Trial Condition(s):
Infection
Assessment of the safety and efficacy of Ciproxan-I.V. in daily clinical practice - Analysis results from a post-marketing surveillance
Bayer Identifier:
15029
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)Timeframe: After 9 days
- Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretionTimeframe: After 9 days
Secondary Outcome
- ADR incidence rates classified by patient’s background factorsTimeframe: After 9 days
- Efficacy rate calculated with Response and Minor Response considered as responderTimeframe: After 9 days
- Efficacy rates classified by patient’s background factorsTimeframe: After 9 days
Additional Information
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