NCT00861315

Brief Summary

Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine the dose of amikacin to be nebulized in order to observe amikacin serum concentrations close to but inferior to those observed after standart intravenous amikacin infusion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 16, 2009

Status Verified

March 1, 2009

Enrollment Period

2 years

First QC Date

March 12, 2009

Last Update Submit

March 13, 2009

Conditions

Ventilator Associated Pneumonia

Keywords

PneumoniaNebulizationAmikacin

Outcome Measures

Primary Outcomes (1)

  • Determintion of nebulized amikacin dose (60 mg/Kg, 80 mg/Kg or 100 mg/Kg) which results in serum amikacin concentrations equal or below the serum amikacin concentrations measured after 20 mg/Kg intravenous amikacin infusion

Secondary Outcomes (4)

  • Comparison of clinical pulmonary infection score evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin

    10 days

  • Comparison of serum procalcitonin concentration evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin

    10 days

  • Comparison of c reactive protein evolution between patients treated with nebulized amikacin and patients treated with intravenous amikacin

    10 days

  • Comparison duration of mechanical ventilation between patients treated with nebulized amikacin and patients treated with intravenous amikacin

    10 days

Study Arms (2)

Nebulized amikacin

EXPERIMENTAL

Patients receive nebulized amikacin once a day during three days. Placebo is administered intravenousely

Drug: Nebulized amikacinDrug: Placebo infusion

Intravenous amikacin

ACTIVE COMPARATOR
Drug: Intravenous amikacinDrug: Placebo nebulization

Interventions

Nebulized amikacinDRUG

Amikacin is nebulized at a dose of 60 mg/Kg (6 first patients of the arm), 80 mg/Kg (6 subsequent patients) or 100 mg/Kg (last 6 patients of the arm)

Nebulized amikacin
Intravenous amikacinDRUG

20 mg/Kg amikacin are administred intravenousely once a day during three days.

Intravenous amikacin
Placebo nebulizationDRUG

0.9% saline solution is nebulized once a day during three days

Intravenous amikacin
Placebo infusionDRUG

0.9% saline is administered intravenousely once a day during three days

Nebulized amikacin

Eligibility Criteria

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

You may qualify if:

  • Patients admitted to intensive care unit.
  • Patients undergoing mechanical ventilation for more than 48H.
  • Suspicion of ventilator associated pneumonia.

You may not qualify if:

  • Allergy to amikacin or any compound of the medication.
  • Body mass index \> 30 kg/m2.
  • Myasthenia gravis.
  • Acute or chronic renal failure.
  • Vestibulo-cochlear disease.
  • Pregnancy.
  • Brain death.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de réanimation médicale polyvalente. Hôpital Bretonneau CHRU

Tours, Indre et Loire, F37044, France

RECRUITING

Service de réanimation médicale. Hôpital La Source. CH Orléans

Orléans, Loiret, F45067, France

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-AssociatedPneumonia

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Stephan Ehrmann, MD

CONTACT

+33(0)671103302stephanehrmann@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 16, 2009

Record last verified: 2009-03

Locations

FR(2)