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

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
delafloxacin
vancomycin
aztreonam
Sponsored by
Melinta Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin and Subcutaneous Tissue Bacterial Infections focused on measuring Bacterial skin infection, infection, skin, delafloxacin, vancomycin, aztreonam, methicillin-resistant Staphylococcus aureus (MRSA) bacteria, bacterial infection, Anti-Infective Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site
  • Melinta 303 Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Delafloxacin

Vancomycin plus Aztreonam

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Objective Response of ≥20% Reduction in Lesion Erythema Area Compared to Baseline at 48 to 72 Hours After Initiation of Treatment as Determined by Digital Measurements of the Leading Edge.
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.

Secondary Outcome Measures

Investigator-assessed Response of Signs and Symptoms of Infection at the Follow up Visit (European Medicines Agency [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).
Investigator-assessed Response of Signs and Symptoms of Infection 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).

Full Information

First Posted
November 8, 2013
Last Updated
November 13, 2017
Sponsor
Melinta Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01984684
Brief Title
Delafloxacin vs 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 + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melinta Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin and Subcutaneous Tissue Bacterial Infections, Skin Structures and Soft Tissue Infections
Keywords
Bacterial skin infection, infection, skin, delafloxacin, vancomycin, aztreonam, methicillin-resistant Staphylococcus aureus (MRSA) bacteria, bacterial infection, Anti-Infective Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
850 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Delafloxacin
Arm Type
Experimental
Arm Description
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
Arm Title
Vancomycin plus Aztreonam
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
delafloxacin
Other Intervention Name(s)
RX-3341
Intervention Type
Drug
Intervention Name(s)
vancomycin
Intervention Type
Drug
Intervention Name(s)
aztreonam
Primary Outcome Measure Information:
Title
Objective Response of ≥20% Reduction in Lesion Erythema Area Compared to Baseline at 48 to 72 Hours After Initiation of Treatment as Determined by Digital Measurements of the Leading Edge.
Description
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.
Time Frame
48 to 72 hrs after starting treatment
Secondary Outcome Measure Information:
Title
Investigator-assessed Response of Signs and Symptoms of Infection at the Follow up Visit (European Medicines Agency [EMA] Primary Endpoint)
Description
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).
Time Frame
Study Day 14 ± 1
Title
Investigator-assessed Response of Signs and Symptoms of Infection at the Late Follow-up Visit
Description
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).
Time Frame
Study Day 21 to 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue K Cammarata, MD
Organizational Affiliation
Melinta Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Melinta 303 Study Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Facility Name
Melinta 303 Study Site
City
Montgomery
State/Province
Alabama
Country
United States
Facility Name
Melinta 303 Study Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Melinta 303 Study Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Melinta 303 Study Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Melinta 303 Study Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
Melinta 303 Study Site
City
Modesto
State/Province
California
Country
United States
Facility Name
Melinta 303 Study Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Melinta 303 Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Melinta 303 Study Site
City
Stockton
State/Province
California
Country
United States
Facility Name
Melinta 303 Study Site
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Melinta 303 Study Site
City
DeLand
State/Province
Florida
Country
United States
Facility Name
Melinta 303 Study Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Melinta 303 Study Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Melinta 303 Study Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Melinta 303 Study Site
City
Eunice
State/Province
Louisiana
ZIP/Postal Code
70535
Country
United States
Facility Name
Melinta 303 Study Site
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Melinta 303 Study Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Melinta 303 Study Site
City
Butte
State/Province
Montana
Country
United States
Facility Name
Melinta 303 Study Site
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
Melinta 303 Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Melinta 303 Study Site
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Melinta 303 Study Site
City
Teaneck
State/Province
New Jersey
Country
United States
Facility Name
Melinta 303 Study Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Melinta 303 Study Site
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Melinta 303 Study Site
City
Rapid City
State/Province
South Dakota
Country
United States
Facility Name
Melinta 303 Study Site
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
Melinta 303 Study Site
City
Smyrna
State/Province
Tennessee
Country
United States
Facility Name
Melinta 303 Study Site
City
Channelview
State/Province
Texas
ZIP/Postal Code
77530
Country
United States
Facility Name
Melinta 303 Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Melinta 303 Study Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Melinta 303 Study Site
City
La Plata
State/Province
Buenos Aires
Country
Argentina
Facility Name
Melinta 303 Study Site
City
Rosario
State/Province
Santa Fe
Country
Argentina
Facility Name
Melinta 303 Study Site
City
Cordoba
Country
Argentina
Facility Name
Melinta 303 Study Site
City
Santa Fe
Country
Argentina
Facility Name
Melinta 303 Study Site
City
Salvador
State/Province
Bahia
Country
Brazil
Facility Name
Melinta 303 Study Site
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Melinta 303 Study Site
City
Lavras
State/Province
Minas Gerais
Country
Brazil
Facility Name
Melinta 303 Study Site
City
Passo Fundo
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Melinta 303 Study Site
City
Campinas
State/Province
Sao Paulo
Country
Brazil
Facility Name
Melinta 303 Study Site
City
São José Do Rio Preto
State/Province
Sao Paulo
Country
Brazil
Facility Name
Melinta 303 Study Site
City
Sao Paulo
Country
Brazil
Facility Name
Melinta 303 Study Site
City
Pleven
Country
Bulgaria
Facility Name
Melinta 303 Study Site
City
Plovdiv
Country
Bulgaria
Facility Name
Melinta 303 Study Site
City
Ruse
Country
Bulgaria
Facility Name
Melinta 303 Study Site
City
Sofia
Country
Bulgaria
Facility Name
Melinta 303 Study Site
City
Varna
Country
Bulgaria
Facility Name
Melinta 303 Study Site
City
Santiago
Country
Chile
Facility Name
Melinta 303 Study Site
City
Temuco
Country
Chile
Facility Name
Melinta 303 Study Site
City
Kohtla-Järve
Country
Estonia
Facility Name
Melinta 303 Study Site
City
Tallinn
Country
Estonia
Facility Name
Melinta 303 Study Site
City
Tartu
Country
Estonia
Facility Name
Melinta 303 Study Site
City
Voru
Country
Estonia
Facility Name
Melinta 303 Study Site
City
Batumi
Country
Georgia
Facility Name
Melinta 303 Study Site
City
Kutaisi
Country
Georgia
Facility Name
Melinta 303 Study Site
City
Tbilisi
Country
Georgia
Facility Name
Melinta 303 Study Site
City
Zugdidi
Country
Georgia
Facility Name
Melinta 303 Study Site
City
Kaposvar
Country
Hungary
Facility Name
Melinta 303 Study Site
City
Kecskemét
Country
Hungary
Facility Name
Melinta 303 Study Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Melinta 303 Study Site
City
Szeged
Country
Hungary
Facility Name
Melinta 303 Study Site
City
Veszprem
Country
Hungary
Facility Name
Melinta 303 Study Site
City
Wŏnju
State/Province
Gang'weondo
Country
Korea, Republic of
Facility Name
Melinta 303 Study Site
City
Ansan
State/Province
Gyeonggido
Country
Korea, Republic of
Facility Name
Melinta 303 Study Site
City
Goyang
State/Province
Gyeonggido
Country
Korea, Republic of
Facility Name
Melinta 303 Study Site
City
Daegu
Country
Korea, Republic of
Facility Name
Melinta 303 Study Site
City
Daejeon
Country
Korea, Republic of
Facility Name
Melinta 303 Study Site
City
Gwangju
Country
Korea, Republic of
Facility Name
Melinta 303 Study Site
City
Incheon
Country
Korea, Republic of
Facility Name
Melinta 303 Study Site
City
Seoul
Country
Korea, Republic of
Facility Name
Melinta 303 Study Site
City
Daugavpils
Country
Latvia
Facility Name
Melinta 303 Study Site
City
Liepaja
Country
Latvia
Facility Name
Melinta 303 Study Site
City
Rezekne
Country
Latvia
Facility Name
Melinta 303 Study Site
City
Riga
Country
Latvia
Facility Name
Melinta 303 Study Site
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Melinta 303 Study Site
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Melinta 303 Study Site
City
Chisinau
Country
Moldova, Republic of
Facility Name
Melinta 303 Study Site
City
Trujillo
State/Province
La Libertad
Country
Peru
Facility Name
Melinta 303 Study Site
City
Cusco
Country
Peru
Facility Name
Melinta 303 Study Site
City
Lima
Country
Peru
Facility Name
Melinta 303 Study Site
City
Loreto
Country
Peru
Facility Name
Melinta 303 Study Site
City
Cluj-Napoca
State/Province
Cluj
Country
Romania
Facility Name
Melinta 303 Study Site
City
Craiova
State/Province
Dolj
Country
Romania
Facility Name
Melinta 303 Study Site
City
Timisoara
State/Province
Timis
Country
Romania
Facility Name
Melinta 303 Study Site
City
Bucharest
Country
Romania
Facility Name
Melinta 303 Study Site
City
Targu mures
Country
Romania
Facility Name
Melinta 303 Study Site
City
Banska Bystrica
Country
Slovakia
Facility Name
Melinta 303 Study Site
City
Presov
Country
Slovakia
Facility Name
Melinta 303 Study Site
City
Kaohsiung
Country
Taiwan
Facility Name
Melinta 303 Study Site
City
New Taipei City
Country
Taiwan
Facility Name
Melinta 303 Study Site
City
Taichung
Country
Taiwan
Facility Name
Melinta 303 Study Site
City
Tainan City
Country
Taiwan
Facility Name
Melinta 303 Study Site
City
Taipei
Country
Taiwan
Facility Name
Melinta 303 Study Site
City
Zhonghe
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30349845
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.
Results Reference
derived
PubMed Identifier
29518178
Citation
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.
Results Reference
derived
PubMed Identifier
28630189
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.
Results Reference
derived

Learn more about this trial

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

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