Assessment of the Safety and Efficacy of Ciproxan-I.V. in... | NCT01670435

Studies
Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

NCT01670435

Sponsor

Bayer

Status

Completed

Last Update Posted

Aug 28, 2012Estimated

Enrollment

3,274Actual

Phase

Not provided

Conditions

Infection

Interventions

Ciprofloxacin (BAYQ3939)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CIPRO-IV-2007	Other Identifier	company internal

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jun 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Aug 7, 2012

First Submission Date that Met QC Criteria

Aug 20, 2012

First Posted Date

Aug 22, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2012

Last Update Posted Date

Aug 28, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A total of 3,000 patients are to be enrolled and assessed during the period of treatment with Ciproxan.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,274Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Ciprofloxacin (BAYQ3939)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ciprofloxacin (BAYQ3939)	Drug	Patient treated with Ciproxan as a first line treatment in daily clinical practice	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)		After 9 days
Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion		After 9 days

Secondary Outcomes

Measure	Description	Time Frame
ADR incidence rates classified by patient's background factors		After 9 days
Efficacy rate calculated with Response and Minor Response considered as responder		After 9 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who received Ciproxan as a first-line treatment were eligible for the study, 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.

Exclusion Criteria:

Patients who are contraindicated based on the product label.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who received Ciproxan as a first-line treatment were eligible for the study, 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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D018805	Sepsis
D011014	Pneumonia
D010538	Peritonitis
D002764	Cholecystitis
D002761	Cholangitis
D000881	Anthrax

Ancestor Terms

ID	Term
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002939	Ciprofloxacin

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

Browse Leaves

Not provided

Browse Branches

Not provided