Nebulized Ceftazidime and Amikacin in Ventilator Associat... | NCT00786305

Studies
Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

NCT00786305

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Status

Completed

Last Update Posted

Nov 6, 2008Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Pneumonia

Interventions

ceftazidime and amikacin
ceftazidime and amikacin

Countries

France

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

Status Module

Record Verification Date

Nov 2008

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

Oct 2004

Primary Completion Date

Sep 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Nov 5, 2008

First Submission Date that Met QC Criteria

Nov 5, 2008

First Posted Date

Nov 6, 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

Nov 5, 2008

Last Update Posted Date

Nov 6, 2008Estimated

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

Pseudomonas aeruginosa is one of the major causative microorganisms of ventilator-associated pneumonia often resistant to antibiotics. In experimental models, nebulization of antibiotics delivers high lung tissue concentrations of antibiotics in infected lungs and increases lung bacterial killing. The aim of the study is to assess the efficiency of nebulized ceftazidime and amikacin in the treatment of pneumonia caused by Pseudomonas aeruginosa in ventilated patients.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1: nebulized ceftazidime and amikacin	Experimental		Drug: ceftazidime and amikacin
2: intravenous ceftazidime and amikacin	Active Comparator		Drug: ceftazidime and amikacin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ceftazidime and amikacin	Drug	Nebulized ceftazidime 15 mg/kg/3h during 8 days and nebulized amikacin 25 mg/kg/day during 3 days	1: nebulized ceftazidime and amikacin

Measure	Description	Time Frame
Bacterial killing		14 days

Measure	Description	Time Frame
Changes of lung aeration		8 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female >18 years old, ventilator associated pneumonia caused by pseudomonas aeruginosa
Written informed consent provided by the relatives

Exclusion Criteria:

Pseudomonas aeruginosa resistant to ceftazidime and amikacin
Pseudomonas aeruginosa pneumonia associated with other infections requiring intravenous treatment
Severe septic shock and severe hypoxemia
Allergy to ceftazidime or amikacin

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Jacques Rouby, MD, PhD	La Pitie-Salpetriere hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensive care unit, Department of anesthesiology, La pitie-Salpetriere hospital		Paris		75013	France

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia
D011552	Pseudomonas Infections
D053717	Pneumonia, Ventilator-Associated

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002442	Ceftazidime
D000583	Amikacin

Ancestor Terms

ID	Term
D002509	Cephaloridine
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams

Browse Leaves

Not provided

Browse Branches

Not provided