Trial Condition(s):
Pneumonia
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)
Bayer Identifier:
AMIK-04-02
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial 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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site San Antonio, United States, 78229 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winston-Salem, United States, 27157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United States, 35233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Melbourne, United States, 32901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albany, United States, 12208 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Paris Cedex 14, France, 75674 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Paris Cedex 13, France, 75651 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Limoges Cedex, France, 87046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Paris Cedex 15, France, 75908 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Angers Cedex 9, France, 49933 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rouen cedex, France, 76031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Paris, France, 75018 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Murcia, Spain, 30120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- 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 1Timeframe: Day 1
Secondary Outcome
- Mean C(max) and mean AUC of amikacin in tracheal aspiratesTimeframe: Day 1 and Day 3 of treatment period
- Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MICTimeframe: Day 1 and Day 3 of treatment period
- Clinical cure rateTimeframe: Test of cure visit (7 days post last treatment dose)
- Microbiological eradication rate of identified pathogensTimeframe: Test of cure visit (7 days post last treatment dose)
- Microbiological persistence rateTimeframe: Test of cure visit (7 days post last treatment dose)
- New infection rateTimeframe: Test of cure visit (7 days post last treatment dose)
- Assessment of adverse events related to drug or deviceTimeframe: Treatment period, early post treatment period, test of cure visit, and late post treatment
- Assessment of abnormal laboratory valuesTimeframe: Treatment period, early post treatment period, test of cure visit, and late post treatment
Additional Information
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