Clinical trial NCT01811732: Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Keywords: Bacterial skin infection
skin infection
infection
skin
delafloxacin
vancomycin
aztreonam
MRSA bacteria
bacterial infection
Anti-Infective Agents
Anti-Bacterial Agents
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-15
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).

Detailed description: The efficacy and safety of delafloxacin, compared to that of vancomycin plus aztreonam, will be evaluated in a population of patients with acute bacterial skin and soft tissue infections (ABSSSI), including major cutaneous abscesses, wound infections, cellulitis/erysipelas, and burn-related infections.

Eligibility 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 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

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
* Receipt of systemic antibiotic therapy in the 14 days before enrollment unless 1 of the following was documented:

  1. Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is documented (i.e., not by patient history alone).
  2. 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.
  3. Received only 1 dose of either a single, potentially effective, short-acting antimicrobial drug or drug regimen for ABSSSI.
* 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

Primary outcomes:
measure: Objective Response at 48 to 72 Hours (FDA Primary Endpoint)
timeFrame: 48 to 72 hours after starting treatment
Secondary outcomes:
measure: Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint)
timeFrame: Study Day 14 +/- 1 day
measure: Investigator Assessment at the Late Follow-up Visit
timeFrame: Study Day 21 to 28
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Melinta Investigational Site
state: Alabama
city: Anaheim
country: United States
facility: Melinta Investigational Site
state: California
city: Chula Vista
country: United States
facility: Melinta Investigational Site
state: California
city: La Mesa
country: United States
facility: Melinta Investigational Site
state: California
city: Long Beach
country: United States
facility: Melinta Investigational Site
state: California
city: Los Angeles
country: United States
facility: Melinta Investigational Site
state: California
city: Modesto
country: United States
facility: Melinta Investigational Site
state: California
city: Oceanside
country: United States
facility: Melinta Investigational Site
state: California
city: Pasadena
country: United States
facility: Melinta Investigational Site
state: California
city: Stockton
country: United States
facility: Melinta Investigational Site
state: California
city: Miramar
country: United States
facility: Melinta Investigational Site
state: Florida
city: Minneapolis
country: United States
facility: Melinta Investigational Site
state: Minnesota
city: Butte
country: United States
facility: Melinta Investigational Site
state: Montana
city: Las Vegas
country: United States
facility: Melinta Investigational Site
state: Nevada
city: Somers Point
country: United States
facility: Melinta Investigational Site
state: New Jersey
city: Smyrna
country: United States
facility: Melinta Investigational Site
state: Tennessee
city: Richmond
country: United States
facility: Melinta Investigational Site
state: Texas
city: Slavonski Brod
country: Croatia
facility: Melinta Investigational Site
city: Zagreb
country: Croatia
facility: Melinta Investigational Site
city: Zagreb
country: Croatia
facility: Melinta Investigational Site
city: Haifa
country: Israel
facility: Melinta Investigational Site
city: Haifa
country: Israel
facility: Melinta Investigational Site
city: Kfar Saba
country: Israel
facility: Melinta Investigational Site
city: Nazareth
country: Israel
facility: Melinta Investigational Site
city: Safed
country: Israel
facility: Melinta Investigational Site
city: Tel Aviv
country: Israel
facility: Melinta Investigational Site
city: Daugavpils
country: Latvia
facility: Melinta Investigational Site
city: Liepaja
country: Latvia
facility: Melinta Investigational Site
city: Riga
country: Latvia
facility: Melinta Investigational Site
city: Riga
country: Latvia
facility: Melinta Investigational Site
city: Valmiera
country: Latvia
facility: Melinta Investigational Site
city: Moscow
country: Russian Federation
facility: Melinta Investigational Site
city: Perm
country: Russian Federation
facility: Melinta Investigational Site
city: St. Petersberg
country: Russian Federation
facility: Melinta Investigational Site
city: Vsevolozhsk
country: Russian Federation
facility: Melinta Investigational Site
city: Barcelona
country: Spain
facility: Melinta Investigational Site
city: Barcelona
country: Spain
facility: Melinta Investigational Site
city: Granada
country: Spain
facility: Melinta Investigational Site
city: Malaga
country: Spain
facility: Melinta Investigational Site
city: Valencia
country: Spain
facility: Melinta Investigational Site
city: Chemivtsi
country: Ukraine
facility: Melinta Investigational Site
city: Cherkasy
country: Ukraine
facility: Melinta Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Melinta Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Melinta Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Melinta Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Melinta Investigational Site
city: Klarkiv
country: Ukraine
facility: Melinta Investigational Site
city: Lviv
country: Ukraine
facility: Melinta Investigational Site
city: Odessa
country: Ukraine
facility: Melinta Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: Melinta Investigational Site
Study officials:
affiliation: Melinta Therapeutics, Inc.
name: Sue K. Cammarata, MD
role: STUDY_DIRECTOR
References:
citation: Lodise T, Corey R, Hooper D, Cammarata S. Safety of Delafloxacin: Focus on Adverse Events of Special Interest. Open Forum Infect Dis. 2018 Sep 10;5(10):ofy220. doi: 10.1093/ofid/ofy220. eCollection 2018 Oct.
citation: Pullman J, Gardovskis J, Farley B, Sun E, Quintas M, Lawrence L, Ling R, Cammarata S; PROCEED Study Group. Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a Phase 3, double-blind, randomized study. J Antimicrob Chemother. 2017 Dec 1;72(12):3471-3480. doi: 10.1093/jac/dkx329.
citation: McCurdy S, Lawrence L, Quintas M, Woosley L, Flamm R, Tseng C, Cammarata S. In Vitro Activity of Delafloxacin and Microbiological Response against Fluoroquinolone-Susceptible and Nonsusceptible Staphylococcus aureus Isolates from Two Phase 3 Studies of Acute Bacterial Skin and Skin Structure Infections. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e00772-17. doi: 10.1128/AAC.00772-17. Print 2017 Sep.