Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance
- Registration Number
- NCT01670435
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3274
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.
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Exclusion Criteria
- Patients who are contraindicated based on the product label.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Ciprofloxacin (BAYQ3939) -
- Primary Outcome Measures
Name Time Method 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
Name Time Method ADR incidence rates classified by patient's background factors After 9 days Efficacy rates classified by patient's background factors After 9 days Efficacy rate calculated with Response and Minor Response considered as responder After 9 days