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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01670435

Collaborator

(none)

3,274

Enrollment

Location

Duration (Months)

79.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: Ciprofloxacin (BAYQ3939)

Study Design

Study Type:

Observational

Actual Enrollment :

3274 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: Ciprofloxacin (BAYQ3939) Patient treated with Ciproxan as a first line treatment in daily clinical practice

Arm

Intervention/Treatment

Group 1

Drug: Ciprofloxacin (BAYQ3939)

Patient treated with Ciproxan as a first line treatment in daily clinical practice

Outcome Measures

Primary Outcome Measures

Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs) [After 9 days]
Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion [After 9 days]

Secondary Outcome Measures

ADR incidence rates classified by patient's background factors [After 9 days]
Efficacy rate calculated with Response and Minor Response considered as responder [After 9 days]
Efficacy rates classified by patient's background factors [After 9 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.