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

Completed

• Conditions: Infection
• Interventions: Drug: Cipro (Ciprofloxacin, BAYQ3939)

• Registration Number: NCT01690559
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-09
• Study First Submitted: 2012-09-19
• Study First Submitted QC: 2012-09-19
• Last Update Submitted: 2012-09-19
• Study First Posted: 2012-09-21
• Last Update Posted: 2012-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 704

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..

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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	Cipro (Ciprofloxacin, BAYQ3939)	Patient treated with Ciproxan without dilution treatment in daily clinical practice

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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