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

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00249197
First received: November 4, 2005
Last updated: June 8, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Skin Diseases, Bacterial
Drug: levofloxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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

Secondary Outcome 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

Enrollment: 413
Study Start Date: January 1997
Study Completion Date: July 1998
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249197

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00249197     History of Changes
Other Study ID Numbers: CR005473
Study First Received: November 4, 2005
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
skin infection
bacterial infection
levofloxacin
quinolones
skin
infection

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Bacterial
Infection
Bacterial Infections
Amoxicillin
Ticarcillin
Ofloxacin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on July 23, 2014