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Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections

Primary Purpose

Skin Structure Infections, Bacterial Skin Diseases, Staphylococcal Skin Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
delafloxacin
delafloxacin
tigecycline
Sponsored by
Melinta Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Structure Infections focused on measuring complicated, skin

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 cSSSI
  • Diagnosis of one of the following 3 types of cSSSI: wound infection that has developed within 30 days of surgery, trauma, or a bite injury; abscess that has developed in the 7 days before enrollment; or cellulitis that has developed in the 7 days before enrollment
  • Sexually active men and women of childbearing potential must agree to use an acceptable form of contraception, as determined by the investigator, during participation in the study and for 30 days after the final dose of study drug
  • The patient must be willing to comply with protocol requirements

Exclusion Criteria:

  • Medical history of hypersensitivity or allergic reaction to quinolones, tetracycline or tetracycline derivatives
  • Chronic or underlying skin condition at the site of infection
  • Infection involving prosthetic materials or foreign bodies (unless prosthetic material will be removed within 24 hours), infection associated with a human bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene or gas gangrene, burns covering ≥10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis
  • An infection that would normally have a high cure rate after surgical incision alone
  • Any infection expected to require other antimicrobial agents in addition to study drug
  • Receipt of >24 hours of systemic antibiotic therapy in the 7 days before enrollment
  • A severely compromised immune system
  • History of Child-Pugh Class B or C liver disease or severe renal impairment (creatinine clearance of <30 mL/minute)
  • Pregnancy or lactation

Sites / Locations

  • Physician Alliance Research Center
  • Quality of Life Medical Center, LLC
  • Tri City Medical Center
  • Crest Clinical Trials
  • Internal Medicine Associates of Lee County
  • Joseph M. Still Research Foundation, Inc.
  • Southeast Regional Research Group
  • Southeast Regional Research Group
  • Southeast Regional Research Group
  • St. James Health Care
  • Riverside Methodist Hospital
  • West Houston Clinical Research Services
  • Westbury Medical Clinic
  • Clinical Research Puerto Rico, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.

Secondary Outcome Measures

Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.

Full Information

First Posted
July 18, 2008
Last Updated
June 30, 2014
Sponsor
Melinta Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00719810
Brief Title
Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections
Official Title
A Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of RX 3341 Compared With Tigecycline for the Treatment of Complicated Skin and Skin Structure Infections
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (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 assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Structure Infections, Bacterial Skin Diseases, Staphylococcal Skin Infections
Keywords
complicated, skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
delafloxacin
Intervention Description
300 mg intravenous every 12 hours
Intervention Type
Drug
Intervention Name(s)
delafloxacin
Intervention Description
450 mg intravenous every 12 hours
Intervention Type
Drug
Intervention Name(s)
tigecycline
Intervention Description
100 mg then 50 mg intravenous tigecycline every 12 hours
Primary Outcome Measure Information:
Title
Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
Description
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.
Time Frame
14-21 days after the last dose of study drug
Secondary Outcome Measure Information:
Title
Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)
Description
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.
Time Frame
14-21 days after the last dose of study drug

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 cSSSI Diagnosis of one of the following 3 types of cSSSI: wound infection that has developed within 30 days of surgery, trauma, or a bite injury; abscess that has developed in the 7 days before enrollment; or cellulitis that has developed in the 7 days before enrollment Sexually active men and women of childbearing potential must agree to use an acceptable form of contraception, as determined by the investigator, during participation in the study and for 30 days after the final dose of study drug The patient must be willing to comply with protocol requirements Exclusion Criteria: Medical history of hypersensitivity or allergic reaction to quinolones, tetracycline or tetracycline derivatives Chronic or underlying skin condition at the site of infection Infection involving prosthetic materials or foreign bodies (unless prosthetic material will be removed within 24 hours), infection associated with a human bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene or gas gangrene, burns covering ≥10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis An infection that would normally have a high cure rate after surgical incision alone Any infection expected to require other antimicrobial agents in addition to study drug Receipt of >24 hours of systemic antibiotic therapy in the 7 days before enrollment A severely compromised immune system History of Child-Pugh Class B or C liver disease or severe renal impairment (creatinine clearance of <30 mL/minute) Pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne Breen, MD
Organizational Affiliation
Melinta Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Physician Alliance Research Center
City
Anaheim
State/Province
California
Country
United States
Facility Name
Quality of Life Medical Center, LLC
City
Hawaiian Gardens
State/Province
California
Country
United States
Facility Name
Tri City Medical Center
City
Oceanside
State/Province
California
Country
United States
Facility Name
Crest Clinical Trials
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Internal Medicine Associates of Lee County
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Joseph M. Still Research Foundation, Inc.
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Southeast Regional Research Group
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Southeast Regional Research Group
City
Ludowici
State/Province
Georgia
Country
United States
Facility Name
Southeast Regional Research Group
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
St. James Health Care
City
Butte
State/Province
Montana
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
West Houston Clinical Research Services
City
Houston
State/Province
Texas
Country
United States
Facility Name
Westbury Medical Clinic
City
Houston
State/Province
Texas
Country
United States
Facility Name
Clinical Research Puerto Rico, Inc
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
25448332
Citation
O'Riordan W, Mehra P, Manos P, Kingsley J, Lawrence L, Cammarata S. A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections. Int J Infect Dis. 2015 Jan;30:67-73. doi: 10.1016/j.ijid.2014.10.009. Epub 2014 Oct 30.
Results Reference
derived

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Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections

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