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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01984684
Other study ID # RX-3341-303
Secondary ID
Status Completed
Phase Phase 3
First received November 8, 2013
Last updated November 13, 2017
Start date May 2014
Est. completion date January 2016

Study information

Verified date November 2017
Source Melinta Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 850
Est. completion date January 2016
Est. primary completion date December 2015
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 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
delafloxacin

vancomycin

aztreonam


Locations

Country Name City State
Argentina Melinta 303 Study Site Cordoba
Argentina Melinta 303 Study Site La Plata Buenos Aires
Argentina Melinta 303 Study Site Rosario Santa Fe
Argentina Melinta 303 Study Site Santa Fe
Brazil Melinta 303 Study Site Belo Horizonte Minas Gerais
Brazil Melinta 303 Study Site Campinas Sao Paulo
Brazil Melinta 303 Study Site Lavras Minas Gerais
Brazil Melinta 303 Study Site Passo Fundo Rio Grande Do Sul
Brazil Melinta 303 Study Site Salvador Bahia
Brazil Melinta 303 Study Site São José Do Rio Preto Sao Paulo
Brazil Melinta 303 Study Site Sao Paulo
Bulgaria Melinta 303 Study Site Pleven
Bulgaria Melinta 303 Study Site Plovdiv
Bulgaria Melinta 303 Study Site Ruse
Bulgaria Melinta 303 Study Site Sofia
Bulgaria Melinta 303 Study Site Varna
Chile Melinta 303 Study Site Santiago
Chile Melinta 303 Study Site Temuco
Estonia Melinta 303 Study Site Kohtla-Järve
Estonia Melinta 303 Study Site Tallinn
Estonia Melinta 303 Study Site Tartu
Estonia Melinta 303 Study Site Voru
Georgia Melinta 303 Study Site Batumi
Georgia Melinta 303 Study Site Kutaisi
Georgia Melinta 303 Study Site Tbilisi
Georgia Melinta 303 Study Site Zugdidi
Hungary Melinta 303 Study Site Kaposvar
Hungary Melinta 303 Study Site Kecskemét
Hungary Melinta 303 Study Site Nyiregyhaza
Hungary Melinta 303 Study Site Szeged
Hungary Melinta 303 Study Site Veszprem
Korea, Republic of Melinta 303 Study Site Ansan Gyeonggido
Korea, Republic of Melinta 303 Study Site Daegu
Korea, Republic of Melinta 303 Study Site Daejeon
Korea, Republic of Melinta 303 Study Site Goyang Gyeonggido
Korea, Republic of Melinta 303 Study Site Gwangju
Korea, Republic of Melinta 303 Study Site Incheon
Korea, Republic of Melinta 303 Study Site Seoul
Korea, Republic of Melinta 303 Study Site Wonju Gang'weondo
Latvia Melinta 303 Study Site Daugavpils
Latvia Melinta 303 Study Site Liepaja
Latvia Melinta 303 Study Site Rezekne
Latvia Melinta 303 Study Site Riga
Mexico Melinta 303 Study Site Guadalajara Jalisco
Mexico Melinta 303 Study Site Monterrey Nuevo Leon
Moldova, Republic of Melinta 303 Study Site Chisinau
Peru Melinta 303 Study Site Cusco
Peru Melinta 303 Study Site Lima
Peru Melinta 303 Study Site Loreto
Peru Melinta 303 Study Site Trujillo La Libertad
Romania Melinta 303 Study Site Bucharest
Romania Melinta 303 Study Site Cluj-Napoca Cluj
Romania Melinta 303 Study Site Craiova Dolj
Romania Melinta 303 Study Site Targu mures
Romania Melinta 303 Study Site Timisoara Timis
Slovakia Melinta 303 Study Site Banska Bystrica
Slovakia Melinta 303 Study Site Presov
Taiwan Melinta 303 Study Site Kaohsiung
Taiwan Melinta 303 Study Site New Taipei City
Taiwan Melinta 303 Study Site Taichung
Taiwan Melinta 303 Study Site Tainan City
Taiwan Melinta 303 Study Site Taipei
Taiwan Melinta 303 Study Site Zhonghe
United States Melinta 303 Study Site Anaheim California
United States Melinta 303 Study Site Butte Montana
United States Melinta 303 Study Site Channelview Texas
United States Melinta 303 Study Site Chula Vista California
United States Melinta 303 Study Site Columbus Georgia
United States Melinta 303 Study Site Columbus Ohio
United States Melinta 303 Study Site DeLand Florida
United States Melinta 303 Study Site Eunice Louisiana
United States Melinta 303 Study Site Houston Texas
United States Melinta 303 Study Site Jackson Tennessee
United States Melinta 303 Study Site La Mesa California
United States Melinta 303 Study Site Las Vegas Nevada
United States Melinta 303 Study Site Lincoln Nebraska
United States Melinta 303 Study Site Long Beach California
United States Melinta 303 Study Site Minneapolis Minnesota
United States Melinta 303 Study Site Mobile Alabama
United States Melinta 303 Study Site Modesto California
United States Melinta 303 Study Site Montgomery Alabama
United States Melinta 303 Study Site Oceanside California
United States Melinta 303 Study Site Orlando Florida
United States Melinta 303 Study Site Rapid City South Dakota
United States Melinta 303 Study Site San Antonio Texas
United States Melinta 303 Study Site San Diego California
United States Melinta 303 Study Site Savannah Georgia
United States Melinta 303 Study Site Smyrna Tennessee
United States Melinta 303 Study Site Somers Point New Jersey
United States Melinta 303 Study Site Springfield Massachusetts
United States Melinta 303 Study Site Stockton California
United States Melinta 303 Study Site Teaneck New Jersey
United States Melinta 303 Study Site Toledo Ohio
United States Melinta 303 Study Site Torrance California

Sponsors (1)

Lead Sponsor Collaborator
Melinta Therapeutics, Inc.

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 48 to 72 hrs after starting treatment
Secondary 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).
Study Day 14 ± 1
Secondary 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).
Study Day 21 to 28
See also
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Completed NCT01283581 - A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections Phase 2
Completed NCT01519492 - A Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections Due to Staphylococci Phase 2
Completed NCT02060513 - Study of Accuracy of New Diagnostic Technology to Determine Guide Rapid Antibiotic Treatment for Serious Infections N/A
Completed NCT01170221 - TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections. Phase 3
Completed NCT01811732 - Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections Phase 3
Completed NCT03964493 - TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection Phase 2