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)

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01004445

Enrollment

Registered

2009-10-30

Start date

2005-05-31

Completion date

2006-06-30

Last updated

2011-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Keywords

Pneumonia, Adjunctive treatment, Gram-negative bacteria

Brief 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).

Interventions

DRUGAmikacin (BAY41-6551)

Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule

DRUGPlacebo

Two aerosol treatments per day (one treatment every 12hr)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC	Day 1 and Day 3 of treatment period
Clinical cure rate	Test of cure visit (7 days post last treatment dose)
Microbiological eradication rate of identified pathogens	Test of cure visit (7 days post last treatment dose)
Mean C(max) and mean AUC of amikacin in tracheal aspirates	Day 1 and Day 3 of treatment period
New infection rate	Test of cure visit (7 days post last treatment dose)
Assessment of adverse events related to drug or device	Treatment period, early post treatment period, test of cure visit, and late post treatment
Assessment of abnormal laboratory values	Treatment period, early post treatment period, test of cure visit, and late post treatment
Microbiological persistence rate	Test of cure visit (7 days post last treatment dose)

Countries

France, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026