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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: September 19, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
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 Intervention
Infection Drug: Cipro (Ciprofloxacin, BAYQ3939)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Bayer:

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

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

Enrollment: 704
Study Start Date: April 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01690559

Many Locations, Japan
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Director, Bayer Yakuhin, Ltd Identifier: NCT01690559     History of Changes
Other Study ID Numbers: 16516
CIPRO-IV-2010 ( Other Identifier: company internal )
Study First Received: September 19, 2012
Last Updated: September 19, 2012

Keywords provided by Bayer:

Additional relevant MeSH terms:
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 processed this record on August 18, 2017