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 July 2015 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: July 3, 2015
Last verified: July 2015

December 8, 2008
July 3, 2015
May 2013
January 2016   (final data collection date for primary outcome measure)
Proportion of cured patients in the BAY41-6551 group divided by the proportion of cured patients in the placebo group [ Time Frame: 17-19 days after start of treatment with study medication ] [ 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
  • 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 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 days in the hospital [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Relapse rates [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Per patient 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 ]
  • 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 ]
  • 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 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

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
650
January 2016
January 2016   (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
No
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
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
Bayer
Bayer
  • Nektar Therapeutics
  • Novartis Pharmaceuticals
Study Director: Bayer Study Director Bayer
Bayer
July 2015

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