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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00061633 |
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Date of registration:
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30/05/2003 |
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Primary sponsor: |
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Public title:
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Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
FAST |
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Scientific title:
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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) |
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Date of first enrolment:
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June 2003 |
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Target sample size:
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169 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00061633 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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G. Ralph Corey, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients must have a diagnosis of one of the following complicated skin and skin
structure infections with either a suspected or confirmed Gram positive organism as
the major cause of the infection:
- 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 infections
- Patients must be expected to require at least 4 days of intravenous 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
medication 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Abscess
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Burns
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Cellulitis
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Infections, Gram-Positive Bacterial
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Ulcer
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Wound Infections
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Intervention(s)
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Drug: Telavancin
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Drug: Vancomycin or antistaphylococcal penicillin
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Primary Outcome(s)
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Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
[Time Frame: 7-14 days following end of antibiotic treatment]
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Secondary ID(s)
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I6424-202a
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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