Cellulitis Clinical Trial
Official title:
A Multicenter, Active-Controlled, Randomized Study to Evaluate the Safety and Efficacy of Levofloxacin Versus Ciprofloxacin HCl in the Treatment of Mild to Moderate 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 ciprofloxacin, another antibiotic, in the treatment of adults with mild to moderate infections of the skin and the supportive layers beneath the skin.
Status | Completed |
Enrollment | 431 |
Est. completion date | February 1993 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of mild to moderate infection of the skin and/or the supportive layers beneath the skin, as indicated by pain at the site of the infection, redness, drainage, swelling, or other relevant clinical signs - tissue sample available from the area of the skin affected by the bacteria - able to take medication by mouth 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 reactions to similar antibiotics - taken antibiotics internally within 48 hours of the start of the study with resulting improvement - require a second antibiotic taken internally or need 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: Open Label, 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 (defined as cured, improved or failed) 2 - 7 days after the last dose of the study drug; rate of elimination of disease-causing bacteria (by patient, and by type of bacteria); incidence of adverse events. | |||
Secondary | Change in physical examination and in laboratory tests after treatment with the study drug. |
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