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Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Information source: Melinta Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin and Subcutaneous Tissue Bacterial Infections; Skin Structures and Soft Tissue Infections

Intervention: delafloxacin (Drug); vancomycin (Drug); aztreonam (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Melinta Therapeutics, Inc.

Official(s) and/or principal investigator(s):
Sue K Cammarata, MD, Study Director, Affiliation: Melinta Therapeutics, Inc.

Overall contact:
Sue K Cammarata, MD, Phone: 203-848-3342, Email: clinicaltrials@melinta.com

Summary

The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.

Clinical Details

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Controlled Study to Evaluate the Efficacy + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Objective response of ≥20% reduction in lesion erythema area compared to baseline at 48 to 72 hours after initiation of treatment as determined by digital measurements of the leading edge.

Secondary outcome:

Investigator-assessed response of signs and symptoms of infection at the Follow up Visit (EMA primary endpoint)

Investigator-assessed response of signs and symptoms of infection in patients with a baseline BMI ≥30 at the Follow up Visit

Investigator-assessed response of signs and symptoms of infection at the Late Follow-up Visit

Reduction of erythema of ≥30% at 48 to 72 hours when digital measurements are used

Reduction in pain at End of Treatment as measured by ePRO system

Microbiological response of eradicated (documented or presumed) at the Follow-up Visit in all patients

Detailed description: The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of skin and nearby tissue infections compared with a combination of other antibiotics, vancomycin and aztreonam.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult (≥ 18 years of age) men or women with a diagnosis of ABSSSI

(cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection) with at least two signs of systemic infection

- In the opinion of the investigator, the subject must require and be a suitable

candidate for IV antibiotic therapy, and the subject must be able and willing to comply with protocol requirements Exclusion Criteria:

- A medical history of significant hypersensitivity or allergic reaction to quinolones,

beta-lactams, vancomycin, or vancomycin derivatives according to the judgment of the investigator.

- Women who are pregnant or lactating.

- Any chronic or underlying skin condition at the site of infection that may complicate

the assessment of response, including infection involving a prosthetic joint, human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, sustained shock, gangrene or gas gangrene; burns covering ≥10% of body surface area; severely compromised immune system, severely impaired arterial blood supply to an extremity with an ABSSSI, deep vein thrombosis or superficial thrombophlebitis, and requiring either an amputation or multiple debridement procedures.

- Any underlying disease that, in the opinion of the investigator, could interfere with

the subject's ability to participate in the study including severe cardiac disease, known history of liver disease, end-stage renal disease, malignancy, psychiatric disorder, ongoing treatment for seizures or untreated history of seizures, or life expectancy of < 3 months.

Locations and Contacts

Sue K Cammarata, MD, Phone: 203-848-3342, Email: clinicaltrials@melinta.com

Melinta 303 Study Site, Cordoba, Argentina; Recruiting

Melinta 303 Study Site, Santa Fe, Argentina; Recruiting

Melinta 303 Study Site, Sao Paulo, Brazil; Not yet recruiting

Melinta 303 Study Site, Pleven, Bulgaria; Recruiting

Melinta 303 Study Site, Plovdiv, Bulgaria; Recruiting

Melinta 303 Study Site, Ruse, Bulgaria; Recruiting

Melinta 303 Study Site, Sofia, Bulgaria; Recruiting

Melinta 303 Study Site, Varna, Bulgaria; Not yet recruiting

Melinta 303 Study Site, Santiago, Chile; Recruiting

Melinta 303 Study Site, Temuco, Chile; Recruiting

Melinta 303 Study Site, Kohtla-Järve, Estonia; Recruiting

Melinta 303 Study Site, Tallinn, Estonia; Recruiting

Melinta 303 Study Site, Tartu, Estonia; Recruiting

Melinta 303 Study Site, Voru, Estonia; Recruiting

Melinta 303 Study Site, Kaposvar, Hungary; Recruiting

Melinta 303 Study Site, Kecskemét, Hungary; Recruiting

Melinta 303 Study Site, Nyiregyhaza, Hungary; Recruiting

Melinta 303 Study Site, Szeged, Hungary; Recruiting

Melinta 303 Study Site, Veszprem, Hungary; Recruiting

Melinta 303 Study Site, Daegu, Korea, Republic of; Recruiting

Melinta 303 Study Site, Daejeon, Korea, Republic of; Recruiting

Melinta 303 Study Site, Gwangju, Korea, Republic of; Recruiting

Melinta 303 Study Site, Incheon, Korea, Republic of; Recruiting

Melinta 303 Study Site, Seoul, Korea, Republic of; Recruiting

Melinta 303 Study Site, Rezekne, Latvia; Recruiting

Melinta 303 Study Site, Riga, Latvia; Not yet recruiting

Melinta 303 Study Site, Cusco, Peru; Recruiting

Melinta 303 Study Site, Lima, Peru; Recruiting

Melinta 303 Study Site, Loreto, Peru; Recruiting

Melinta 303 Study Site, Banska Bystrica, Slovakia; Recruiting

Melinta 303 Study Site, Kaohsiung, Taiwan; Recruiting

Melinta 303 Study Site, Taichung, Taiwan; Recruiting

Melinta 303 Study Site, Tainan City, Taiwan; Recruiting

Melinta 303 Study Site, Taipei, Taiwan; Recruiting

Melinta 303 Study Site, Zhonghe, Taiwan; Recruiting

Melinta 303 Study Site, Mobile, Alabama 36607, United States; Recruiting

Melinta 303 Study Site, La Plata, Buenos Aires, Argentina; Not yet recruiting

Melinta 303 Study Site, Anaheim, California, United States; Recruiting

Melinta 303 Study Site, Chula Vista, California 91911, United States; Active, not recruiting

Melinta 303 Study Site, La Mesa, California 91942, United States; Active, not recruiting

Melinta 303 Study Site, Modesto, California, United States; Recruiting

Melinta 303 Study Site, Oceanside, California 92056, United States; Recruiting

Melinta 303 Study Site, San Diego, California 92114, United States; Recruiting

Melinta 303 Study Site, Torrance, California 90509, United States; Recruiting

Melinta 303 Study Site, Wonju-si, Gang'weondo, Korea, Republic of; Recruiting

Melinta 303 Study Site, Columbus, Georgia 31904, United States; Recruiting

Melinta 303 Study Site, Savannah, Georgia 31405, United States; Completed

Melinta 303 Study Site, Ansan, Gyeonggido, Korea, Republic of; Recruiting

Melinta 303 Study Site, Goyang-si, Gyeonggido, Korea, Republic of; Recruiting

Melinta 303 Study Site, Guadalajara, Jalisco, Mexico; Recruiting

Melinta 303 Study Site, Trujillo, La Libertad, Peru; Recruiting

Melinta 303 Study Site, Eunice, Louisiana 70535, United States; Not yet recruiting

Melinta 303 Study Site, Belo Horizonte, Minas Gerais, Brazil; Not yet recruiting

Melinta 303 Study Site, Lavras, Minas Gerais, Brazil; Not yet recruiting

Melinta 303 Study Site, Minneapolis, Minnesota 55422, United States; Recruiting

Melinta 303 Study Site, Las Vegas, Nevada 89109, United States; Recruiting

Melinta 303 Study Site, Somers Point, New Jersey 08244, United States; Recruiting

Melinta 303 Study Site, Teaneck, New Jersey, United States; Not yet recruiting

Melinta 303 Study Site, Passo Fundo, Rio Grande do Sul, Brazil; Not yet recruiting

Melinta 303 Study Site, Rosario, Santa Fe, Argentina; Recruiting

Melinta 303 Study Site, Campinas, Sao Paulo, Brazil; Not yet recruiting

Melinta 303 Study Site, São José Do Rio Preto, Sao Paulo, Brazil; Not yet recruiting

Melinta 303 Study Site, Channelview, Texas 77530, United States; Active, not recruiting

Melinta 303 Study Site, Houston, Texas 77024, United States; Recruiting

Additional Information

Starting date: May 2014
Last updated: May 1, 2015

Page last updated: August 23, 2015

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