Trial Condition(s):

Infection

Assessment of the safety and efficacy of Ciproxan-I.V. in daily clinical practice - Analysis results from a post-marketing surveillance

Bayer Identifier:

15029

ClinicalTrials.gov Identifier:

NCT01670435

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A total of 3,000 patients are to be enrolled and assessed during the period of treatment with Ciproxan.

Inclusion Criteria
- Patients who received Ciproxan as a first-line treatment were eligible for the study, among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug.
Exclusion Criteria
- Patients who are contraindicated based on the product label.

Trial Summary

Enrollment Goal
3274
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