Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
NCT ID: NCT00949130
Last Updated: 2010-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2009-11-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NXL103
BID for 7-14 days orally
NXL103
BID for 7-14 days
Linezolid
BID for 7-14 days orally
Linezolid
BID for 7-14 days
Interventions
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NXL103
BID for 7-14 days
Linezolid
BID for 7-14 days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Novexel Inc
INDUSTRY
Responsible Party
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Novexel Inc
Principal Investigators
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Michael Kuligowski, MD
Role: STUDY_DIRECTOR
Novexel Inc
Locations
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Sharp Chula Vista Research Office
Chula Vista, California, United States
Fountain Valley Regional Hospital and Medical Center
Fountain Valley, California, United States
Sharp Grossmont Research Office
La Mesa, California, United States
Tri-City Oceanside Office
Oceanside, California, United States
Southeast Regional Research Group
Columbus, Georgia, United States
Southeast Regional Research Group
Savannah, Georgia, United States
Idaho Falls Infectious Diseases
Idaho Falls, Idaho, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Infectious Diseaes MPLS-LTD
Minneapolis, Minnesota, United States
Mercury Street Medical Group
Butte, Montana, United States
RPS Infectious Diseases
West Reading, Pennsylvania, United States
Roosevelt Hospital
Guatemala City, , Guatemala
UNICAR
Guatemala City, , Guatemala
Military Health Center
Guatemala City, , Guatemala
Private Hospital
Quetzaltenango, , Guatemala
Countries
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Other Identifiers
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NXL103/2002
Identifier Type: -
Identifier Source: org_study_id
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