check_circleStudy Completed

Infection

Bayer Identifier:

16516

ClinicalTrials.gov Identifier:

NCT01690559

EudraCT Number:

Not Available

EU CT Number:

Not Available
Ciprofloxacin Special Drug Use Investigation - To investigate the safety and efficacy in patients with ciprofloxacin iv administration without dilution

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.

Key Participants Requirements

Sex

Both

Age

7 - N/A
  • - - 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..

  • - Patients who are contraindicated based on the product label.

Trial summary

Enrollment Goal
704
Trial Dates
April 2010 - January 2012
Phase
N/A
Could I Receive a placebo
No
Products
Cipro IV (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)
    date_rangeTime Frame:
    After 8 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion
    date_rangeTime Frame:
    After 8 days
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    Safety Issue:
    No

Secondary Outcome

  • ADR incidence rates classified by patient’s background factors
    date_rangeTime Frame:
    After 8 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Efficacy rate calculated with Response and Minor Response considered as responder
    date_rangeTime Frame:
    After 8 days
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    Safety Issue:
    No
  • Efficacy rates classified by patient’s background factors
    date_rangeTime Frame:
    After 8 days
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    Safety Issue:
    No

Trial design

Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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