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