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Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

NCT ID: NCT01670435

Last Updated: 2012-08-28

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

3274 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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

Ciprofloxacin (BAYQ3939)

Intervention Type DRUG

Patient treated with Ciproxan as a first line treatment in daily clinical practice

Interventions

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Ciprofloxacin (BAYQ3939)

Patient treated with Ciproxan as a first line treatment in daily clinical practice

Intervention Type DRUG

Eligibility Criteria

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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.

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-2007

Identifier Type: OTHER

Identifier Source: secondary_id

15029

Identifier Type: -

Identifier Source: org_study_id