Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection

NCT02925416 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MDCO-ORI-16-02
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the safety and tolerability of two 1200 milligram (mg) intravenous (IV) infusions of oritavancin when administered one week apart.

Conditions

Skin Diseases, Bacterial

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment, including abnormal vital signs or laboratory assessments. Treatment emergent adverse events (TEAE) were AEs which occurred or whose severities worsened on or after the initiation of study drug. An SAE was defined as any untoward medical occurrence that at any dose resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  Up to Day 21 after first administration of oritavancin

Secondary Outcomes (1)

• Number of Participants With a Clinical Response of Cure

  Up to Day 8 after first administration of oritavancin

Study Arms (2)

Oritavancin/Oritavancin

EXPERIMENTAL

On Day 1, participants were administered a single 1200-mg IV dose of oritavancin in 1000 milliliters (mL) diluted in 5% dextrose in water (D5W). On Day 7, an additional 1200-mg IV dose of oritavancin in 1000 mL of D5W was administered.

Drug: Oritavancin

Oritavancin/Placebo

OTHER

On Day 1, participants were administered a single 1200-mg IV dose of oritavancin in 1000 mL of D5W. On Day 7, a placebo was administered IV in 1000 mL of D5W.

Drug: Oritavancin; Drug: Placebo (D5W)

Interventions

Oritavancin DRUG

Administered intravenously

Also known as: Orbactiv

Oritavancin/Oritavancin; Oritavancin/Placebo

Placebo (D5W) DRUG

Administered intravenously

Oritavancin/Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of ABSSSI (wound infections, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy
• Able to give informed consent and willing to comply with all required study procedures

You may not qualify if:

• 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 (i.e., human or animal bites, injuries contaminated with fresh or salt water, external malignant otitis)
• Wound infections (surgical or traumatic) and abscesses with only Gram-negative pathogens
• Diabetic foot infections (infection extending distal to the malleoli in a participant with diabetes mellitus and peripheral neuropathy and/or vascular insufficiency or any ulceration of their foot)
• Concomitant infection at another site not including a secondary ABSSSI lesion (e.g., septic arthritis, endocarditis, osteomyelitis)
• Infected burns
• A primary infection secondary to a pre-existing skin disease with associated inflammatory changes such as atopic dermatitis, eczema, or hidradenitis suppurativa
• Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous)
• Any evolving necrotizing process (i.e., necrotizing fasciitis), gangrene, or infection suspected or proven to be caused by Clostridium species (e.g., crepitance on examination of the ABSSSI site and/or surrounding tissue(s) or radiographic evidence of subcutaneous gas in proximity to the infection)
• Infections known to be caused by a Gram-positive organism with a vancomycin minimum inhibitory concentration (MIC) \>2 μg/mL or clinically failing prior therapy with glycopeptides
• Catheter site infections
• Currently receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone (prednisone at non-immunosuppressive doses of ≤15 mg/day is permitted)

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (1)

South Jersey Infectious Disease

Somers Point, New Jersey, 08244, United States

Location

MeSH Terms

Conditions

Skin Diseases, Bacterial

Interventions

oritavancin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Melinta Therapeutics

medinfo@melinta.com

1-844-633-6568

Study Officials

• Medical Information

  Melinta Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 5, 2016
• Study Start: January 24, 2017
• Primary Completion: June 20, 2017
• Study Completion: June 20, 2017
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)