (1)