Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

Infection Clinical Trial

Official title:

Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670435
• Other study ID #: 15029
• Secondary ID: CIPRO-IV-2007
• Status: Completed
• Phase: N/A
• First received: August 7, 2012
• Last updated: August 27, 2012
• Start date: May 2007
• Est. completion date: October 2010

Study information

• Verified date: August 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3274
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection

Intervention

Drug:
• Ciprofloxacin (BAYQ3939)
Patient treated with Ciproxan as a first line treatment in daily clinical practice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)		After 9 days	Yes
Primary	Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion		After 9 days	No
Secondary	ADR incidence rates classified by patient's background factors		After 9 days	Yes
Secondary	Efficacy rate calculated with Response and Minor Response considered as responder		After 9 days	No
Secondary	Efficacy rates classified by patient's background factors		After 9 days	No

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