Official Title: “A Multicenter, Randomized, Open-Label Study to Compare the Safety and Efficacy of i.v. And/Or Oral Levofloxacin With That of Ticarcillin/Clavulanate Alone or Followed by Amoxicillin/Clavulanate in the Treatment of Complicated Bacterial Skin and Skin Structure Infections”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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 infections. Levofloxacin may be taken by mouth or administered slowly through a vein and has been shown to be safe and effective when administered once daily. This multicenter, open-label study will evaluate the safety and effectiveness of a single daily oral or intravenous dose of levofloxacin compared to multiple daily intravenous doses with another antibiotic, ticarcillin/clavulanate given alone or followed by oral amoxicillin/clavulanate, in the treatment of bacterial skin infections. Patients will receive 750 mg of levofloxacin by mouth or intravenously for 7 - 14 days, or 3.1 grams of ticarcillin/clavulanate intravenously for 7 - 14 days. Patients receiving levofloxacin intravenously may be switched to receive levofloxacin by mouth; patients receiving ticarcillin/clavulanate intravenously may be switched to 875 mg of amoxicillin/clavulanate given by mouth, twice daily, if significant improvement is noted. Patients are assessed after 3 - 4 days of treatment; treatment is discontinued if no significant improvement is noted.

Patients showing signs of improvement continue in the study, with assessments 2 - 5 days (post-therapy visit) and 3 - 4 weeks (post-study visit) after completion of the study drug.

The primary measure of effectiveness is the clinical response rate assessed 2 - 5 days after the last dose of antibiotic treatment, categorizing the response as cured, improved, or failed. Laboratory tests for the presence of bacteria are performed throughout the study.

Safety evaluations (incidence of adverse events, physical examinations, laboratory tests) are performed throughout the study. The study hypothesis is that a single daily dose of levofloxacin is at least as effective as multiple daily doses of ticarcillin/clavulanate alone or followed by amoxicillin/clavulanate in the treatment of skin infections, and that it is well tolerated.

Levofloxacin 750 mg intravenously or by mouth, once daily for 7 - 14 days, or ticarcillin/clavulanate 3.1 grams intravenously every 4 - 6 hours, may be switched to amoxicillin/clavulanate 875 mg by mouth, twice daily, total duration 7 - 14 days.

Intervention(s) in this Clinical Trial

• Drug: levofloxacin

Primary Measures

• Clinical response rates at post-therapy, categorized as cured, improved, or failed.

Secondary Measures

• Rate of elimination of disease-causing bacteria post-study, by patient, and by bacteria type; Clinical relapse and new infection rates based upon signs and symptoms at post-study; Microbiologic relapse rates

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00249197

Study ID Number: CR005473

ClinicalTrials.gov Identifier: NCT00249197

Health Authority: United States: Food and Drug Administration

A study of the safety and effectiveness of levofloxacin compared to ticarcillin/clavulanate alone or followed by amoxicillin/clavulanate in the treatment of skin infections