Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia (INHALE 2)
This study is not yet open for participant recruitment.
Verified May 2013 by Bayer
Sponsor:
Bayer
Collaborators:
Nektar Therapeutics
Novartis Pharmaceuticals
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00805168
First received: December 8, 2008
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
To evaluate the efficacy and safety of adjunctive aerosolized BAY 41-6551 (amikacin inhalation solution) versus aerosolized placebo in the treatment of intubated and mechanically ventilated adult patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia, Bacterial |
Drug: Amikacin Inhalation Solution (BAY41-6551) Drug: Aerosolized Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients With Gram-Negative Pneumonia |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Clinical response at the Test-of-Cure (TOC) visit in the modified Intent-to-Treat (ie, ITT population plus a pre-therapy culture positive for a Gram-negative respiratory tract pathogen and an APACHE II score of at least 10) population. [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of days on mechanical ventilation through the Day 28 visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
- Total number of days of Gram-negative IV antibiotics per patient [ Time Frame: 17-19 days and then 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
- Number of intensive care unit (ICU) days at the Day 28 visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
- Number of hospital days at the Day 28 visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
- Clinical relapse rates at the Day 28 visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
- Per pathogen microbiological response rates at the TOC visit [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
- Per patient microbiological response rates at the TOC visit [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
- Microbiological recurrence rates at the TOC and Day 28 Visit [ Time Frame: 17-19 days and then 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
- Emergence of new potential respiratory pathogens during the treatment period. [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
- Emergence of resistance among baseline pathogens in those patients with persistent infection or colonization [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
- Number of patients who have received at least one dose of study drug and reported an adverse event [ Time Frame: After patient has signed Informed Consent until they have ended participation on the Study ] [ Designated as safety issue: Yes ]
- Mortality during the treatment period, Day 15, and Day 28 visit [ Time Frame: 17-19 days and then 28-32 days after start of treatment with study medication ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 649 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Amikacin Inhalation Solution (BAY41-6551)
400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
|
| Placebo Comparator: Arm 2 |
Drug: Aerosolized Placebo
Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and non-pregnant, non-lactating females, 18 years of age or older
- Intubated and mechanically-ventilated pneumonia- Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph
- Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions
- Signs of infection
- Impaired oxygenation
- CPIS of at least 6
- At least two risk factors for multi-drug resistant organisms
Exclusion Criteria:
- History of hypersensitivity to amikacin or other aminoglycosides
- Has received antibiotic therapy for Gram-negative pneumonia for greater than 24 hours at the time of randomization
- Primary lung cancer (including patients with small cell lung carcinoma/non-small cell lung carcinoma and patients with unknown histology) or another malignancy metastatic to the lungs or other known endobronchial obstructions Exception: Please note that patients with complete resection of non-small cell lung carcinoma are eligible for the study.
- Known or suspected active tuberculosis, cystic fibrosis, human immunodeficiency virus (HIV) infection with CD 4 count < 200 cell/mm3, or invasive fungal infection of the lung, lung abscess, or empyema
- Known or suspected bacteremia secondary to Staphylococcus aureus
- Has had a stroke within five days
- A positive urine and/or serum beta-hCG pregnancy test
- Burns greater than 40% of total body surface area
- Patients with a serum creatinine > 2 mg/dL (177 µmol/L) Exception: Patients with a serum creatinine > 2 mg/dL (177 umol/L) and being treated with continuous renal replacement therapy (CVVH and CVVH-D) or daily hemodialysis will receive the aerosol study drug treatment
- Neutropenia (Screening ANC < 103 neutrophils/mm3), stem cell transplant
- Has been on mechanical ventilation for > 28 days
- Is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment
- The risk of rapidly fatal illness and death within 72 hrs, or any concomitant condition not related to VAP that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy
- Stem cell transplantation
- Patients with documented Legionella infection (eg, Legionella pneumonia)
- Has an APACHE II score < 10
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805168
Show 135 Study Locations
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
| Contact: For trial location information (Phone Menu Options '3' or '4') | (+)1-888-84 22937 |
Show 135 Study LocationsSponsors and Collaborators
Bayer
Nektar Therapeutics
Novartis Pharmaceuticals
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00805168 History of Changes |
| Other Study ID Numbers: | 13085, 2008-000906-35 |
| Study First Received: | December 8, 2008 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United Kingdom: Department of Health Belgium: Institutional Review Board Germany: Ethics Commission France: Ministry of Health Italy: Ministry of Health Spain: Ministry of Health Czech Republic: Ethics Committee Poland: Ministry of Health Switzerland: Swiss Agency for Theraputic Products Hungary: National Institute of Pharmacy Netherlands: Medical Ethics Review Committee (METC) Norway: Norwegian Medicines Agency (Statens legemiddelverk, NOMA)Russia: Ethics Committee Ukraine: Ministry of Health China: Ministry of Health Greece: Ethics Committee Israel: Ministry of Health Japan: Institutional Review Board Turkey: Ministry of Health Portugal: The National Institute of Pharmacy and Medicines (Infarmed) |
Keywords provided by Bayer:
|
Gram-negative Pneumonia Pneumonia Intubation Mechanical ventilation Amikacin |
Additional relevant MeSH terms:
|
Pneumonia, Bacterial Pneumonia Bacterial Infections 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 23, 2013