ArticleCritical care (London, England)2009
Pharmacokinetics and lung delivery of PDDS-aerosolized amikacin (NKTR-061) in intubated and mechanically ventilated patients with nosocomial pneumonia.
Article in Critical care (London, England), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01021436 (An Open-Label, Multicenter, Multinational Study to Assess the Safety,Tolerability and Pharmacokinetics of Aerosolized Amikacin Delivered Via the Pulmonary Drug Delivery System), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label, Multicenter, Multinational Study to Assess the Safety,Tolerability and Pharmacokinetics of Aerosolized Amikacin Delivered Via the Pulmonary Drug Delivery System (NKTR-061) in Intubated and Mechanically- Ventilated Patients With Nosocomial Pneumonia
Who cites it
34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 131 citations in OpenAlex.
- Aerosol delivery during invasive mechanical ventilation: a systematic review.Critical care (London, England) · 2017Pooled it
- Task force on management and prevention of Acinetobacter baumannii infections in the ICU.Intensive care medicine · 2015Guideline
- Amikacin pharmacokinetics after nebulization among intubated patients.Critical care (London, England) · 2026Trial
- SPECT-CT Comparison of Lung Deposition using a System combining a Vibrating-mesh Nebulizer with a Valved Holding Chamber and a Conventional Jet Nebulizer: a Randomized Cross-over Study.Pharmaceutical research · 2017Trial
- BAY41-6551 achieves bactericidal tracheal aspirate amikacin concentrations in mechanically ventilated patients with Gram-negative pneumonia.Intensive care medicine · 2012Trial
- Ventilator-Associated Pneumonia After Cardiac Arrest and Prevention Strategies: A Narrative Review.Medicina (Kaunas, Lithuania) · 2025Review
- Nebulized aminoglycosides for ventilator-associated pneumonia: Methodological considerations and lessons from experimental studies.Journal of intensive medicine · 2025Review
- Virtual Screening of Potential RoxS Inhibitors and Evaluation of Their Antimicrobial Activity in Combination with Antibiotics against Clinically Resistant Bacteria.Antibiotics (Basel, Switzerland) · 2023Article
- The Use of an Inspiration-Synchronized Vibrating Mesh Nebulizer for Prolonged Inhalative Iloprost Administration in Mechanically Ventilated Patients-An In Vitro Model.Pharmaceutics · 2023Article
- Inhaled amikacin for pneumonia treatment and dissemination prevention: an experimental model of severe monolateral Pseudomonas aeruginosa pneumonia.Critical care (London, England) · 2023Article
- How to Use Nebulized Antibiotics in Severe Respiratory Infections.Antibiotics (Basel, Switzerland) · 2023Review
- Aerosolized antibiotics in the treatment of hospital-acquired pneumonia/ventilator-associated pneumonia.The Korean journal of internal medicine · 2022Review
- The Unfulfilled Promise of Inhaled Therapy in Ventilator-Associated Infections: Where Do We Go from Here?Journal of aerosol medicine and pulmonary drug delivery · 2022Review
- Preclinical Evaluation of Inhalational Spectinamide-1599 Therapy against Tuberculosis.ACS infectious diseases · 2021Article
- Article
- Impact of the Epithelial Lining Fluid Milieu on Amikacin Pharmacodynamics Against Pseudomonas aeruginosa.Drugs in R&D · 2021Article
- Inhaled antibiotics during mechanical ventilation-why it will work.Annals of translational medicine · 2021Review
- Chinese guidelines for the diagnosis and treatment of hospital-acquired pneumonia and ventilator-associated pneumonia in adults (2018 Edition).Journal of thoracic disease · 2019Review
- Inhaled amikacin for severe Gram-negative pulmonary infections in the intensive care unit: current status and future prospects.Critical care (London, England) · 2018Review
- Antibacterial Activity of Human Simulated Epithelial Lining Fluid Concentrations of Ceftazidime-Avibactam Alone or in Combination with Amikacin Inhale (BAY41-6551) against Carbapenem-Resistant Pseudomonas aeruginosa and Klebsiella pneumoniae.Antimicrobial agents and chemotherapy · 2018Article
Corrections and comments
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Authors and funding
9 authors at 9 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAminoglycosides aerosolization might achieve better diffusion into the alveolar compartment than intravenous use. The objective of this multicenter study was to evaluate aerosol-delivered amikacin penetration into the alveolar epithelial lining fluid (ELF) using a new vibrating mesh nebulizer (Pulmonary Drug Delivery System (PDDS), Nektar Therapeutics), which delivers high doses to the lungs.
methodsNebulized amikacin (400 mg bid) was delivered to the lungs of 28 mechanically ventilated patients with Gram-negative VAP for 7-14 days, adjunctive to intravenous therapy. On treatment day 3, 30 minutes after completing aerosol delivery, all the patients underwent bronchoalveolar lavage in the infection-involved area and the ELF amikacin concentration was determined. The same day, urine and serum amikacin concentrations were determined at different time points.
resultsMedian (range) ELF amikacin and maximum serum amikacin concentrations were 976.1 (135.7-16127.6) and 0.9 (0.62-1.73) microg/mL, respectively. The median total amount of amikacin excreted in urine during the first and second 12-hour collection on day 3 were 19 (12.21-28) and 21.2 (14.1-29.98) microg, respectively. During the study period, daily through amikacin measurements were below the level of nephrotoxicity. Sixty-four unexpected adverse events were reported, among which 2 were deemed possibly due to nebulized amikacin: one episode of worsening renal failure, and one episode of bronchospasm.
conclusionsPDDS delivery of aerosolized amikacin achieved very high aminoglycoside concentrations in ELF from radiography-controlled infection-involved zones, while maintaining safe serum amikacin concentrations. The ELF concentrations always exceeded the amikacin minimum inhibitory concentrations for Gram-negative microorganisms usually responsible for these pneumonias. The clinical impact of amikacin delivery with this system remains to be determined.
trial registrationClinicalTrials.gov Identifier: NCT01021436.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.