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- | amikacin inhalation solution (NKTR-061) / Nektar Therapeutics
PK/PD data, Preclinical, Journal: Pharmacodynamics of inhaled amikacin (BAY 41-6551) studied in an in vitro pharmacokinetic model of infection. (Pubmed Central) - Jun 28, 2019
If MIC values were related to bacterial clearance then at least a static effect or -1 log drop in count would be expected for bacterial strains with MICs of ≤180 mg/L (static effect) or ≤148 mg/L (-1 log drop effect). An fAUC/MIC amikacin target of 50-80 is appropriate for aerobic Gram-negative bacilli and mean ELF concentrations of BAY 41-6551 would produce a static to -1 log clearance with strains up to 128 mg/L.
- meropenem / Generic mfg., Daewon Pharmaceutical
Inhaled amikacin in association with systemic meropenem reduces proximal airways bacterial burden and hinders antibiotic resistance in a swine model of monolateral MDR Pseudomonas aeruginosa pneumonia () - Apr 5, 2019 - Abstract #ECCMID2019ECCMID_2327;
In a swine model of monolateral MDR P. aeruginosa pneumonia, the use of inhaled amikacin as adjuvant treatment improves only proximal airways bacterial eradication and hinders antibiotic resistance. Grant Acknowledgment: BayerAG,Germany
- meropenem / Generic mfg., Daewon Pharmaceutical
Effect of inhaled amikacin within endotracheal tubes biofilm from pigs with severe Pseudomonas aeruginosa pneumonia () - Apr 5, 2019 - Abstract #ECCMID2019ECCMID_839;
Differences were found among groups in PA ETT biofilm burden (p=0.039). Specifically, the lowest PA burden was found in IAMK+ IV-MERO (0.00 [0.00-2.13]) versus CONTROL (6.04 [4.36-6.72]) and vs IV-MERO (3.69 [1.63-6.87]) groups, p=0.014 and p=0.068, respectively.
- ||||| amikacin inhalation solution (NKTR-061) / Nektar Therap
Enrollment change, Gram negative: INHALE 1: Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia (clinicaltrials.gov) - Jul 23, 2018
P3, N=725, Completed, Sponsor: Bayer
Specifically, the lowest PA burden was found in IAMK+ IV-MERO (0.00 [0.00-2.13]) versus CONTROL (6.04 [4.36-6.72]) and vs IV-MERO (3.69 [1.63-6.87]) groups, p=0.014 and p=0.068, respectively. N=264 --> 725
- ||||||| amikacin inhalation solution (NKTR-061) / Nektar Therap
Trial completion, Enrollment change, Gram negative: INHALE 1: Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia (clinicaltrials.gov) - May 8, 2017
P3, N=264, Completed, Sponsor: Bayer
N=264 --> 725 Recruiting --> Completed | N=724 --> 264
- |||| amikacin inhalation solution (NKTR-061) / Nektar Therap
Trial primary completion date, Gram negative: Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia (clinicaltrials.gov) - Oct 6, 2015
P3, N=650, Recruiting, Sponsor: Bayer
Recruiting --> Completed | N=724 --> 264 Trial primary completion date: Jan 2016 --> Apr 2017
- |||||||||| amikacin inhalation solution (NKTR-061) / Nektar Therap
New P3 trial, Gram negative: Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia (clinicaltrials.gov) - Feb 25, 2013
P3, N=650, Recruiting, Sponsor: Bayer