NCT00719810

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 3, 2010

Completed
Last Updated

July 14, 2014

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

July 18, 2008

Results QC Date

January 7, 2010

Last Update Submit

June 30, 2014

Conditions

Skin Structure InfectionsBacterial Skin DiseasesStaphylococcal Skin Infections

Keywords

complicatedskin

Outcome Measures

Primary Outcomes (1)

  • 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.

    14-21 days after the last dose of study drug

Secondary Outcomes (1)

  • Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)

    14-21 days after the last dose of study drug

Study Arms (3)

1

EXPERIMENTAL
Drug: delafloxacin

2

EXPERIMENTAL
Drug: delafloxacin

3

ACTIVE COMPARATOR
Drug: tigecycline

Interventions

delafloxacinDRUG

300 mg intravenous every 12 hours

1
tigecyclineDRUG

100 mg then 50 mg intravenous tigecycline every 12 hours

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Physician Alliance Research Center

Anaheim, California, United States

Location

Quality of Life Medical Center, LLC

Hawaiian Gardens, California, United States

Location

Tri City Medical Center

Oceanside, California, United States

Location

Crest Clinical Trials

Santa Ana, California, United States

Location

Internal Medicine Associates of Lee County

Fort Myers, Florida, United States

Location

Joseph M. Still Research Foundation, Inc.

Augusta, Georgia, United States

Location

Southeast Regional Research Group

Columbus, Georgia, United States

Location

Southeast Regional Research Group

Ludowici, Georgia, United States

Location

Southeast Regional Research Group

Savannah, Georgia, United States

Location

St. James Health Care

Butte, Montana, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, United States

Location

West Houston Clinical Research Services

Houston, Texas, United States

Location

Westbury Medical Clinic

Houston, Texas, United States

Location

Clinical Research Puerto Rico, Inc

San Juan, Puerto Rico

Location

Related Publications (1)

  • 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.

    PMID: 25448332DERIVED

MeSH Terms

Conditions

Skin Diseases, BacterialStaphylococcal Skin Infections

Interventions

delafloxacinTigecycline

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesStaphylococcal InfectionsGram-Positive Bacterial Infections

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Eugene Sun, M.D.
Organization
Melinta Therapeutics
esun@melinta.com
203.624.5606

Study Officials

  • Jeanne Breen, MD

    Melinta Therapeutics, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2008

First Posted

July 22, 2008

Study Start

June 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

July 14, 2014

Results First Posted

February 3, 2010

Record last verified: 2014-06

Locations

US(13)PR(1)