A Study to Determine the Correct Dose of Amikacin Which is Delivered Directly to the Lungs of Ventilated Patients as an Aerosol Via an Investigational Device Called the Pulmonary Delivery Device System (PDDS)

Pneumonia Clinical Trial

Official title:

A Double-Blind, Placebo-controlled Parallel Group, Phase II Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System (PDDS) in Ventilated Patients With Nosocomial Pneumonia Due to Gram Negative Organisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004445
• Other study ID #: AMIK-04-02
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2009
• Last updated: April 7, 2011
• Start date: May 2005
• Est. completion date: June 2006

Study information

• Verified date: April 2011
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Agence Francaise de Securite Sanitaire des Produits de SanteSpain: Agencia Espanola de Medicamentos y Productos sanitanos
• Study type: Interventional

Clinical Trial Summary

This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients 18 years of age or older with a clinical diagnosis of VAP, HAP or HCAP who are expected to be on mechanical ventilation for at least 3 days

Exclusion Criteria:

• Patients with compromised of suppressed immune systems, severe hypoxemia, PEEP>15cm H2O, creatinine>2 mg/dL, or who are pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• Amikacin (BAY41-6551)
Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule
• Amikacin (BAY41-6551)
Daily dose of 800 mg aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment every 12hr
• Placebo
Two aerosol treatments per day (one treatment every 12hr)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Nektar Therapeutics

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who achieve a C(max) for amikacin in tracheal aspirates at least 25 times greater than the reference MIC for hospital-acquired organisms and an AUC (0-24 hr) / MIC ratio that is 100 or greater on Day 1		Day 1	No
Secondary	Mean C(max) and mean AUC of amikacin in tracheal aspirates		Day 1 and Day 3 of treatment period	No
Secondary	Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC		Day 1 and Day 3 of treatment period	No
Secondary	Clinical cure rate		Test of cure visit (7 days post last treatment dose)	No
Secondary	Microbiological eradication rate of identified pathogens		Test of cure visit (7 days post last treatment dose)	No
Secondary	Microbiological persistence rate		Test of cure visit (7 days post last treatment dose)	No
Secondary	New infection rate		Test of cure visit (7 days post last treatment dose)	No
Secondary	Assessment of adverse events related to drug or device		Treatment period, early post treatment period, test of cure visit, and late post treatment	Yes
Secondary	Assessment of abnormal laboratory values		Treatment period, early post treatment period, test of cure visit, and late post treatment	Yes

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