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

Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690559
• Other study ID #: 16516
• Secondary ID: CIPRO-IV-2010
• Status: Completed
• Phase: N/A
• First received: September 19, 2012
• Last updated: September 19, 2012
• Start date: April 2010
• Est. completion date: January 2012

Study information

• Verified date: September 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection

Intervention

Drug:
• Cipro (Ciprofloxacin, BAYQ3939)
Patient treated with Ciproxan without dilution 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 8 days	Yes
Primary	Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion		After 8 days	No
Secondary	ADR incidence rates classified by patient's background factors		After 8 days	Yes
Secondary	Efficacy rate calculated with Response and Minor Response considered as responder		After 8 days	No
Secondary	Efficacy rates classified by patient's background factors		After 8 days	No

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