Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

Bayer

Status: Completed

Conditions: Infection

Treatments: Drug: Ciprofloxacin (BAYQ3939)

Study type: Observational

Funder types: Industry

Identifiers

NCT01670435

CIPRO-IV-2007 (Other Identifier)

15029

Details and patient eligibility

About

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.

Enrollment: 3,274 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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 design

3,274 participants in 1 patient group

Group 1

Treatment:

Drug: Ciprofloxacin (BAYQ3939)