check_circleStudy Completed

Infection

Bayer Identifier:

15029

ClinicalTrials.gov Identifier:

NCT01670435

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of the safety and efficacy of Ciproxan-I.V. in daily clinical practice - Analysis results from a post-marketing surveillance

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

7 - N/A
  • - 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.

  • - Patients who are contraindicated based on the product label.

Trial summary

Enrollment Goal
3274
Trial Dates
May 2007 - October 2010
Phase
N/A
Could I Receive a placebo
No
Products
Cipro IV (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)
    date_rangeTime Frame:
    After 9 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion
    date_rangeTime Frame:
    After 9 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • ADR incidence rates classified by patient’s background factors
    date_rangeTime Frame:
    After 9 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Efficacy rate calculated with Response and Minor Response considered as responder
    date_rangeTime Frame:
    After 9 days
    enhanced_encryption
    Safety Issue:
    No
  • Efficacy rates classified by patient’s background factors
    date_rangeTime Frame:
    After 9 days
    enhanced_encryption
    Safety Issue:
    No

Trial design

Assessment of the safety and efficacy of Ciproxan-I.V. in daily clinical practice - Analysis results from a post-marketing surveillance
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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