Skin Diseases, Infectious Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized Study to Compare the Safety and Efficacy of Oral Levofloxacin With That of Ciprofloxacin HCl in the Treatment of Uncomplicated Skin and Skin Structure Infections in Adults
The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with another antibiotic, ciprofloxacin, in the treatment of adults with uncomplicated infections of the skin and the supportive layers beneath the skin.
Status | Completed |
Enrollment | 361 |
Est. completion date | April 1994 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of infection of the skin and/or the supportive layers beneath the skin, as indicated by pain at the site of the infection, redness, swelling, drainage, or other relevant clinical signs - able to provide a sample of tissue from the affected area of the skin - able to receive oral medications. Exclusion Criteria: - Patients with a condition requiring treatment with antibiotics by injection into a vein, a muscle, or beneath the skin - having a severe infection - previous allergic or serious adverse reaction to similar antibiotics, or have severe lactose intolerance - taken antibiotics internally within 48 hours of the start of the study with resulting improvement - requirement of a second antibiotic taken internally or requirement of an antibiotic applied directly to the site of the infection in addition to the study drug |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | PriCara, Unit of Ortho-McNeil, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical response rate at post-therapy (defined as cured, improved or failed); microbiological response at post-therapy (rate of elimination of disease-causing bacteria, by patient, and by type of bacteria); incidence of adverse events | |||
Secondary | Changes in physical examination and laboratory tests after treatment with the study drug |
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