Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution

Study Overview
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Brief Summary
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This study is a post-marketing surveillance in Japan to investigate the safety especially focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv administration without dilution in the daily practice.It is a local prospective and observational study of patients who have received Ciproxan intravenously for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. A total of 500 patients are to be enrolled and assessed during the period of treatment with Ciproxan.

Conditions
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Infection

Intervention / Treatment
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* Drug: Cipro (Ciprofloxacin, BAYQ3939)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - The mentioned bellow patients caused by the following bacteria which are sensitive to this drug: Indicated microorganisms:Staphylococcus, Enterococcus, Bacillus anthracis, Escherichia coli, Klebsiella , Enterobacter, Pseudomonas aeruginosa, Legionella. Indications: Sepsis, Secondary skin infections (superficial burn, operative wounds, trauma), Pneumonia, Peritonitis, Cholecystitis, Cholangitis, Anthrax The patients treated with this drug without dilution due to strict restriction of fluid intake. In hospitalized patients who retain consciousness ,and at the same time who are able to report (such as vascular pain) side effects.. Exclusion Criteria: Patients who are contraindicated based on the product label.

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patient treated with Ciproxan without dilution treatment in daily clinical practice | Drug: Cipro (Ciprofloxacin, BAYQ3939)<br>* Patient treated with Ciproxan without dilution treatment in daily clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs) |  | After 8 days | 
| Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion |  | After 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADR incidence rates classified by patient's background factors |  | After 8 days | 
| Efficacy rate calculated with Response and Minor Response considered as responder |  | After 8 days | 
| Efficacy rates classified by patient's background factors |  | After 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, pneumonia, peritonitis, Ciprofloxacin, sepsis, cholecystitis, cholangitis, anthrax