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

NCT ID: NCT01690559

Last Updated: 2012-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

704 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-01-31

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.

Detailed Description

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Conditions

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Infection

Keywords

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Ciprofloxacin sepsis infection pneumonia peritonitis cholecystitis cholangitis anthrax

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patient treated with Ciproxan without dilution treatment in daily clinical practice

Cipro (Ciprofloxacin, BAYQ3939)

Intervention Type DRUG

Patient treated with Ciproxan without dilution treatment in daily clinical practice

Interventions

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Cipro (Ciprofloxacin, BAYQ3939)

Patient treated with Ciproxan without dilution treatment in daily clinical practice

Intervention Type DRUG

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.
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Yakuhin, Ltd

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CIPRO-IV-2010

Identifier Type: OTHER

Identifier Source: secondary_id

16516

Identifier Type: -

Identifier Source: org_study_id