DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Delafloxacin Versus 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

Intervention: Delafloxacin (Drug); Vancomycin (Drug); Aztreonam (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Melinta Therapeutics, Inc.

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

Summary

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

Clinical Details

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of 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), Primary Purpose: Treatment

Primary outcome: area measurements of lesion erythema at primary infection site

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 body mass index ≥30 at the Follow-up Visit

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

Objective response using reduction of erythema of ≥30% at 48 to 72 hours when digital measurements are used

Reduction of erythema of ≥80% at the Follow-up Visit when digital measurements are used

Detailed description: The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with complicated bacterial and soft tissue infections

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 Acute Bacterial Skin and

Skin Structure Infections (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 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

Melinta Investigational Site, Slavonski Brod 35000, Croatia

Melinta Investigational Site, Zagreb 10000, Croatia

Melinta Investigational Site, Zagreb 10001, Croatia

Melinta Investigational Site, Haifa 31096, Israel

Melinta Investigational Site, Haifa 31048, Israel

Melinta Investigational Site, Kfar Saba 44281, Israel

Melinta Investigational Site, Nazareth 16100, Israel

Melinta Investigational Site, Safed 13100, Israel

Melinta Investigational Site, Tel Aviv 64239, Israel

Melinta Investigational Site, Daugavpils LV-5417, Latvia

Melinta Investigational Site, Liepaja LV-3414, Latvia

Melinta Investigational Site, Riga LV-1006, Latvia

Melinta Investigational Site, Riga LV-1002, Latvia

Melinta Investigational Site, Valmiera LV-4201, Latvia

Melinta Investigational Site, Moscow 111539, Russian Federation

Melinta Investigational Site, Perm 614107, Russian Federation

Melinta Investigational Site, St. Petersberg 194354, Russian Federation

Melinta Investigational Site, Vsevolozhsk 188640, Russian Federation

Melinta Investigational Site, Barcelona 08003, Spain

Melinta Investigational Site, Barcelona 08221, Spain

Melinta Investigational Site, Granada 18014, Spain

Melinta Investigational Site, Malaga 29010, Spain

Melinta Investigational Site, Valencia 46010, Spain

Melinta Investigational Site, Chemivtsi 58002, Ukraine

Melinta Investigational Site, Cherkasy 18009, Ukraine

Melinta Investigational Site, Dnipropetrovsk 49005, Ukraine

Melinta Investigational Site, Dnipropetrovsk 49027, Ukraine

Melinta Investigational Site, Ivano-Frankivsk 61037, Ukraine

Melinta Investigational Site, Ivano-Frankivsk 76014, Ukraine

Melinta Investigational Site, Klarkiv 61037, Ukraine

Melinta Investigational Site, Lviv 79059, Ukraine

Melinta Investigational Site, Odessa 65025, Ukraine

Melinta Investigational Site, Zaporizhzhia 69104, Ukraine

Melinta Investigational Site, Montgomery, Alabama 36106, United States

Melinta Investigational Site, Anaheim, California 92804, United States

Melinta Investigational Site, Chula Vista, California 91911, United States

Melinta Investigational Site, La Mesa, California 91942, United States

Melinta Investigational Site, Long Beach, California 90813, United States

Melinta Investigational Site, Los Angeles, California 90015, United States

Melinta Investigational Site, Modesto, California 95350, United States

Melinta Investigational Site, Oceanside, California 92056, United States

Melinta Investigational Site, Pasadena, California 91105, United States

Melinta Investigational Site, Stockton, California 95204, United States

Melinta Investigational Site, Miramar, Florida 33027, United States

Melinta Investigational Site, Minneapolis, Minnesota 55422, United States

Melinta Investigational Site, Butte, Montana 59701, United States

Melinta Investigational Site, Las Vegas, Nevada 89109, United States

Melinta Investigational Site, Somers Point, New Jersey 08244, United States

Melinta Investigational Site, Smyrna, Tennessee 37167, United States

Melinta Investigational Site, Richmond, Texas 77469, United States

Additional Information

Starting date: April 2013
Last updated: July 16, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017