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

NCT ID: NCT01984684

Last Updated: 2017-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of skin and nearby tissue infections compared with a combination of other antibiotics, vancomycin and aztreonam.

Conditions

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Skin and Subcutaneous Tissue Bacterial Infections Skin Structures and Soft Tissue Infections

Keywords

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Bacterial skin infection infection skin delafloxacin vancomycin aztreonam methicillin-resistant Staphylococcus aureus (MRSA) bacteria bacterial infection Anti-Infective Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Delafloxacin

Delafloxacin 300 mg IV Q12H for 6 doses, then Delafloxacin 450 mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total

Group Type EXPERIMENTAL

delafloxacin

Intervention Type DRUG

Vancomycin plus Aztreonam

Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total (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

aztreonam

Intervention Type DRUG

Interventions

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delafloxacin

Intervention Type DRUG

vancomycin

Intervention Type DRUG

aztreonam

Intervention Type DRUG

Other Intervention Names

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RX-3341

Eligibility Criteria

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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 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 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.
* 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.
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 303 Study Site

Mobile, Alabama, United States

Site Status

Melinta 303 Study Site

Montgomery, Alabama, United States

Site Status

Melinta 303 Study Site

Anaheim, California, United States

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Melinta 303 Study Site

Chula Vista, California, United States

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Melinta 303 Study Site

La Mesa, California, United States

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Melinta 303 Study Site

Long Beach, California, United States

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Melinta 303 Study Site

Modesto, California, United States

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Melinta 303 Study Site

Oceanside, California, United States

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Melinta 303 Study Site

San Diego, California, United States

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Melinta 303 Study Site

Stockton, California, United States

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Melinta 303 Study Site

Torrance, California, United States

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Melinta 303 Study Site

DeLand, Florida, United States

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Melinta 303 Study Site

Orlando, Florida, United States

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Melinta 303 Study Site

Columbus, Georgia, United States

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Melinta 303 Study Site

Savannah, Georgia, United States

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Melinta 303 Study Site

Eunice, Louisiana, United States

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Melinta 303 Study Site

Springfield, Massachusetts, United States

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Melinta 303 Study Site

Minneapolis, Minnesota, United States

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Melinta 303 Study Site

Butte, Montana, United States

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Melinta 303 Study Site

Lincoln, Nebraska, United States

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Melinta 303 Study Site

Las Vegas, Nevada, United States

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Melinta 303 Study Site

Somers Point, New Jersey, United States

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Melinta 303 Study Site

Teaneck, New Jersey, United States

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Melinta 303 Study Site

Columbus, Ohio, United States

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Melinta 303 Study Site

Toledo, Ohio, United States

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Melinta 303 Study Site

Rapid City, South Dakota, United States

Site Status

Melinta 303 Study Site

Jackson, Tennessee, United States

Site Status

Melinta 303 Study Site

Smyrna, Tennessee, United States

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Melinta 303 Study Site

Channelview, Texas, United States

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Melinta 303 Study Site

Houston, Texas, United States

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Melinta 303 Study Site

San Antonio, Texas, United States

Site Status

Melinta 303 Study Site

La Plata, Buenos Aires, Argentina

Site Status

Melinta 303 Study Site

Rosario, Santa Fe Province, Argentina

Site Status

Melinta 303 Study Site

Córdoba, , Argentina

Site Status

Melinta 303 Study Site

Santa Fe, , Argentina

Site Status

Melinta 303 Study Site

Salvador, Estado de Bahia, Brazil

Site Status

Melinta 303 Study Site

Belo Horizonte, Minas Gerais, Brazil

Site Status

Melinta 303 Study Site

Lavras, Minas Gerais, Brazil

Site Status

Melinta 303 Study Site

Passo Fundo, Rio Grande do Sul, Brazil

Site Status

Melinta 303 Study Site

Campinas, São Paulo, Brazil

Site Status

Melinta 303 Study Site

São José do Rio Preto, São Paulo, Brazil

Site Status

Melinta 303 Study Site

São Paulo, , Brazil

Site Status

Melinta 303 Study Site

Pleven, , Bulgaria

Site Status

Melinta 303 Study Site

Plovdiv, , Bulgaria

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Melinta 303 Study Site

Rousse, , Bulgaria

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Melinta 303 Study Site

Sofia, , Bulgaria

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Melinta 303 Study Site

Varna, , Bulgaria

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Melinta 303 Study Site

Santiago, , Chile

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Melinta 303 Study Site

Temuco, , Chile

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Melinta 303 Study Site

Kohtla-Järve, , Estonia

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Melinta 303 Study Site

Tallinn, , Estonia

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Melinta 303 Study Site

Tartu, , Estonia

Site Status

Melinta 303 Study Site

Võru, , Estonia

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Melinta 303 Study Site

Batumi, , Georgia

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Melinta 303 Study Site

Kutaisi, , Georgia

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Melinta 303 Study Site

Tbilisi, , Georgia

Site Status

Melinta 303 Study Site

Zugdidi, , Georgia

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Melinta 303 Study Site

Kaposvár, , Hungary

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Melinta 303 Study Site

Kecskemét, , Hungary

Site Status

Melinta 303 Study Site

Nyíregyháza, , Hungary

Site Status

Melinta 303 Study Site

Szeged, , Hungary

Site Status

Melinta 303 Study Site

Veszprém, , Hungary

Site Status

Melinta 303 Study Site

Daugavpils, , Latvia

Site Status

Melinta 303 Study Site

Liepāja, , Latvia

Site Status

Melinta 303 Study Site

Rēzekne, , Latvia

Site Status

Melinta 303 Study Site

Riga, , Latvia

Site Status

Melinta 303 Study Site

Guadalajara, Jalisco, Mexico

Site Status

Melinta 303 Study Site

Monterrey, Nuevo León, Mexico

Site Status

Melinta 303 Study Site

Chisinau, , Moldova

Site Status

Melinta 303 Study Site

Trujillo, La Libertad, Peru

Site Status

Melinta 303 Study Site

Cusco, , Peru

Site Status

Melinta 303 Study Site

Lima, , Peru

Site Status

Melinta 303 Study Site

Loreto, , Peru

Site Status

Melinta 303 Study Site

Cluj-Napoca, Cluj, Romania

Site Status

Melinta 303 Study Site

Craiova, Dolj, Romania

Site Status

Melinta 303 Study Site

Timișoara, Timiș County, Romania

Site Status

Melinta 303 Study Site

Bucharest, , Romania

Site Status

Melinta 303 Study Site

Târgu Mureş, , Romania

Site Status

Melinta 303 Study Site

Banská Bystrica, , Slovakia

Site Status

Melinta 303 Study Site

Prešov, , Slovakia

Site Status

Melinta 303 Study Site

Wŏnju, Gang'weondo, South Korea

Site Status

Melinta 303 Study Site

Ansan, Gyeonggido, South Korea

Site Status

Melinta 303 Study Site

Goyang, Gyeonggido, South Korea

Site Status

Melinta 303 Study Site

Daegu, , South Korea

Site Status

Melinta 303 Study Site

Daejeon, , South Korea

Site Status

Melinta 303 Study Site

Gwangju, , South Korea

Site Status

Melinta 303 Study Site

Incheon, , South Korea

Site Status

Melinta 303 Study Site

Seoul, , South Korea

Site Status

Melinta 303 Study Site

Kaohsiung City, , Taiwan

Site Status

Melinta 303 Study Site

New Taipei City, , Taiwan

Site Status

Melinta 303 Study Site

Taichung, , Taiwan

Site Status

Melinta 303 Study Site

Tainan City, , Taiwan

Site Status

Melinta 303 Study Site

Taipei, , Taiwan

Site Status

Melinta 303 Study Site

Zhonghe, , Taiwan

Site Status

Countries

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United States Argentina Brazil Bulgaria Chile Estonia Georgia Hungary Latvia Mexico Moldova Peru Romania Slovakia South Korea Taiwan

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)

O'Riordan W, McManus A, Teras J, Poromanski I, Cruz-Saldariagga M, Quintas M, Lawrence L, Liang S, Cammarata S; PROCEED Study Group. A Comparison of the Efficacy and Safety of Intravenous Followed by Oral Delafloxacin With Vancomycin Plus Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections: A Phase 3, Multinational, Double-Blind, Randomized Study. Clin Infect Dis. 2018 Aug 16;67(5):657-666. doi: 10.1093/cid/ciy165.

Reference Type DERIVED
PMID: 29518178 (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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RX-3341-303

Identifier Type: -

Identifier Source: org_study_id