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

Skin and Subcutaneous Tissue Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811732
• Other study ID #: RX-3341-302
• Secondary ID: 2012-001767-71
• Status: Completed
• Phase: Phase 3
• First received: March 8, 2013
• Last updated: August 29, 2017
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2017
• Source: Melinta Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection
• Skin and Subcutaneous Tissue Bacterial Infections

Intervention

Drug:
• Delafloxacin
Delafloxacin
• Vancomycin
Vancomycin
• Aztreonam
Aztreonam
• Placebo
Placebo

Locations

Country	Name	City	State
Croatia	Melinta Investigational Site	Slavonski Brod
Croatia	Melinta Investigational Site	Zagreb
Croatia	Melinta Investigational Site	Zagreb
Israel	Melinta Investigational Site	Haifa
Israel	Melinta Investigational Site	Haifa
Israel	Melinta Investigational Site	Kfar Saba
Israel	Melinta Investigational Site	Nazareth
Israel	Melinta Investigational Site	Safed
Israel	Melinta Investigational Site	Tel Aviv
Latvia	Melinta Investigational Site	Daugavpils
Latvia	Melinta Investigational Site	Liepaja
Latvia	Melinta Investigational Site	Riga
Latvia	Melinta Investigational Site	Riga
Latvia	Melinta Investigational Site	Valmiera
Russian Federation	Melinta Investigational Site	Moscow
Russian Federation	Melinta Investigational Site	Perm
Russian Federation	Melinta Investigational Site	St. Petersberg
Russian Federation	Melinta Investigational Site	Vsevolozhsk
Spain	Melinta Investigational Site	Barcelona
Spain	Melinta Investigational Site	Barcelona
Spain	Melinta Investigational Site	Granada
Spain	Melinta Investigational Site	Malaga
Spain	Melinta Investigational Site	Valencia
Ukraine	Melinta Investigational Site	Chemivtsi
Ukraine	Melinta Investigational Site	Cherkasy
Ukraine	Melinta Investigational Site	Dnipropetrovsk
Ukraine	Melinta Investigational Site	Dnipropetrovsk
Ukraine	Melinta Investigational Site	Ivano-Frankivsk
Ukraine	Melinta Investigational Site	Ivano-Frankivsk
Ukraine	Melinta Investigational Site	Klarkiv
Ukraine	Melinta Investigational Site	Lviv
Ukraine	Melinta Investigational Site	Odessa
Ukraine	Melinta Investigational Site	Zaporizhzhia
United States	Melinta Investigational Site	Anaheim	California
United States	Melinta Investigational Site	Butte	Montana
United States	Melinta Investigational Site	Chula Vista	California
United States	Melinta Investigational Site	La Mesa	California
United States	Melinta Investigational Site	Las Vegas	Nevada
United States	Melinta Investigational Site	Long Beach	California
United States	Melinta Investigational Site	Los Angeles	California
United States	Melinta Investigational Site	Minneapolis	Minnesota
United States	Melinta Investigational Site	Miramar	Florida
United States	Melinta Investigational Site	Modesto	California
United States	Melinta Investigational Site	Montgomery	Alabama
United States	Melinta Investigational Site	Oceanside	California
United States	Melinta Investigational Site	Pasadena	California
United States	Melinta Investigational Site	Richmond	Texas
United States	Melinta Investigational Site	Smyrna	Tennessee
United States	Melinta Investigational Site	Somers Point	New Jersey
United States	Melinta Investigational Site	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
Melinta Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Croatia,  Israel,  Latvia,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response at 48 to 72 Hours (FDA Primary Endpoint)	A patient was considered a responder if s/he had a =20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had <20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.	48 to 72 hours after starting treatment
Secondary	Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint)	A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.; A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing).	Study Day 14 +/- 1 day
Secondary	Investigator Assessment at the Late Follow-up Visit	A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.; A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing).	Study Day 21 to 28