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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 has been completed.
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01004445
First received: October 29, 2009
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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).


Condition Intervention Phase
Pneumonia
Drug: Amikacin (BAY41-6551)
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean C(max) and mean AUC of amikacin in tracheal aspirates [ Time Frame: Day 1 and Day 3 of treatment period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical cure rate [ Time Frame: Test of cure visit (7 days post last treatment dose) ] [ Designated as safety issue: No ]
  • Microbiological eradication rate of identified pathogens [ Time Frame: Test of cure visit (7 days post last treatment dose) ] [ Designated as safety issue: No ]
  • Microbiological persistence rate [ Time Frame: Test of cure visit (7 days post last treatment dose) ] [ Designated as safety issue: No ]
  • New infection rate [ Time Frame: Test of cure visit (7 days post last treatment dose) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Assessment of abnormal laboratory values [ Time Frame: Treatment period, early post treatment period, test of cure visit, and late post treatment ] [ Designated as safety issue: Yes ]

Enrollment: 69
Study Start Date: May 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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
Experimental: Arm 2 Drug: Amikacin (BAY41-6551)
Daily dose of 800 mg aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment every 12hr
Placebo Comparator: Arm 3 Drug: Placebo
Two aerosol treatments per day (one treatment every 12hr)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004445

Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, Florida
Melbourne, Florida, United States, 32901
United States, New York
Albany, New York, United States, 12208
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
France
Angers Cedex 9, France, 49933
Limoges Cedex, France, 87046
Paris, France, 75018
Paris Cedex 13, France, 75651
Paris Cedex 14, France, 75674
Paris Cedex 15, France, 75908
Rouen cedex, France, 76031
Spain
Barcelona, Spain, 08003
Barcelona, Spain, 08036
Madrid, Spain, 28040
Madrid, Spain, 28034
Madrid, Spain, 28805
Murcia, Spain, 30120
Sponsors and Collaborators
Bayer
Nektar Therapeutics
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Head Clinical Pharmacology, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01004445     History of Changes
Other Study ID Numbers: AMIK-04-02
Study First Received: October 29, 2009
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration
France: Agence Francaise de Securite Sanitaire des Produits de Sante
Spain: Agencia Espanola de Medicamentos y Productos sanitanos

Keywords provided by Bayer:
Pneumonia
Adjunctive treatment
Gram-negative bacteria

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amikacin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014