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

NCT01252732 | Completed Phase 3 Results DMC

• 1 other identifier: TMC-ORI-10-02
• Study Type: interventional
• Target: 1,019
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Infection; Abscess; Systemic Inflammation; Cellulitis

Keywords

ABSSSI; Skin Infection; Abscess

Outcome Measures

Primary Outcomes (1)

• Early Clinical Response

  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.

  48-72 hours after the initation of study therapy

Secondary Outcomes (2)

• Investigator Assessed Clinical Cure at Post Therapy Evaluation (Key Secondary Endpoint)

  7 to 14 days after end of therapy

• >= 20% Reduction in Lesion Area

  48-72 hours after the initation of study therapy

Study Arms (2)

Single-Dose IV Oritavancin Diphosphate

EXPERIMENTAL

Drug: Single-Dose IV Oritavancin Diphosphate

IV Vancomycin

ACTIVE COMPARATOR

Drug: IV Vancomycin

Interventions

Single-Dose IV Oritavancin Diphosphate DRUG

Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.

Single-Dose IV Oritavancin Diphosphate

IV Vancomycin DRUG

Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.

IV Vancomycin

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 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:

• 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

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (1)

Sharp Grossmont Hospital

La Mesa, California, 91942, 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, Good S, Jiang H, Moeck G, Wikler M, Green S, Manos P, Keech R, Singh R, Heller B, Bubnova N, O'Riordan W; SOLO II Investigators. Single-dose oritavancin versus 7-10 days of vancomycin in the treatment of gram-positive acute bacterial skin and skin structure infections: the SOLO II noninferiority study. Clin Infect Dis. 2015 Jan 15;60(2):254-62. doi: 10.1093/cid/ciu778. Epub 2014 Oct 6.

  PMID: 25294250 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: Karen Fusaro
• Organization: Melinta Therapeutics, Inc.

kfusaro@melinta.com

6098270956

Study Officials

• G. Ralph Corey, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 5, 2021
• Results First Posted: April 13, 2021

Record last verified: 2021-04

Locations

US (1)