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Optimizing Intravenous Fosfomycin Dosing in Combination With View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Elsevier - Publisher Connector International Journal of Infectious Diseases 50 (2016) 23–29 Contents lists available at ScienceDirect International Journal of Infectious Diseases jou rnal homepage: www.elsevier.com/locate/ijid Optimizing intravenous fosfomycin dosing in combination with carbapenems for treatment of Pseudomonas aeruginosa infections in critically ill patients based on pharmacokinetic/pharmacodynamic (PK/PD) simulation a b b c a, O. Asuphon , P. Montakantikul , J. Houngsaitong , P. Kiratisin , P. Sonthisombat * a Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand b Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand c Department of Microbiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand A R T I C L E I N F O A B S T R A C T Article history: Objective: The purpose of the study was to determine the optimal dosing regimen of intravenous Received 29 March 2016 fosfomycin for the treatment of Pseudomonas aeruginosa (PA) based on PK/PD targets. Received in revised form 11 June 2016 Method: A total of 120 PA isolates were recovered from various clinical specimens at university hospital Accepted 15 June 2016 in Thailand. Minimum Inhibitory Concentrations (MICs) of all the isolates were determined by the E-test Corresponding Editor: Eskild Petersen, method. PK parameters were obtained from a published study. Monte Carlo simulation was performed to Aarhus, Denmark calculate the percentage of target attainment (PTA) and cumulative fraction of response (CFR). Results: MIC90 of fosfomycin alone, fosfomycin in combination with carbapenem, carbapenems alone Keywords: and carbapenems in combination with fosfomycin were >1,024, 1,024, >32 and 32 mg/ml, for multidrug fosfomycin resistant (MDR)-PA and 512, 128, 8 and 3 mg/ml respectively, for non-MDR PA. Approximately 40% of the Monte Carlo simulation non-MDR PA were carbapenem-resistant strains. For non-MDR PA with CRPA, fosfomycin 16 g pharmacokinetics/pharmacodynamics continuous infusion in combination with carbapenems provided %PTA of approximately 80 and %CFR of Pseudomonas aeruginosa > 88. While, %PTA and %CFR > 90 were achieved with fosfomycin 24 g/day prolonged infusion in combination with carbapenem. Conclusions: Prolonged infusion of fosfomycin 16 - 24 g combined with extended carbapenem infusion could be used in non-MDR PA treatment with CRPA. ß 2016 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by- nc-nd/4.0/). (MDR) gram-negative pathogen causing pneumonia in hospital- 1. Introduction 3 ized patients. P. aeruginosa infections have a high rate of mortality (ranging Pseudomonas aeruginosa (PA) is a highly prevalent pathogen of 1,2 from 10% to 70%) particularly in patients given inappropriate nosocomial infections worldwide. Data from developing coun- empirical therapy, immunocompromised patients, ICU patients tries indicates that P. aeruginosa is the most common cause of 4–8 and drug-resistant P. aeruginosa infections. Drug-resistant P. pneumonia in hospital (29%), and is the third most common cause 2 aeruginosa in critically ill patients poses a treatment challenge, of Intensive Care Unit (ICU)-acquired infections (17%). The with the available antibiotics of choice for this pathogen, such as situation in Thailand is similar, with P aeruginosa being the most 8–10 carbapenems, becoming gradually less effective. common pathogen of Hospital-Acquired Pneumonia (HAP) in that 3 A combination of antimicrobial agents is a good option for country. More importantly, it is a common multidrug-resistant treatment of drug-resistant P. aeruginosa infections in critically ill 11–13 patients. Colistin has already become a standard of treatment 12,13 in patients infected with drug-resistant P. aeruginosa. Howev- * Corresponding author. Department of Pharmacy Practice, Faculty of er, nephrotoxicity associated with colistin means this medicine Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand. E-mail address: [email protected] (P. Sonthisombat). should be avoided in some renal insufficiency and high risk http://dx.doi.org/10.1016/j.ijid.2016.06.017 1201-9712/ß 2016 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). 24 O. Asuphon et al. / International Journal of Infectious Diseases 50 (2016) 23–29 11,12 patients. Antibiotics together with a combination of fosfomy- required for near-maximal bactericidal effect of the dosing interval 14 37,39,40 cin and carbapenems appear to be a possible treatment regimen. for Pseudomonas aeruginosa. Intravenous (IV) fosfomycin is an old antibiotic agent which exerts excellent in vitro bactericidal activity against a wide spectrum of 2.3. Pharmacokinetic Model organisms, including P. aeruginosa, especially in resistant 14–18 strains. In in vitro studies, the combination of fosfomycin Pharmacokinetic data were obtained from previously published 41–44 with carbapenems has also shown good synergistic effects against studies of critically ill patients. A set of parameters was 19 P. aeruginosa isolates. Some clinical trials have reported randomly generated according to each mean and standard improvements in the clinical and microbiological outcomes of deviation of the parameters. Steady-state concentration versus fosfomycin in combination with other antibiotics, such as time was simulated using a one-compartment model for fosfo- 19–24 41 carbapenems, for treatment of P. aeruginosa. However, the mycin and a two-compartment model for carbapenems to 42–44 reported appropriate dosage regimen of fosfomycin varied calculate %T>MIC. widely.20–24; Pharmacokinetic/pharmacodynamic (PK/PD) studies, especially 2.4. Monte Carlo Simulation in Monte Carlo simulations, have played roles for selecting appropriate antibiotic doses with the goal of increasing treatment Pharmacodynamic/pharmacokinetic analysis was conducted efficacy and reducing the risk of selecting multidrug-resistant via a 10,000-subject Monte Carlo simulation (Crystal Ball 25–27 pathogens. Previous studies that considered antibiotic PK/PD 2010 v.2.2; Decisioneering Inc., Denver, CO) for IV dosage regimens to optimize exposure when treating resistant bacteria included of fosfomycin and carbapenems to calculate %T> MIC based on the many antimicrobial agents such as colistin and piperacillin/ linear pharmacokinetic behavior of each agent. Log-normal 28–31 tazobactam. These studies resulted in successful outcomes. distributions were evaluated for between-patient variability. The However, previous Monte Carlo simulation studies of PK/PD probability of target attainment (PTA) was calculated as the dosages did not include fosfomycin. percentage of all 10,000 estimates that had a probability of The purpose of this current study was to find the optimal dosage attaining 40% T>MIC for carbarpenems and 70% T>MIC for regimen of fosfomycin when used in combination with carbape- fosfomycin, either used alone or in combination. The cumulative nem for the treatment of non-MDR-PA and MDR-PA based on PK/ fraction of response (CFR) was calculated as the proportion of %PTA PD targets in critically ill patients. of each MIC according to the MIC distribution. The PTA and CFR 90% was considered optimal against a bacterial population, whereas a CFR between 80% and 90% was associated with 36,45 2. Materials and methods moderate probabilities of success. 2.1. Microbiology 3. Results P. aeruginosa isolates recovered from various clinical specimens MDR-PA had MIC90 >1,024 mg/ml for fosfomycin monotherapy, (sputum, urine, skin and soft tissue, blood, pleural fluid) at the 1,024 mg/ml for fosfomycin combined with carbapenems, >32 mg/ Faculty of Medicine at Siriraj Hospital in Bangkok, Thailand, were ml for carbapenems monotherapy, and 32 mg/ml for carbapenems collected between June and September 2011. A total of 120 non- combined with fosfomycin (Table 1). While, MIC90 for non-MDR PA MDR and MDR isolates were obtained. Minimum inhibitory were 512 mg/ml for fosfomycin monotherapy, 128 mg/ml for concentrations (MICs) of carbapenems (imipenem, meropenem fosfomycin combined with carbapenems, >32 mg/ml, 8 mg/ml and doripenem) and fosfomycin by E test were determined for all and 4 mg/ml for imipenem, meropenem, and doripenem mono- isolates. Isolate preparation was performed according to the therapy, respectively. For carbapenem combination, MIC90 were 32 Clinical and Laboratory Standards Institute (CLSI 2011) protocol. 12 mg/ml for imipenem combined with fosfomycin, 3 mg/ml for The MDR phenotype was identified for isolates expressing meropenem combined with fosfomycin and 2 mg/ml for doripe- resistance to at least three different antibiotic groups: beta- nem combined with fosfomycin, respectively. The doripenem lactams (penicillin, cephalosporin or carbapenems (except mono- combination with fosfomycin had a MICs lower than the other 33 bactam e.g. aztreonam), aminoglycosides and fluoroquinolones. carbapenems (Figure 1). Approximately 40% of non-MDR-PA was Synergy studies were conducted using an E test of fosfomycin in carbapenem-resistant PA (CRPA). combination with carbapenems. E test strips of
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