Ciprofloxacin on Burned Patients | NCT00668044

Studies
Ciprofloxacin on Burned Patients

NCT00668044

Sponsor

Bayer

Status

Completed

Last Update Posted

Oct 27, 2009Estimated

Enrollment

18Actual

Phase

Phase 3

Conditions

Burns
Bacterial Infections

Interventions

Ciprofloxacin (BAYO9867)
Ciprofloxacin (BAYO9867)

Countries

Italy

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
COB

Status Module

Record Verification Date

Oct 2009

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

Nov 2002

Primary Completion Date

Nov 2003Actual

Completion Date

Nov 2003Actual

First Submitted Date

Apr 24, 2008

First Submission Date that Met QC Criteria

Apr 27, 2008

First Posted Date

Apr 28, 2008Estimated

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

Oct 26, 2009

Last Update Posted Date

Oct 27, 2009Estimated

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 was a non randomised, multi center, italian study performed in burn patients receiving an antibiotic (ciprofloxacin) in order to treat an active infection. The aim of the study was to validate a pharmacokinetics model useful to verify if a standard dose regimen of ciprofloxacin, given to patients with a compromised metabolism, is a correct dose or instead is over or under dosed.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Ciprofloxacin (BAYO9867)
Arm 2	Experimental		Drug: Ciprofloxacin (BAYO9867)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ciprofloxacin (BAYO9867)	Drug	400 mg iv BID	Arm 1
Ciprofloxacin (BAYO9867)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model		>72 h post injury, 48h and 120 h after treatment

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio		>72 h post injury, 48h and 120 h after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Moderate to severe burnt patients defined as burning of 20 to 60% of total body surface according to rule of nine, II deep degree and III degree according to Full-Thickness Burn model,
Hospitalization for burning injury since at least 72h during hyper metabolic phase
Active infections microbiological confirmed
Signed informed consent

Exclusion Criteria:

Pregnant or lactating female patients
Previous history of tendinopathy
Knowing syndrome of QTc prolongation
Impairment renal function
Hepatic insufficiency
Convulsion
Limited life expectancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D002056	Burns
D001424	Bacterial Infections

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D001423	Bacterial Infections and Mycoses
D007239	Infections

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

Facility	Status	City	State	ZIP	Country	Contacts
		Cesena	Forlì	47023	Italy