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

NCT01670435 | Completed

• 2 other identifiers: 15029CIPRO-IV-2007
• Study Type: observational
• Target: 3,274
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

Ciprofloxacin; sepsis; infection; pneumonia; peritonitis; cholecystitis; cholangitis; anthrax

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

Group 1

Drug: Ciprofloxacin (BAYQ3939)

Interventions

Ciprofloxacin (BAYQ3939) DRUG

Patient treated with Ciproxan as a first line treatment in daily clinical practice

Group 1

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who are contraindicated based on the product label.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Japan

Location

MeSH Terms

Conditions

Infections; Sepsis; Pneumonia; Peritonitis; Cholecystitis; Cholangitis; Anthrax

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Intraabdominal Infections; Peritoneal Diseases; Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Bile Duct Diseases; Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 22, 2012
• Study Start: May 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 28, 2012

Record last verified: 2012-08

Locations

JP (1)