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Completed

NCT Number: NCT01690559

Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution

This study is a post-marketing surveillance in Japan to investigate the safety especially focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv administration without dilution in the daily practice.It is a local prospective and observational study of patients who have received Ciproxan intravenously for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. A total of 500 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

  • - The mentioned bellow patients caused by the following bacteria which are sensitive to this drug: Indicated microorganisms:Staphylococcus, Enterococcus, Bacillus anthracis, Escherichia coli, Klebsiella , Enterobacter, Pseudomonas aeruginosa, Legionella. Indications: Sepsis, Secondary skin infections (superficial burn, operative wounds, trauma), Pneumonia, Peritonitis, Cholecystitis, Cholangitis, Anthrax
  • The patients treated with this drug without dilution due to strict restriction of fluid intake.
  • In hospitalized patients who retain consciousness ,and at the same time who are able to report (such as vascular pain) side effects..

Exclusion criteria

  • Patients who are contraindicated based on the product label.

Treatment and study plan

Cipro (Ciprofloxacin, BAYQ3939)

Drug

Patient treated with Ciproxan without dilution treatment in daily clinical practice

Primary outcomes

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

    Time frame: After 8 days

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

    Time frame: After 8 days

Secondary outcomes

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

    Time frame: After 8 days

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

    Time frame: After 8 days

  3. Efficacy rates classified by patient's background factors

    Time frame: After 8 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 21, 2012
Registry last updated
Sep 21, 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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