NCT00737269

Brief Summary

The purpose of this registry is to better understand (1) complicated skin and soft-tissue infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized patients receiving intravenous antibiotic therapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,081

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

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

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

March 4, 2013

Status Verified

March 1, 2013

Enrollment Period

1.6 years

First QC Date

August 14, 2008

Last Update Submit

March 1, 2013

Conditions

Staphylococcal Skin InfectionsDiabetic Foot InfectionsSurgical Wound InfectionAbscessCellulitis

Keywords

Complicated Skin and Soft-Tissue InfectionSkin InfectionSkin Infection RegistrycSSTI Registry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with complicated skin and soft tissue infections (specifically, diabetic foot infections, surgical site infections, deep soft tissue abscess, cellulitis)

You may qualify if:

  • Patients with a diagnosis of complicated skin and soft-tissue infection
  • Patients who require IV antibiotic therapy as a primary treatment regimen
  • Patients who are deemed to be cognitive and able to provide written informed consent and follow-up information.

You may not qualify if:

  • Patients with a diagnosis at the index infection site of necrotizing soft tissue infection, burn, gangrene, decubitus ulcer, animal or human bites, known or suspected osteomyelitis, or mediastinitis
  • Patients for whom amputation or a complete resection of the infection site is a planned component of treatment
  • Patients who are pregnant
  • Patients simultaneously participating in any interventional clinical trial
  • Patients with any other known or suspected condition that may jeopardize adherence to registry protocol requirements
  • Patients who are employees of the investigator or study hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Staphylococcal Skin InfectionsSurgical Wound InfectionAbscessCellulitisSoft Tissue Infections

Condition Hierarchy (Ancestors)

Staphylococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, BacterialSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesWound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSuppurationInflammationConnective Tissue Diseases

Study Officials

  • Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

    Ortho-McNeil Janssen Scientific Affairs, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 18, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 4, 2013

Record last verified: 2013-03