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Amikacin inhalation

Kenneth N Olivier, David E Griffith, Gina Eagle, John P McGinnis Ii, Liza Micioni, Keith Liu, Charles L Daley, Kevin L Winthrop, Stephen Ruoss, Doreen J Addrizzo-Harris, Patrick A Flume, Daniel Dorgan, Matthias Salathe, Barbara A Brown-Elliott, Renu Gupta, Richard J Wallace
Rationale Lengthy multi-drug, toxic, and low efficacy regimens limit management of pulmonary nontuberculous mycobacterial (PNTM) disease. Objective This phase 2 study investigated efficacy and safety of liposomal amikacin for inhalation (LAI) in treatment-refractory PNTM (Mycobacterium avium complex [MAC] or Mycobacterium abscessus) disease. Methods During the double-blind phase, patients were randomly assigned to LAI (590 mg) or placebo once daily added to their multi-drug regimen for 84 days. Both groups could receive open-label LAI for 84 additional days...
October 17, 2016: American Journal of Respiratory and Critical Care Medicine
Vladimir Malinin, Mary Neville, Gina Eagle, Renu Gupta, Walter R Perkins
BACKGROUND: Pulmonary nontuberculous mycobacterial (PNTM) infections represent a treatment challenge. Liposomal amikacin for inhalation (LAI) is a novel formulation currently in development for treatment of PNTM infections. Pulmonary deposition and elimination of LAI and its effect on macrophage function were evaluated in a series of preclinical studies in healthy rats. METHODS: Pulmonary deposition of LAI was evaluated in female rats (n = 76) treated with LAI by nebulizer at 10 mg/kg per day or 90 mg/kg per day for 27 days, followed by dosing of dual-labeled LAI (lipid label plus amikacin label) on day 28 with subsequent lung histological and amikacin analyses...
August 22, 2016: Antimicrobial Agents and Chemotherapy
Christina A Sutherland, Jamie E Verastegui, David P Nicolau
BACKGROUND: The purpose of this study was to define the potency of amikacin and comparator agents against a collection of blood and respiratory nosocomial isolates implicated in ICU based pulmonary infections gathered from US hospitals. METHODS: Minimum inhibitory concentrations of amikacin, aztreonam, cefepime, ceftazidime, ceftolozane/tazobactam, ceftriaxone, ciprofloxacin, imipenem, meropenem, piperacillin/tazobactam and tobramycin were tested against 2460 Gram-negative isolates...
2016: Annals of Clinical Microbiology and Antimicrobials
N Emiralioglu, E Yalcin, A Meral, B Sener, D Dogru, U Ozcelik, N Kiper
WHAT IS KNOWN AND OBJECTIVE: Antibiotic therapy aimed at eradicating Pseudomonas aeruginosa (Pa), and improved regimens to treat chronic Pa infection have played a major role in increasing the median survival of patients with cystic fibrosis (CF). However, different clinical centres use varying eradication regimens. The aim of this study was to evaluate the efficacy of multiple eradication treatments against initial Pa infection and to determine the factors affecting the treatment success...
August 2016: Journal of Clinical Pharmacy and Therapeutics
Jean-Bernard Michotte, Enrico Staderini, Deborah Le Pennec, Jonathan Dugernier, Rares Rusu, Jean Roeseler, Laurent Vecellio, Giuseppe Liistro, Grégory Reychler
UNLABELLED: Backround: Coupling nebulization with noninvasive ventilation (NIV) has been shown to be effective in patients with respiratory diseases. However, a breath-synchronized nebulization option that could potentially improve drug delivery by limiting drug loss during exhalation is currently not available on bilevel ventilators. The aim of this in vitro study was to compare aerosol delivery of amikacin with a vibrating mesh nebulizer coupled to a single-limb circuit bilevel ventilator, using conventional continuous (Conti-Neb) and experimental inspiratory synchronized (Inspi-Neb) nebulization modes...
August 2016: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Y S Nassar, M Ibrahim, A G Salman, T S Elgohary
No abstract text is available yet for this article.
December 2015: Intensive Care Medicine Experimental
Christopher T Campbell, Rachael McCaleb, Kalen B Manasco
OBJECTIVE: To review the current literature on inhaled antibiotic therapies currently in clinical trials for cystic fibrosis (CF) patients. DATA SOURCES: A literature search was performed using PubMed (1975 to September 2015), International Pharmaceutical Abstracts (1970 to September 2015), and MEDLINE (1946 to September 2015) to identify studies for inclusion. The following search terms were used: cystic fibrosis, inhaled amikacin, inhaled liposomal amikacin, inhaled vancomycin, and/or inhaled levofloxacin...
February 2016: Annals of Pharmacotherapy
Wonhee So, Jared L Crandon, Yukihiro Hamada, David P Nicolau
OBJECTIVES: While Amikacin Inhale (BAY41-6551), an integrated drug-device combination under development, achieves an estimated amikacin epithelial lining fluid (ELF) concentration of ∼ 5000 mg/L, its target site pharmacodynamics are unknown. We evaluated the pharmacodynamics of ELF exposure of inhaled amikacin ± meropenem. METHODS: ELF exposures of inhaled amikacin (400 mg every 12 h), intravenous meropenem (2 g every 8 h) and a combination of both were studied in an in vitro pharmacodynamic model...
February 2016: Journal of Antimicrobial Chemotherapy
Sergey Zakharov, Jan Csomor, Petr Urbanek, Daniela Pelclova
Toxic epidermal necrolysis (TEN) is a life-threatening mucocutaneous disease with high mortality. Dithiocarbamates (DTC) are organosulphur compounds widely used in agriculture, industry and households. We report a case of TEN after exposure to mancozeb in fungicide. A 48-year-old 75 kg b.w. man was admitted with fever and generalized skin/mucous lesions after application of fungicide in a home garden. The patient had necrotic desquamation of gastrointestinal/respiratory tract mucosa, ocular lesion and skin epidermolysis of 90% of body surface...
January 2016: Basic & Clinical Pharmacology & Toxicology
Silvia Belotti, Alessandra Rossi, Paolo Colombo, Ruggero Bettini, Dimitrios Rekkas, Stavros Politis, Gaia Colombo, Anna Giulia Balducci, Francesca Buttini
A Central Composite Design (CCD) was applied in order to identify positive combinations of the production parameters of amikacin sulphate spray-dried powders for inhalation, with the intent to expand the experimental space defined in a previous half-fractional factorial design. Three factors, namely drying temperature, feed rate and ethanol proportion, have been selected out of the initial five. In addition, the levels of these factors were increased from two to three and their effect on amikacin respirability was evaluated...
June 2015: European Journal of Pharmaceutics and Biopharmaceutics
Helio S Sader, Paul R Rhomberg, David J Farrell, Ronald N Jones
Arbekacin is a broad-spectrum aminoglycoside licensed for systemic use in Japan and under clinical development as an inhalation solution in the United States. We evaluated the occurrence of organisms isolated from pneumonias in U.S. hospitalized patients (PHP), including ventilator-associated pneumonia (VAP), and the in vitro activity of arbekacin. Organism frequency was evaluated from a collection of 2,203 bacterial isolates (339 from VAP) consecutively collected from 25 medical centers in 2012 through the SENTRY Antimicrobial Surveillance Program...
2015: Antimicrobial Agents and Chemotherapy
Valerie Waters, Alan Smyth
Much of the improvement in the survival of individuals with cystic fibrosis (CF) is due to advancements in antimicrobial treatments. New aerosolized antibiotic formulations have recently been introduced (such as inhaled aztreonam), and others are in development (inhaled levofloxacin and liposomal amikacin). Licensed dry powder formulations include tobramycin inhalation powder and dry powder colistimethate (available in Europe). Although inhaled antibiotics have the advantage of being able to deliver high intrapulmonary concentrations of drug, antimicrobial resistance can still develop and is a concern in CF...
September 2015: Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society
M Hoppentocht, O W Akkerman, P Hagedoorn, H W Frijlink, A H de Boer
Patients infected with pathogenic bacteria have to be treated with antibiotics. When the infection is in the lungs, as for instance in cystic fibrosis, bronchiectasis and tuberculosis, inhaled antibiotics have certain advantages over systemically administered antibiotics. In this study, it is shown that re-designing the Twincer™ high dose disposable inhaler into a device named Cyclops enables effective dispersion of up to 50mg of pure spray dried tobramycin. This proves that spray dried tobramycin powders in the preferred size range for inhalation can be administered without applying complex particle engineering techniques and/or using excipients...
February 2015: European Journal of Pharmaceutics and Biopharmaceutics
Sasha J Rose, Mary E Neville, Renu Gupta, Luiz E Bermudez
Pulmonary infections caused by nontuberculous mycobacteria (NTM) are an increasing problem in individuals with chronic lung conditions and current therapies are lacking. We investigated the activity of liposomal amikacin for inhalation (LAI) against NTM in vitro as well as in a murine model of respiratory infection. Macrophage monolayers were infected with three strains of Mycobacterium avium, two strains of Mycobacterium abscessus, and exposed to LAI or free amikacin for 4 days before enumerating bacterial survival...
2014: PloS One
Nabile Boukhettala, Thierry Porée, Patrice Diot, Laurent Vecellio
BACKGROUND: During mechanical ventilation, different aerosol generators are employed with various interfaces. The objective of this study was to evaluate the performance of a range of spacers, including a new device called Combihaler® designed for connection with both nebulizers and pressurized Metered-Dose Inhalers (pMDIs). METHODS: To assess the spacers, we used a ventilator and the Dual Adult Training and Test Lung (model 5600i, Michigan Instruments). Ventilation parameters were measured with and without spacers in volume-controlled and pressure-controlled mode...
April 2015: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Alessandra Monteiro Brodt, Elizabeth Stovold, Linjie Zhang
We conducted a meta-analysis of randomised trials to evaluate the efficacy and safety of inhaled antibiotics in patients with stable non-cystic fibrosis (CF) bronchiectasis. We searched the Cochrane Airways Group Register of Trials from inception until March 2014. 12 trials with 1264 adult patients were included, of which five were unpublished studies. Eight trials on 590 patients contributed data to the meta-analysis. Amikacin, aztreonam, ciprofloxacin, gentamicin, colistin or tobramycin were used for 4 weeks to 12 months...
August 2014: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
Silvia Belotti, Alessandra Rossi, Paolo Colombo, Ruggero Bettini, Dimitrios Rekkas, Stavros Politis, Gaia Colombo, Anna Giulia Balducci, Francesca Buttini
An amikacin product for convenient and compliant inhalation in cystic fibrosis patients was constructed by spray-drying in order to produce powders of pure drug having high respirability and flowability. An experimental design was applied as a statistical tool for the characterization of amikacin spray drying process, through the establishment of mathematical relationships between six Critical Quality Attributes (CQAs) of the finished product and five Critical Process Parameters (CPPs). The surface-active excipient, PEG-32 stearate, studied for particle engineering, in general did not benefit the CQAs of the spray dried powders for inhalation...
August 25, 2014: International Journal of Pharmaceutics
Valerie Waters, Felix Ratjen
Arikace™ is a novel formulation of inhaled liposomal amikacin that can penetrate deep within airway secretions and within Pseudomonas aeruginosa biofilms, making it an attractive therapeutic option for the treatment of cystic fibrosis (CF) pulmonary infections. Initial Phase I and Phase II studies in CF patients with chronic P. aeruginosa infection demonstrated that Arikace™ was a safe drug that resulted in significant improvements in lung function after 14-28 days of treatment. Phase III studies of inhaled liposomal amikacin compared to tobramycin inhalation solution in CF patients with P...
August 2014: Expert Review of Respiratory Medicine
A Bruce Montgomery, Paul R Rhomberg, Tammy Abuan, Kathie-Anne Walters, Robert K Flamm
The amikacin-fosfomycin inhalation system (AFIS), a combination of antibiotics administered with an in-line nebulizer delivery system, is being developed for adjunctive treatment of ventilator-associated pneumonia (VAP). The in vitro characterization of amikacin-fosfomycin (at a 5:2 ratio) described here included determining resistance selection rates for pathogens that are representative of those commonly associated with VAP (including multidrug-resistant strains) and evaluating interactions with antibiotics commonly used intravenously to treat VAP...
July 2014: Antimicrobial Agents and Chemotherapy
A Bruce Montgomery, Paul R Rhomberg, Tammy Abuan, Kathie-Anne Walters, Robert K Flamm
The amikacin-fosfomycin inhalation system (AFIS) is a combination of 2 antibiotics and an in-line nebulizer delivery system that is being developed for adjunctive treatment of pneumonia caused by Gram-negative organisms in patients on mechanical ventilation. AFIS consists of a combination of amikacin and fosfomycin solutions at a 5:2 ratio (amikacin, 3 ml at 100 mg/ml; fosfomycin, 3 ml at 40 mg/ml) and the PARI Investigational eFlow Inline System. In this antibiotic potentiation study, the antimicrobial activities of amikacin and fosfomycin, alone and in a 5:2 combination, were assessed against 62 Gram-negative pathogens from a worldwide antimicrobial surveillance collection (SENTRY)...
July 2014: Antimicrobial Agents and Chemotherapy
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