Trial Condition(s):
Infection
Ciprofloxacin Special Drug Use Investigation - To investigate the safety and efficacy in patients with ciprofloxacin iv administration without dilution
Bayer Identifier:
16516
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)Timeframe: After 8 days
- Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretionTimeframe: After 8 days
Secondary Outcome
- ADR incidence rates classified by patient’s background factorsTimeframe: After 8 days
- Efficacy rate calculated with Response and Minor Response considered as responderTimeframe: After 8 days
- Efficacy rates classified by patient’s background factorsTimeframe: After 8 days
Additional Information
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