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Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia (INHALE 2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Bayer
Sponsor:
Collaborators:
Nektar Therapeutics
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00805168
First received: December 8, 2008
Last updated: November 15, 2016
Last verified: November 2016

December 8, 2008
November 15, 2016
May 2013
April 2017   (final data collection date for primary outcome measure)
Proportion of patients deemed to be clinical successes in the BAY41-6551 treatment group divided by the proportion of cured patients in the placebo treatment group [ Time Frame: Late follow-up (LFU) visit (day 28-32) ] [ Designated as safety issue: No ]
The Primary efficacy variable will be the 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 respiratory tract pathogen) population [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00805168 on ClinicalTrials.gov Archive Site
  • Pneumonia-related mortality through the LFU visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Early Clinical Response which is based on CPIS scores, the presence of empyema or lung abscess, and all-cause mortality [ Time Frame: Assessed through day 10 ] [ Designated as safety issue: No ]
    Early Clinical Response success occurs if there is no rise of 2 points or more on Day 3, and a drop of 1 or more points on Day 5 and a drop 2 or more points on Day 10, and the absence of lung abscess or empyema by Day 10, and alive on Day 10.
  • Number of days on mechanical ventilation through the LFU visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Number of days in the ICU through the LFU visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Number of patients who received at least one dose of study drug and reported an adverse event [ Time Frame: 35-39 days after start of treatment with study medication ] [ Designated as safety issue: Yes ]
  • Number of patients who received at least one dose of study drug and reported a serious adverse event [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: Yes ]
  • Progression and incidence rates of organ failure [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: Yes ]
  • All-cause mortality rate [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: Yes ]
  • Identification of laboratory data outside normal ranges [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: Yes ]
  • Per pathogen microbiological response rates at the Test-of-Cure (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 LFU visits [ Time Frame: 17-19 days and 28-32 days respectively after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Emergence of new respiratory pathogens during the aerosol treatment period [ Time Frame: Days 1-10 ] [ Designated as safety issue: No ]
  • Emergence of resistance among baseline pathogens in those patients with persistent infection or colonization [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • 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 ]
  • Number of IV antibiotics per patient per day used at the TOC and Day 28 visits [ 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, number of hospital days at the Day 28 visit, 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 ]
  • Mortality during the treatment period, Day 15, and Day 28 visit [ Time Frame: Days 1-10 (treatment period), Day 15 and then Days 28-32 after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Per pathogen microbiological response rates at the TOC visit per patient microbiological response rate 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 Emergence of new potential respiratory pathogens during the treatment period, 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 ]
Not Provided
Not Provided
 
Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
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
To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pneumonia, Bacterial
  • 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)
  • Drug: Aerosolized Placebo
    Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
  • Experimental: Arm 1
    Intervention: Drug: Amikacin Inhalation Solution (BAY41-6551)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Aerosolized Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
724
April 2017
April 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and non-pregnant, non-lactating females, 18 years of age or older
  • Intubated and mechanically-ventilated
  • 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, or suspected Gram-negative pathogen
  • Impaired oxygenation
  • Clinical Pulmonary Infection Score (CPIS) of at least 6
  • Presence of or 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 48 hours at the time of randomization
  • Known or suspected bacteremia secondary to Staphylococcus aureus
  • A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test
  • 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 (Continuous Veno-Venous Hemodialysis and CVVHemoDiafiltration) or daily hemodialysis will receive the aerosol study drug treatment]
  • 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 ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy
  • Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score < 10
  • Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V ECMO)
Both
18 Years and older   (Adult, Senior)
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayer.com
Belgium,   Bulgaria,   China,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Spain,   Switzerland,   Ukraine,   United Kingdom
 
NCT00805168
13085, 2008-000906-35
Yes
Not Provided
Not Provided
Bayer
Bayer
  • Nektar Therapeutics
  • Novartis Pharmaceuticals
Study Director: Bayer Study Director Bayer
Bayer
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP