Study Completed

Infection

Bayer Identifier:

15029

ClinicalTrials.gov Identifier:

NCT01670435

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Both

Age

7 - N/A

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

May 2007 - October 2010

Phase

N/A

Could I Receive a placebo

Products

Cipro IV (Ciprofloxacin, BAYQ3939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Japan

Primary Outcome

Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)
Time Frame:
After 9 days
Safety Issue:
Yes
Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion
Time Frame:
After 9 days
Safety Issue:
No

Secondary Outcome

ADR incidence rates classified by patient’s background factors
Time Frame:
After 9 days
Safety Issue:
Yes
Efficacy rate calculated with Response and Minor Response considered as responder
Time Frame:
After 9 days
Safety Issue:
No
Efficacy rates classified by patient’s background factors
Time Frame:
After 9 days
Safety Issue:
No

Trial design

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

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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