Overview

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

Status:
Completed
Trial end date:
1998-07-01
Target enrollment:
0
Participant gender:
All
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 complicated skin infections.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Treatments:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acid
Clavulanic Acids
Levofloxacin
Ofloxacin
Ticarcillin
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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