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.

Study Overview

• Status: Completed
• Conditions: Infection
• Intervention / Treatment: Drug: Ciprofloxacin (BAYQ3939)

• Study Type: Observational
• Enrollment (Actual): 3274

Contacts and Locations

Study Locations

• Japan
  • Many Locations, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Ciprofloxacin (BAYQ3939); Patient treated with Ciproxan as a first line treatment in daily clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: August 20, 2012
• First Posted (Estimate): August 22, 2012

Study Record Updates

• Last Update Posted (Estimate): August 28, 2012
• Last Update Submitted That Met QC Criteria: August 27, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: infection; peritonitis; pneumonia; sepsis; cholangitis; Ciprofloxacin; anthrax; cholecystitis
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 15029; CIPRO-IV-2007 (Other Identifier: company internal)