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

NCT ID: NCT01811732

Last Updated: 2017-09-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Skin and Subcutaneous Tissue Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Delafloxacin plus placebo

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

Group Type EXPERIMENTAL

Delafloxacin

Intervention Type DRUG

Delafloxacin

Placebo

Intervention Type DRUG

Placebo

Vancomycin plus Aztreonam + placebo

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)

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Vancomycin

Aztreonam

Intervention Type DRUG

Aztreonam

Placebo

Intervention Type DRUG

Placebo

Interventions

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Delafloxacin

Delafloxacin

Intervention Type DRUG

Vancomycin

Vancomycin

Intervention Type DRUG

Aztreonam

Aztreonam

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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RX-3341 5% Dextrose D5W

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Melinta Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sue K. Cammarata, MD

Role: STUDY_DIRECTOR

Melinta Therapeutics, Inc.

Locations

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Melinta Investigational Site

Montgomery, Alabama, United States

Site Status

Melinta Investigational Site

Anaheim, California, United States

Site Status

Melinta Investigational Site

Chula Vista, California, United States

Site Status

Melinta Investigational Site

La Mesa, California, United States

Site Status

Melinta Investigational Site

Long Beach, California, United States

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Melinta Investigational Site

Los Angeles, California, United States

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Melinta Investigational Site

Modesto, California, United States

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Melinta Investigational Site

Oceanside, California, United States

Site Status

Melinta Investigational Site

Pasadena, California, United States

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Melinta Investigational Site

Stockton, California, United States

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Melinta Investigational Site

Miramar, Florida, United States

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Melinta Investigational Site

Minneapolis, Minnesota, United States

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Melinta Investigational Site

Butte, Montana, United States

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Melinta Investigational Site

Las Vegas, Nevada, United States

Site Status

Melinta Investigational Site

Somers Point, New Jersey, United States

Site Status

Melinta Investigational Site

Smyrna, Tennessee, United States

Site Status

Melinta Investigational Site

Richmond, Texas, United States

Site Status

Melinta Investigational Site

Slavonski Brod, , Croatia

Site Status

Melinta Investigational Site

Zagreb, , Croatia

Site Status

Melinta Investigational Site

Zagreb, , Croatia

Site Status

Melinta Investigational Site

Haifa, , Israel

Site Status

Melinta Investigational Site

Haifa, , Israel

Site Status

Melinta Investigational Site

Kfar Saba, , Israel

Site Status

Melinta Investigational Site

Nazareth, , Israel

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Melinta Investigational Site

Safed, , Israel

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Melinta Investigational Site

Tel Aviv, , Israel

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Melinta Investigational Site

Daugavpils, , Latvia

Site Status

Melinta Investigational Site

Liepāja, , Latvia

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Melinta Investigational Site

Riga, , Latvia

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Melinta Investigational Site

Riga, , Latvia

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Melinta Investigational Site

Valmiera, , Latvia

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Melinta Investigational Site

Moscow, , Russia

Site Status

Melinta Investigational Site

Perm, , Russia

Site Status

Melinta Investigational Site

Saint Petersberg, , Russia

Site Status

Melinta Investigational Site

Vsevolozhsk, , Russia

Site Status

Melinta Investigational Site

Barcelona, , Spain

Site Status

Melinta Investigational Site

Barcelona, , Spain

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Melinta Investigational Site

Granada, , Spain

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Melinta Investigational Site

Málaga, , Spain

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Melinta Investigational Site

Valencia, , Spain

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Melinta Investigational Site

Chemivtsi, , Ukraine

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Melinta Investigational Site

Cherkasy, , Ukraine

Site Status

Melinta Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

Melinta Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

Melinta Investigational Site

Ivano-Frankivsk, , Ukraine

Site Status

Melinta Investigational Site

Ivano-Frankivsk, , Ukraine

Site Status

Melinta Investigational Site

Klarkiv, , Ukraine

Site Status

Melinta Investigational Site

Lviv, , Ukraine

Site Status

Melinta Investigational Site

Odesa, , Ukraine

Site Status

Melinta Investigational Site

Zaporizhzhia, , Ukraine

Site Status

Countries

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United States Croatia Israel Latvia Russia Spain Ukraine

References

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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.

Reference Type DERIVED
PMID: 30349845 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29029278 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28630189 (View on PubMed)

Other Identifiers

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2012-001767-71

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RX-3341-302

Identifier Type: -

Identifier Source: org_study_id