Infection
Conditions
Keywords
Ciprofloxacin, sepsis, infection, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax
Brief summary
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.
Interventions
DRUGCiprofloxacin (BAYQ3939)
Patient treated with Ciproxan as a first line treatment in daily clinical practice
Sponsors
Bayer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs) | After 9 days |
| Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion | After 9 days |
Secondary
| Measure | Time frame |
|---|---|
| ADR incidence rates classified by patient's background factors | After 9 days |
| Efficacy rate calculated with Response and Minor Response considered as responder | After 9 days |
| Efficacy rates classified by patient's background factors | After 9 days |
Countries
Japan
Outcome results
None listed