Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections

Melinta Therapeutics

Status and phase: Completed; Phase 2

Conditions: Streptococcal Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections; Infectious Skin Diseases; Abscess

Treatments: Drug: Linezolid; Drug: Radezolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646958

RX-1741-202

Details and patient eligibility

About

The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated skin and skin structure infections

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with uSSSI
• Adult (men and women) ≥18 years
• Females must be post-menopausal for at least 1 year or surgically sterile
• Sexually active males must use a barrier method of birth control during and for 30 days after the study
• Acceptable clinical diagnoses of uSSSI include, but are not limited to: Simple abscess, Impetiginous lesions, Folliculitis, Furunculosis, Carbuncles, Cellulitis
• The infection is accompanied by 2 or more of the following local signs and symptoms: Pain/tenderness, Swelling, Erythema, Localized warmth, Purulent drainage/discharge, Induration, Regional lymph node swelling or tenderness, Extension of redness
• A sample for microbiologic culture must be obtained from the primary infection site at the screening visit
• The patient must require and be a suitable candidate for oral antibiotic therapy in the opinion of the Investigator and be able to swallow tablets or capsules intact
• A written, voluntarily signed informed consent must be obtained from the patient prior to the initiation of any study-related procedures

Exclusion criteria

• Cellulitis (area greater than 10cm2), chronic or recurrent furunculosis, postoperative wound infection, leg ulcer, decubitus ulcer(s), erysipelas, progressive lymphangitis, acute paronychia or a deep tissue abscess such as pilonidal or breast abscess. Also excluded are skin infections resulting from animal bites
• Patients with a complicated skin and skin structure infection as judged by the Investigator
• Infections that can be treated by surgical incision alone according to the judgment of the Investigator
• Treatment with the following anti-infective agents prior to study drug administration: systemic antibiotic within 7 days; azithromycin within 14 days; a long-acting injectable antibiotic within 30 days
• Any infection which requires the use of a concomitant antimicrobial agent, in addition to study drug
• Concomitant topical therapy at the infection site for the period within 48 hours prior to study drug administration through TOC
• A chronic or underlying skin condition at the site of infection or infections involving prosthetic materials
• A wound secondary to burn injury or acne vulgaris
• Any infection site that requires: intraoperative surgical debridement; excision of infected area
• Documented or suspected bacteremia
• Fungal infection involving the nail bed or scalp at the primary uSSSI site
• Significant peripheral vascular disease
• An abscess at an anatomical location where the incidence of anaerobic pathogen involvement is increased
• Patient receiving a daily dose of > 15 mg of systemic prednisone or equivalent, for > 10 days within the period starting 14 days prior to study drug administration or anticipated through TOC
• Patient with known human immunodeficiency virus (HIV) infection.
• Medical history of hypersensitivity or allergic reaction to linezolid according to the judgment of the Investigator
• Patients receiving serotonergic agents, selective serotonin reuptake inhibitors (SSRIs), or monoamine oxidase inhibitors (MAOIs)
• Patients who have severe liver disease
• History of pheochromocytoma, untreated hyperthyroidism, untreated or uncontrolled hypertension, carcinoid syndrome
• Evidence of uncontrolled, clinically significant (according to the judgment of the Investigator) cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, or endocrine disease; malignancy or psychiatric disorder
• Current evidence of deep vein thrombosis or superficial thrombophlebitis
• Experienced a recent clinically significant coagulopathy
• Evidence of clinically significant immunosuppression
• Patient who previously enrolled in this study
• Patient who has previously enrolled in any other clinical trial within 4 weeks of enrollment through TOC. Treatment with an investigational drug within 4 weeks prior to study drug administration
• Patient residing in a chronic care facility
• Any underlying condition or disease state that would interfere with the completion of the study procedures and evaluation of the absorption of study drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

1

Experimental group

Description:

Radezolid 450 mg PO QD

Treatment:

Drug: Radezolid

Drug: Radezolid

2

Experimental group

Description:

Radezolid 450 mg PO BID

Treatment:

Drug: Radezolid

Drug: Radezolid

3

Active Comparator group

Description:

Linezolid 600 mg PO BID

Treatment:

Drug: Linezolid