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

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ClinicalTrials.gov Identifier: NCT01690559
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : September 21, 2012
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Infection Drug: Cipro (Ciprofloxacin, BAYQ3939)

Study Type : Observational
Actual Enrollment : 704 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : April 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1
Patient treated with Ciproxan without dilution treatment in daily clinical practice
Drug: Cipro (Ciprofloxacin, BAYQ3939)
Patient treated with Ciproxan without dilution treatment in daily clinical practice



Primary Outcome Measures :
  1. Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs) [ Time Frame: After 8 days ]
  2. Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion [ Time Frame: After 8 days ]

Secondary Outcome Measures :
  1. ADR incidence rates classified by patient's background factors [ Time Frame: After 8 days ]
  2. Efficacy rate calculated with Response and Minor Response considered as responder [ Time Frame: After 8 days ]
  3. Efficacy rates classified by patient's background factors [ Time Frame: After 8 days ]


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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who received Ciproxan iv administration without dilution in the daily practice 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690559


Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Medical Director, Bayer Yakuhin, Ltd
ClinicalTrials.gov Identifier: NCT01690559     History of Changes
Other Study ID Numbers: 16516
CIPRO-IV-2010 ( Other Identifier: company internal )
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: September 21, 2012
Last Verified: September 2012

Keywords provided by Bayer:
Ciprofloxacin
sepsis
infection
pneumonia
peritonitis
cholecystitis
cholangitis
anthrax

Additional relevant MeSH terms:
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors