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:
Bayer
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
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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:
MedlinePlus related topics:
Pneumonia
Drug Information available for:
Amikacin sulfate
U.S. FDA Resources
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
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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013