Status:
COMPLETED
A Study of the Safety and Effectiveness of Levofloxacin Compared to Ticarcillin/Clavulanate Alone or Followed by Amoxicillin/Clavulanate in the Treatment of Complicated Skin Infections
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Skin Diseases, Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the safety and effectiveness of levofloxacin (an antibiotic) with ticarcillin/clavulanate alone or followed by amoxicillin/clavulanate in the treatment of compl...
Detailed Description
Levofloxacin is an antibiotic that has been evaluated in clinical trials for use in the treatment of many types of infections including respiratory tract, urinary tract, and uncomplicated skin infecti...
Eligibility Criteria
Inclusion
- Diagnosis of bacterial skin and skin structure infection with a complicating factor, (including a pre-existing skin lesion, or a condition affecting the way the drug gets to the infected area of the body, the body's disease defense (immune) system, or the ability of tissues to heal properly)
- have at least 2 of the following signs and symptoms of skin infection: pain, redness, swelling, hardness, pus formation
- have an infection of one of the following types: wound infections (crush, puncture, cut, gunshot, surgery, bite), infected skin ulcers, or infections in patients with decreased immune system function (HIV infections, diabetes, etc)
- able to provide a sample of tissue from the affected area of the skin
Exclusion
- Patients with multiple infected ulcers at separate locations on body
- requiring immediate surgery at the infection site
- having low blood pressure, decreased urination, decreased kidney function, seizure disorder, unstable mental disorder, low white blood cell count, bone infection, shock, or are HIV positive
- having an infection from a bacteria known to be resistant to any of the study drugs
- having a previous allergic or serious reaction to any of the study drugs
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 1998
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT00249197
Start Date
January 1 1997
End Date
July 1 1998
Last Update
June 10 2011
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