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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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01670435
First received: August 7, 2012
Last updated: August 27, 2012
Last verified: August 2012

August 7, 2012
August 27, 2012
May 2007
June 2010   (final data collection date for primary outcome measure)
  • Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs) [ Time Frame: After 9 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 9 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01670435 on ClinicalTrials.gov Archive Site
  • ADR incidence rates classified by patient's background factors [ Time Frame: After 9 days ] [ Designated as safety issue: Yes ]
  • Efficacy rate calculated with Response and Minor Response considered as responder [ Time Frame: After 9 days ] [ Designated as safety issue: No ]
  • Efficacy rates classified by patient's background factors [ Time Frame: After 9 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance
Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

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.

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

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.

Infection
Drug: Ciprofloxacin (BAYQ3939)
Patient treated with Ciproxan as a first line treatment in daily clinical practice
Group 1
Intervention: Drug: 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
3274
October 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01670435
15029, CIPRO-IV-2007
No
Medical Director, Bayer Yakuhin, Ltd.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
August 2012

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