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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00949130 |
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Date of registration:
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29/07/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
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Scientific title:
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A Multicenter,Investigator-blinded,Randomized, Comparative Study to Evaluate the Efficacy and Safety of Oral NXL103 Versus Oral Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00949130 |
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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: Single Blind (Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Guatemala
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United States
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Contacts
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Name:
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Michael Kuligowski, 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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Novexel Inc |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosed with acute bacterial skin and skin structure infection (ABSSSI) with at
least 3 signs or symptoms
Exclusion Criteria:
- Uncomplicated acute bacterial skin and skin structure infections
- ABSSSI suspected or proven to be due to Gram negative and/or anaerobic pathogens
- Pregnant or lactating women
- Inadequately controlled diabetes mellitus
- Inadequately controlled arterial hypertension
- Moderate-to-severe renal impairment
- Moderate-to-severe liver disease
- Conditions associated with immunodeficiency
- Known hypersensitivity or any contraindication for the use of any of the 2 study
drugs
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Bacterial Skin and Skin Structure Infections
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Intervention(s)
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Drug: NXL103
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Drug: Linezolid
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Primary Outcome(s)
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Clinical response at the early follow-up visit (Test of cure)
[Time Frame: 7 days post therapy]
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Secondary Outcome(s)
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Microbiological outcome at the early follow-up visit (Test of cure)
[Time Frame: 7 days post-therapy]
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Safety Profiles (safety and tolerability)
[Time Frame: throughout the study]
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Population pharmacokinetic profile of the experimental study drug
[Time Frame: Day 1-5 while on study drug]
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Clinical outcome at the end of treatment
[Time Frame: 10-14 days therapy]
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Clinical outcome at the late follow-up visit
[Time Frame: 21 days post therapy]
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Secondary ID(s)
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NXL103/2002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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