Recruitment

Recruitment Status
Completed
Estimated Enrollment
660

Inclusion Criterias

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
Adult (≥ 18 years of age) men or women with a diagnosis of ABSSSI (cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection) with surrounding redness of a minimum surface area of 75 cm^2 and 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
Adult (≥ 18 years of age) men or women with a diagnosis of ABSSSI (cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection) with surrounding redness of a minimum surface area of 75 cm^2 and at least two signs of systemic infection

Exclusion Criterias

Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is documented (i.e., not by patient history alone).
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.
Received only 1 dose of either a single, potentially effective, short-acting antimicrobial drug or drug regimen for ABSSSI.
...
Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is documented (i.e., not by patient history alone).
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.
Received only 1 dose of either a single, potentially effective, short-acting antimicrobial drug or drug regimen for ABSSSI.
Women who are pregnant or lactating.
A medical history of significant hypersensitivity or allergic reaction to quinolones, beta-lactams, vancomycin, or vancomycin derivatives according to the judgment of the investigator.
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.
Recently (within 14 days) completed a treatment course with an antibacterial drug for an infection other than ABSSSI and the drug does not have activity against bacterial pathogens that cause ABSSSI.

Summary

Conditions
  • Skin and Subcutaneous Tissue Bacterial Infections
  • Skin Structures and Soft Tissue Infections
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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.

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.

Inclusion Criterias

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
Adult (≥ 18 years of age) men or women with a diagnosis of ABSSSI (cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection) with surrounding redness of a minimum surface area of 75 cm^2 and 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
Adult (≥ 18 years of age) men or women with a diagnosis of ABSSSI (cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection) with surrounding redness of a minimum surface area of 75 cm^2 and at least two signs of systemic infection

Exclusion Criterias

Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is documented (i.e., not by patient history alone).
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.
Received only 1 dose of either a single, potentially effective, short-acting antimicrobial drug or drug regimen for ABSSSI.
...
Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is documented (i.e., not by patient history alone).
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.
Received only 1 dose of either a single, potentially effective, short-acting antimicrobial drug or drug regimen for ABSSSI.
Women who are pregnant or lactating.
A medical history of significant hypersensitivity or allergic reaction to quinolones, beta-lactams, vancomycin, or vancomycin derivatives according to the judgment of the investigator.
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.
Recently (within 14 days) completed a treatment course with an antibacterial drug for an infection other than ABSSSI and the drug does not have activity against bacterial pathogens that cause ABSSSI.

Locations

Daegu
Springfield, Massachusetts
Banska Bystrica
Kecskemét
Channelview, Texas, 77530
...
Daegu
Springfield, Massachusetts
Banska Bystrica
Kecskemét
Channelview, Texas, 77530
Somers Point, New Jersey, 08244
Columbus, Georgia, 31904
Eunice, Louisiana, 70535
Voru
Zugdidi
DeLand, Florida
Wŏnju, Gang'weondo
Gwangju
Long Beach, California
Tbilisi
Liepaja
Bucharest
La Plata, Buenos Aires
Cluj-Napoca, Cluj
Temuco
Rapid City, South Dakota
Passo Fundo, Rio Grande Do Sul
Goyang, Gyeonggido
Veszprem
Guadalajara, Jalisco
Kaposvar
Taichung
Trujillo, La Libertad
Savannah, Georgia, 31405
Houston, Texas, 77024
Incheon
Cordoba
La Mesa, California, 91942
Modesto, California
Campinas, Sao Paulo
Las Vegas, Nevada, 89109
Targu mures
Belo Horizonte, Minas Gerais
Taipei
Varna
Szeged
Daugavpils
Tainan City
Lima
Ruse
Rezekne
Timisoara, Timis
Tartu
Ansan, Gyeonggido
Sao Paulo
Tallinn
Loreto
Mobile, Alabama, 36607
Craiova, Dolj
Jackson, Tennessee
Zhonghe
Chisinau
Rosario, Santa Fe
Smyrna, Tennessee
Monterrey, Nuevo Leon
Santiago
Presov
Pleven
Orlando, Florida
New Taipei City
San Diego, California, 92114
Torrance, California, 90509
Daejeon
Lincoln, Nebraska
Toledo, Ohio
Oceanside, California, 92056
Salvador, Bahia
Lavras, Minas Gerais
Cusco
Seoul
Kutaisi
Sofia
Plovdiv
Columbus, Ohio
Chula Vista, California, 91911
Montgomery, Alabama
Stockton, California
Nyiregyhaza
Anaheim, California
Santa Fe
Kaohsiung
Butte, Montana
Kohtla-Järve
Riga
Teaneck, New Jersey
San Antonio, Texas
São José Do Rio Preto, Sao Paulo
Minneapolis, Minnesota, 55422
Batumi

Tracking Information

NCT #
NCT01984684
Collaborators
Not Provided
Investigators
Study Director: Sue K Cammarata, MD Melinta Therapeutics, Inc.