Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-06 @ 5:48 AM
Study NCT ID:
NCT01690559
Status:
COMPLETED
Last Update Posted:
2012-09-21
First Post:
2012-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-09
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:
This study is a post-marketing surveillance in Japan to investigate the safety especially focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv administration without dilution in the daily practice.It is a local prospective and observational study of patients who have received Ciproxan intravenously for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. A total of 500 patients are to be enrolled and assessed during the period of treatment with Ciproxan.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CIPRO-IV-2010 | OTHER | company internal | View |