NCT01690559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
704

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
Last Updated

September 21, 2012

Status Verified

September 1, 2012

Enrollment Period

1.8 years

First QC Date

September 19, 2012

Last Update Submit

September 19, 2012

Conditions

Infection

Keywords

Ciprofloxacinsepsisinfectionpneumoniaperitonitischolecystitischolangitisanthrax

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

Group 1

Patient treated with Ciproxan without dilution treatment in daily clinical practice

Drug: Cipro (Ciprofloxacin, BAYQ3939)

Interventions

Cipro (Ciprofloxacin, BAYQ3939)DRUG

Patient treated with Ciproxan without dilution treatment in daily clinical practice

Group 1

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received Ciproxan iv administration without dilution in the daily practice among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug.

You may qualify if:

  • \- 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..

You may not qualify if:

  • Patients who are contraindicated based on the product label.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Japan

Location

MeSH Terms

Conditions

InfectionsSepsisPneumoniaPeritonitisCholecystitisCholangitisAnthrax

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIntraabdominal InfectionsPeritoneal DiseasesDigestive System DiseasesGallbladder DiseasesBiliary Tract DiseasesBile Duct DiseasesBacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 21, 2012

Study Start

April 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 21, 2012

Record last verified: 2012-09

Locations

JP(1)