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Trial record 9 of 19 for:    Infections | Oxacillin

Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (FAST2)

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ClinicalTrials.gov Identifier: NCT00077675
Recruitment Status : Completed
First Posted : February 13, 2004
Results First Posted : January 11, 2010
Last Update Posted : January 16, 2019
Sponsor:
Information provided by:
Cumberland Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 10, 2004
First Posted Date  ICMJE February 13, 2004
Results First Submitted Date  ICMJE December 2, 2009
Results First Posted Date  ICMJE January 11, 2010
Last Update Posted Date January 16, 2019
Study Start Date  ICMJE February 2004
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2010)
Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population [ Time Frame: 7 to 14 days following completion of antibiotic treatment ]
  • Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.
  • Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit
  • Indeterminate: Inability to determine outcome.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00077675 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram-Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Brief Summary Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infections, Gram-positive Bacterial
Intervention  ICMJE
  • Drug: Telavancin
    Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days
    Other Names:
    • TD-6424
    • VIBATIV
  • Drug: vancomycin or antistaphylococcal penicillin
    Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.
Study Arms  ICMJE
  • Experimental: Telavancin
    Intervention: Drug: Telavancin
  • Active Comparator: Standard of care for cSSSI
    cSSSI - comlicated skin and skin structure infections
    Intervention: Drug: vancomycin or antistaphylococcal penicillin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2009)
201
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
200
Actual Study Completion Date  ICMJE September 2004
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism

    • major abscess requiring surgical incision and drainage
    • infected burn (see exclusion criteria for important qualifications)
    • deep/extensive cellulitis
    • infected ulcer (see exclusion criteria for important qualifications)
    • wound infection
  • Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment

Exclusion Criteria:

  • Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days)
  • Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00077675
Other Study ID Numbers  ICMJE I6424-202b
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
Study Sponsor  ICMJE Cumberland Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: G. Ralph Corey, MD Duke University
PRS Account Cumberland Pharmaceuticals
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP