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Completed

NCT Number: NCT01004445

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)

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).

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amikacin (BAY41-6551)

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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

    Time frame: Day 1

Secondary outcomes

  1. Mean C(max) and mean AUC of amikacin in tracheal aspirates

    Time frame: Day 1 and Day 3 of treatment period

  2. Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC

    Time frame: Day 1 and Day 3 of treatment period

  3. Clinical cure rate

    Time frame: Test of cure visit (7 days post last treatment dose)

  4. Microbiological eradication rate of identified pathogens

    Time frame: Test of cure visit (7 days post last treatment dose)

  5. Microbiological persistence rate

    Time frame: Test of cure visit (7 days post last treatment dose)

  6. New infection rate

    Time frame: Test of cure visit (7 days post last treatment dose)

  7. Assessment of adverse events related to drug or device

    Time frame: Treatment period, early post treatment period, test of cure visit, and late post treatment

  8. Assessment of abnormal laboratory values

    Time frame: Treatment period, early post treatment period, test of cure visit, and late post treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Nektar Therapeutics

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 30, 2009
Registry last updated
Apr 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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