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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01690559
First received: September 19, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted

September 19, 2012
September 19, 2012
April 2010
January 2012   (final data collection date for primary outcome measure)
  • Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs) [ Time Frame: After 8 days ] [ Designated as safety issue: Yes ]
  • Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion [ Time Frame: After 8 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • ADR incidence rates classified by patient's background factors [ Time Frame: After 8 days ] [ Designated as safety issue: Yes ]
  • Efficacy rate calculated with Response and Minor Response considered as responder [ Time Frame: After 8 days ] [ Designated as safety issue: No ]
  • Efficacy rates classified by patient's background factors [ Time Frame: After 8 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution
Not Provided

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Infection
Drug: Cipro (Ciprofloxacin, BAYQ3939)
Patient treated with Ciproxan without dilution treatment in daily clinical practice
Group 1
Patient treated with Ciproxan without dilution treatment in daily clinical practice
Intervention: Drug: Cipro (Ciprofloxacin, BAYQ3939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
704
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01690559
16516, CIPRO-IV-2010
No
Medical Director, Bayer Yakuhin, Ltd
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP