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

NCT01811732 | Completed Phase 3 Results DMC

• 2 other identifiers: RX-3341-3022012-001767-71
• Study Type: interventional
• Target: 660
• Locations: 7 countries
• Sites: 50

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint)

  Study Day 14 +/- 1 day

• Investigator Assessment at the Late Follow-up Visit

  Study Day 21 to 28

Study Arms (2)

Delafloxacin plus placebo

EXPERIMENTAL

Delafloxacin 300 mg IV every 12 hours for a minimum of 10 and up to a maximum of 28 doses

Drug: Delafloxacin; Drug: Placebo

Vancomycin plus Aztreonam + placebo

ACTIVE COMPARATOR

Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses (Aztreonam was discontinued as soon as possible if a gram-negative organism was not identified in baseline cultures)

Drug: Vancomycin; Drug: Aztreonam; Drug: Placebo

Interventions

Delafloxacin DRUG

Delafloxacin

Also known as: RX-3341

Delafloxacin plus placebo

Vancomycin DRUG

Vancomycin

Vancomycin plus Aztreonam + placebo

Aztreonam DRUG

Aztreonam

Vancomycin plus Aztreonam + placebo

Placebo DRUG

Placebo

Also known as: 5% Dextrose, D5W

Delafloxacin plus placebo; Vancomycin plus Aztreonam + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is documented (i.e., not by patient history alone).
• 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.
• 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

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (50)

Melinta Investigational Site

Montgomery, Alabama, 36106, United States

Location

Melinta Investigational Site

Anaheim, California, 92804, United States

Location

Melinta Investigational Site

Chula Vista, California, 91911, United States

Location

Melinta Investigational Site

La Mesa, California, 91942, United States

Location

Melinta Investigational Site

Long Beach, California, 90813, United States

Location

Melinta Investigational Site

Los Angeles, California, 90015, United States

Location

Melinta Investigational Site

Modesto, California, 95350, United States

Location

Melinta Investigational Site

Oceanside, California, 92056, United States

Location

Melinta Investigational Site

Pasadena, California, 91105, United States

Location

Melinta Investigational Site

Stockton, California, 95204, United States

Location

Melinta Investigational Site

Miramar, Florida, 33027, United States

Location

Melinta Investigational Site

Minneapolis, Minnesota, 55422, United States

Location

Melinta Investigational Site

Butte, Montana, 59701, United States

Location

Melinta Investigational Site

Las Vegas, Nevada, 89109, United States

Location

Melinta Investigational Site

Somers Point, New Jersey, 08244, United States

Location

Melinta Investigational Site

Smyrna, Tennessee, 37167, United States

Location

Melinta Investigational Site

Richmond, Texas, 77469, United States

Location

Melinta Investigational Site

Slavonski Brod, 35000, Croatia

Location

Melinta Investigational Site

Zagreb, 10000, Croatia

Location

Melinta Investigational Site

Zagreb, 10001, Croatia

Location

Melinta Investigational Site

Haifa, 31048, Israel

Location

Melinta Investigational Site

Haifa, 31096, Israel

Location

Melinta Investigational Site

Kfar Saba, 44281, Israel

Location

Melinta Investigational Site

Nazareth, 16100, Israel

Location

Melinta Investigational Site

Safed, 13100, Israel

Location

Melinta Investigational Site

Tel Aviv, 64239, Israel

Location

Melinta Investigational Site

Daugavpils, LV-5417, Latvia

Location

Melinta Investigational Site

Liepāja, LV-3414, Latvia

Location

Melinta Investigational Site

Riga, LV-1002, Latvia

Location

Melinta Investigational Site

Riga, LV-1006, Latvia

Location

Melinta Investigational Site

Valmiera, LV-4201, Latvia

Location

Melinta Investigational Site

Moscow, 111539, Russia

Location

Melinta Investigational Site

Perm, 614107, Russia

Location

Melinta Investigational Site

Saint Petersberg, 194354, Russia

Location

Melinta Investigational Site

Vsevolozhsk, 188640, Russia

Location

Melinta Investigational Site

Barcelona, 08003, Spain

Location

Melinta Investigational Site

Barcelona, 08221, Spain

Location

Melinta Investigational Site

Granada, 18014, Spain

Location

Melinta Investigational Site

Málaga, 29010, Spain

Location

Melinta Investigational Site

Valencia, 46010, Spain

Location

Melinta Investigational Site

Chemivtsi, 58002, Ukraine

Location

Melinta Investigational Site

Cherkasy, 18009, Ukraine

Location

Melinta Investigational Site

Dnipropetrovsk, 49005, Ukraine

Location

Melinta Investigational Site

Dnipropetrovsk, 49027, Ukraine

Location

Melinta Investigational Site

Ivano-Frankivsk, 61037, Ukraine

Location

Melinta Investigational Site

Ivano-Frankivsk, 76014, Ukraine

Location

Melinta Investigational Site

Klarkiv, 61037, Ukraine

Location

Melinta Investigational Site

Lviv, 79059, Ukraine

Location

Melinta Investigational Site

Odesa, 65025, Ukraine

Location

Melinta Investigational Site

Zaporizhzhia, 69104, Ukraine

Location

Related Publications (3)

• 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.

  PMID: 30349845 DERIVED

• 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.

  PMID: 29029278 DERIVED

• 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.

  PMID: 28630189 DERIVED

MeSH Terms

Conditions

Skin Diseases, Bacterial; Cellulitis; Infections; Bacterial Infections

Interventions

delafloxacin; Vancomycin; Aztreonam; Glucose

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Suppuration; Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Monobactams; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hexoses; Monosaccharides; Sugars

Results Point of Contact

• Title: Sue Cammarata (Chief Medical Officer)
• Organization: Melinta Therapeutics, Inc.

clinicaltrials@melinta.com

1-844-MELINTA (1-844-635-4682)

Study Officials

• Sue K. Cammarata, MD

  Melinta Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 15, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 27, 2017
• Results First Posted: August 24, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (3); ES (5); RU (4); US (17); IL (6); LA (5); UA (10)