Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-02-12 @ 4:16 AM
Study NCT ID:
NCT00737269
Status:
COMPLETED
Last Update Posted:
2013-03-04
First Post:
2008-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Complicated Skin and Soft-tissue Infection Patient Registry
Sponsor:
Ortho-McNeil Janssen Scientific Affairs, LLC
Organization:
Study Overview
Official Title:
A Prospective, Multi-center, Observational Registry Involving Patients Hospitalized With Complicated Skin and Soft Tissue Infections (cSSTI) for IV Antibiotic Therapy
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
A prospective, multi-center, observational study involving 1200 patients hospitalized for the treatment of cSSTIs. The study will be conducted at approximately 50 hospitals in the US. Patients who consent to participate in the registry will be enrolled in the registry within 24 hours of initial IV antibiotic therapy for treatment of one or more cSSTI types. Sites will treat patients according to their usual clinical practice. The objective of this registry is to characterize cSSTIs with respect to patient characteristics and describe patient outcomes.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CEFTOSSK4001 | OTHER | Ortho-McNeil Janssen Scientific Affairs, LLC | View |