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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01690559

Enrollment

704

Registered

2012-09-21

Start date

2010-04-30

Completion date

2012-01-31

Last updated

2012-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

Ciprofloxacin, sepsis, infection, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax

Brief summary

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.

Interventions

DRUGCipro (Ciprofloxacin, BAYQ3939)

Patient treated with Ciproxan without dilution treatment in daily clinical practice

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)	After 8 days
Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion	After 8 days

Secondary

Measure	Time frame
ADR incidence rates classified by patient's background factors	After 8 days
Efficacy rate calculated with Response and Minor Response considered as responder	After 8 days
Efficacy rates classified by patient's background factors	After 8 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026