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Completed

NCT Number: NCT01670435

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.

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Key information

Conditions

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

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ciprofloxacin (BAYQ3939)

Drug

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

Primary outcomes

  1. Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)

    Time frame: After 9 days

  2. Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion

    Time frame: After 9 days

Secondary outcomes

  1. ADR incidence rates classified by patient's background factors

    Time frame: After 9 days

  2. Efficacy rate calculated with Response and Minor Response considered as responder

    Time frame: After 9 days

  3. Efficacy rates classified by patient's background factors

    Time frame: After 9 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 22, 2012
Registry last updated
Aug 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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