Aerosolized antibiotics and ventilator-associated tracheobronchitis in the intensive care unit*

Palmer, Lucy B.; Smaldone, Gerald C.; Chen, John J.; Baram, Daniel; Duan, Tao; Monteforte, Melinda; Varela, M. Arroyo; Tempone, Ann K.; O’Riordan, Thomas G.; Daroowalla, Feroza; Richman, Paul

doi:10.1097/ccm.0b013e31817c0f9e

Cited by 228 publications

(216 citation statements)

References 24 publications

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“…(1,2) Adjunctive aerosol antibiotic therapy to treat Gram-negative pneumonia in patients on mechanical ventilation has been studied for over 30 years with encouraging results; however, multicenter, placebocontrolled, randomized trials are needed to establish which antibiotics and drug delivery systems are most efficacious. (3)(4)(5)(6)(7)(8) The emergence of highly resistant Gram-negative bacteria has increased the amount of aminoglycoside required for a 1 Cardeas Pharma, Seattle, WA. 2 Alfred Hospital, Melbourne, Australia.…”

Section: Introductionmentioning

confidence: 99%

A Randomized Double-Blind Placebo-Controlled Dose-Escalation Phase 1 Study of Aerosolized Amikacin and Fosfomycin Delivered via the PARI Investigational eFlow^® Inline Nebulizer System in Mechanically Ventilated Patients

Ab¹,

Vallance²,

Abuan³

et al. 2014

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Background: This clinical trial evaluated the pharmacokinetics and safety/tolerability of amikacin/fosfomycin solution using a vibrating plate nebulizer, in mechanically ventilated patients with ventilator-associated tracheobronchitis (VAT) or ventilator-associated pneumonia (VAP). Methods: Nine adult patients were consented to receive three escalating doses of a combination of 50 mg/mL amikacin and 20 mg/mL fosfomycin; doses were separated by 24 -2 hr. On day 3, patients received two blinded, randomized treatments (amikacin/fosfomycin and volume-matched placebo), separated by 2 hr. All treatments were administered with a single-patient, multitreatment nebulizer (Investigational eFlow Ò Inline Nebulizer System; PARI Pharma GmbH, positioned in the inspiratory limb tubing between the ventilator and the patient. The nebulizer remained in-line until all treatments had been delivered. Concentrations of amikacin and fosfomycin were measured in tracheal aspirate and plasma samples obtained during the 24 hr after each dose. Results: Fifteen minutes after dosing with the 300/120 mg amikacin/fosfomycin combination, tracheal aspirate amikacin concentrations -SD were 12,390 -3,986 lg/g, and fosfomycin concentrations were 6,174 -2,548 lg/g (n¼6). Airway clearance was rapid. Plasma concentrations were subtherapeutic; the highest observed amikacin plasma concentration was 1.4 lg/mL, and the highest observed fosfomycin plasma concentration was 0.8 lg/mL. Administration time was approximately 2 min/mL. No adverse effects on respiratory rate, peak airway pressures, or oxygenation were observed during or following drug or placebo administration. Conclusions: High tracheal aspirate concentrations of amikacin and fosfomycin were achieved in mechanically ventilated patients with VAT or VAP after aerosolized administration with an inline nebulizer system. Airway clearance was rapid. No adverse respiratory effects were noted during or following drug administration.

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Section: Introductionmentioning

confidence: 99%

A Randomized Double-Blind Placebo-Controlled Dose-Escalation Phase 1 Study of Aerosolized Amikacin and Fosfomycin Delivered via the PARI Investigational eFlow^® Inline Nebulizer System in Mechanically Ventilated Patients

Ab¹,

Vallance²,

Abuan³

et al. 2014

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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“…Inhaled antibiotics can be given to reduce the risk of ventilator associated respiratory infections (Palmer et al, 2008). More research should be done in the future to know the local resistance patterns of the isolates causing ventilator associated respiratory infections.…”

Section: Resultsmentioning

confidence: 99%

A Study of Incidence and Microbiological Profile of Ventilator Associated Tracheobronchitis (VAT) in a Tertiary Care Hospital

Devi¹,

Gomathi²

2018

Int.J.Curr.Microbiol.App.Sci

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“…Two small randomised trials evaluated the impact of antimicrobials on patients with VAT. In a study of 43 patients with VAT randomised to either aerosolized antimicrobials or placebo, Palmer and colleagues demonstrated reduced incidence of subsequent VAP in those receiving antimicrobials, though there was no difference in ICU length of stay or mortality between groups (Palmer LB, 2008). In contrast, when comparing systemic antimicrobials versus placebo for the treatment of VAT, Nseir and colleagues showed a survival benefit in those receiving antimicrobial therapy .…”

Section: Bodymentioning

confidence: 97%

23rd International Symposium on Infections in the Critically Ill Patient

et al. 2018

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IntroductionThis 23rd International Symposium on Infections in the Critically Ill Patient aims to review current concepts, technology and present advances in infections in critically ill patient.Sepsis, Pulmonary Infections and their therapeutic and preventive strategies will be the topics presented by international experts who will review and update sepsis as a global international problem. New guidelines of Surviving Sepsis campaign, fluid therapy and vassopressors, a balance view between personalization and protocol treatment and new recommendations for the design of future randomized control trials are provided. The immune response and the emerging methods to personalize sepsis care including new biomarkers and immunomonitoring of patients with sepsis represent a new complementary view to treat patients with severe infections and organ failure in addition to early antibiotic and the control of source of infection.New ways to treat pulmonary infections including the new global guidelines and the international actions against multiresistant microorganisms and the development of new antibiotics represent key factors to improve the outcome of severe infections. antibiotics, fluid resuscitation, blood pressure targets and so forth fails to account for the individualized needs of the patient. Sepsis is not a specific disease entity but an umbrella syndrome covering a range of biological phenotypes. Therapies should thus be selected and dose-adjusted accordingly, taking into account the individual host's phenotype, underlying comorbidities, and the site and source of infection. A one-size-fits-all, brain-stem, heavily protocolized approach will suit the lowest common denominator. Surely we should seek loftier ambitions based on education, an increased depth of understanding, enhanced monitoring and diagnostics, and a personalized approach incorporating evidence and clinical expertise. This concept of EBID (evidence-based individualized decision-making) is not new; indeed, it was enshrined by none other than David Sackett, a pioneer of evidence-based medicine who railed against rigid adoption of evidence: "Clinicians who fear top down cookbooks will find the advocates of evidence -based medicine joining them at the barricades". Ignacio Do We Need New Clinical Design for RCT? Jean-Louis VincentDepartment of Intensive Care, Erasme Hospital, Université libre de Bruxelles, Brussels, BelgiumAbstract: The prospective randomized controlled trial (RCT) has been widely promoted as the only effective means of definitively proving the superiority of one intervention over another. However, in the intensive care unit (ICU) population, RCTs can be challenging to conduct, and results have rarely demonstrated beneficial effects of the intervention under investigation on outcomes. The main reason for this lack of success is the heterogeneous nature of the critically ill populations included in these studies. Ethical issues can also be a problem in the ICU as patients are frequently not able to give consent and surrogates may not be ...

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Aerosolized antibiotics and ventilator-associated tracheobronchitis in the intensive care unit*

Abstract: In critically ill patients with ventilator-associated tracheobronchitis, AA decrease VAP and other signs and symptoms of respiratory infection, facilitate weaning, and reduce bacterial resistance and use of systemic antibiotics.

Cited by 228 publications

References 24 publications

A Randomized Double-Blind Placebo-Controlled Dose-Escalation Phase 1 Study of Aerosolized Amikacin and Fosfomycin Delivered via the PARI Investigational eFlow^® Inline Nebulizer System in Mechanically Ventilated Patients

A Randomized Double-Blind Placebo-Controlled Dose-Escalation Phase 1 Study of Aerosolized Amikacin and Fosfomycin Delivered via the PARI Investigational eFlow^® Inline Nebulizer System in Mechanically Ventilated Patients

A Study of Incidence and Microbiological Profile of Ventilator Associated Tracheobronchitis (VAT) in a Tertiary Care Hospital

23rd International Symposium on Infections in the Critically Ill Patient

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Aerosolized antibiotics and ventilator-associated tracheobronchitis in the intensive care unit*

Abstract: In critically ill patients with ventilator-associated tracheobronchitis, AA decrease VAP and other signs and symptoms of respiratory infection, facilitate weaning, and reduce bacterial resistance and use of systemic antibiotics.

Cited by 228 publications

References 24 publications

A Randomized Double-Blind Placebo-Controlled Dose-Escalation Phase 1 Study of Aerosolized Amikacin and Fosfomycin Delivered via the PARI Investigational eFlow® Inline Nebulizer System in Mechanically Ventilated Patients

A Randomized Double-Blind Placebo-Controlled Dose-Escalation Phase 1 Study of Aerosolized Amikacin and Fosfomycin Delivered via the PARI Investigational eFlow® Inline Nebulizer System in Mechanically Ventilated Patients

A Study of Incidence and Microbiological Profile of Ventilator Associated Tracheobronchitis (VAT) in a Tertiary Care Hospital

23rd International Symposium on Infections in the Critically Ill Patient

Contact Info

Product

Resources

About

A Randomized Double-Blind Placebo-Controlled Dose-Escalation Phase 1 Study of Aerosolized Amikacin and Fosfomycin Delivered via the PARI Investigational eFlow^® Inline Nebulizer System in Mechanically Ventilated Patients

A Randomized Double-Blind Placebo-Controlled Dose-Escalation Phase 1 Study of Aerosolized Amikacin and Fosfomycin Delivered via the PARI Investigational eFlow^® Inline Nebulizer System in Mechanically Ventilated Patients