NCT00786305

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2004

Typical duration for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
Last Updated

November 6, 2008

Status Verified

November 1, 2008

Enrollment Period

3.9 years

First QC Date

November 5, 2008

Last Update Submit

November 5, 2008

Conditions

Pneumonia

Keywords

NebulizationceftazidimeamikacinpneumoniaPseudomonas aeruginosamechanical ventilationVentilator-associated pneumoniatreatment

Outcome Measures

Primary Outcomes (1)

  • Bacterial killing

    14 days

Secondary Outcomes (1)

  • Changes of lung aeration

    8 days

Study Arms (2)

1: nebulized ceftazidime and amikacin

EXPERIMENTAL
Drug: ceftazidime and amikacin

2: intravenous ceftazidime and amikacin

ACTIVE COMPARATOR
Drug: ceftazidime and amikacin

Interventions

ceftazidime and amikacinDRUG

Nebulized ceftazidime 15 mg/kg/3h during 8 days and nebulized amikacin 25 mg/kg/day during 3 days

Also known as: fortum and amiklin
1: nebulized ceftazidime and amikacin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive care unit, Department of anesthesiology, La pitie-Salpetriere hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

PneumoniaPseudomonas InfectionsPneumonia, Ventilator-Associated

Interventions

CeftazidimeAmikacin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesHealthcare-Associated PneumoniaCross InfectionIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CephaloridineCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsKanamycinAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Jean-Jacques Rouby, MD, PhD

    La Pitie-Salpetriere hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 6, 2008

Study Start

October 1, 2004

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

November 6, 2008

Record last verified: 2008-11

Locations

FR(1)