Overview

Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Ciprofloxacin
Criteria
Inclusion Criteria:

- - The mentioned bellow patients caused by the following bacteria which are sensitive
to this drug: Indicated microorganisms:Staphylococcus, Enterococcus, Bacillus
anthracis, Escherichia coli, Klebsiella , Enterobacter, Pseudomonas aeruginosa,
Legionella. Indications: Sepsis, Secondary skin infections (superficial burn,
operative wounds, trauma), Pneumonia, Peritonitis, Cholecystitis, Cholangitis, Anthrax

- The patients treated with this drug without dilution due to strict restriction of
fluid intake.

- In hospitalized patients who retain consciousness ,and at the same time who are able
to report (such as vascular pain) side effects..

Exclusion Criteria:

- Patients who are contraindicated based on the product label.