NCT00249197

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
413

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 1997

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1998

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
Last Updated

June 10, 2011

Status Verified

January 1, 2011

First QC Date

November 4, 2005

Last Update Submit

June 8, 2011

Conditions

Skin Diseases, Bacterial

Keywords

skin infectionbacterial infectionlevofloxacinquinolonesskininfection

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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

Interventions

levofloxacinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Graham DR, Talan DA, Nichols RL, Lucasti C, Corrado M, Morgan N, Fowler CL. Once-daily, high-dose levofloxacin versus ticarcillin-clavulanate alone or followed by amoxicillin-clavulanate for complicated skin and skin-structure infections: a randomized, open-label trial. Clin Infect Dis. 2002 Aug 15;35(4):381-9. doi: 10.1086/341026. Epub 2002 Jul 19.

    PMID: 12145720RESULT

Related Links

MeSH Terms

Conditions

Skin Diseases, BacterialCellulitisBacterial InfectionsInfections

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesSuppurationConnective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 7, 2005

Study Start

January 1, 1997

Study Completion

July 1, 1998

Last Updated

June 10, 2011

Record last verified: 2011-01