Trial Condition(s):

Infection

Ciprofloxacin Special Drug Use Investigation - To investigate the safety and efficacy in patients with ciprofloxacin iv administration without dilution

Bayer Identifier:

16516

ClinicalTrials.gov Identifier:

NCT01690559

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
704
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Cipro IV (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Completed
 

Trial Design