Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481689
Status:
COMPLETED
Last Update Posted:
2009-06-26
First Post:
2007-06-01
Brief Title:
Study To Evaluate The Efficacy And Safety Of Ciprofloxacin Extended-Release Cipro XR 1000 mg Tablets Given Once Daily For 7 To 14 Days In The Treatment Of Patients 18 Years Or Older With Complicated Urinary Tract Infections Caused By Pseudomonas Aeruginosa And Other Common Uropathogens
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Prospective Open-Label Noncomparative Multicenter Study to Evaluate the Efficacy and Safety of Ciprofloxacin Extended Release Cipro XR 1000 mg Tablets Given Once Daily for 7 to 14 Days in the Treatment of Patients 18 Years or Older With Complicated Urinary Tract Infections Caused by Pseudomonas Aeruginosa and Other Common Uropathogens
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Researchers want to find out if a drug called Cipro XR ciprofloxacin extended-release can help people with a complicated urinary tract infection caused by a kind of bacteria called Pseudomonas aeruginosa The study doctor will give Cipro XR to some people to see if it is safe and works to treat complicated urinary tract infections caused by Pseudomonas aeruginosa The study doctor will also gather information about using Cipro XR to treat complicated urinary tract infections caused by other bacteria About 500 people with complicated urinary tract infections who are 18 years old and older will join this study Cipro XR is approved by the US Food and Drug Administration FDA for the treatment of complicated urinary tract infections and acute uncomplicated pyelonephritis inflammation of the kidney The dose of Cipro XR used in this study 1000 mg a day for 7 to 14 days has been shown to be safe and effective This study is being done to gather more information on using this dose of Cipro XR for complicated urinary tract infections caused by Pseudomonas aeruginosa as well as by other bacteria
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None