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

Bayer logo

Bayer

Status

Completed

Conditions

Infection

Treatments

Drug: Cipro (Ciprofloxacin, BAYQ3939)

Study type

Observational

Funder types

Industry

Identifiers

NCT01690559
16516
CIPRO-IV-2010 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

704 patients

Sex

All

Ages

7+ years old

Volunteers

No Healthy Volunteers

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 design

704 participants in 1 patient group

Group 1
Description:
Patient treated with Ciproxan without dilution treatment in daily clinical practice
Treatment:
Drug: Cipro (Ciprofloxacin, BAYQ3939)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems