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Two cases from the placebo group, 3 from the Cefazolin group and 3 from the Levofloxacin group failed to follow-up. Six patients (2 non-following the protocol, 2 severe depression, and 2 laparoscopic surgery) from the placebo group, 14 (8 nonreceiving trial medication, 5 laparoscopic surgery, and 1 failure to tolerance) from the Cefazolin group, and 12 (2 combination of antibiotic usage, 5 laparoscopic surgery and 5 failure to tolerance) from the Levofloxacin group were excluded. The data of the 1,160 cases were statistically analyzed in the incidence rates of surgical-site infection and complications after inguinal hernia repair. Surgical-site infection including wound infection, cellulitis or mesh-related infection was found in 20 cases (5.1%) of the control group, 15 (3.92%) of the Cefazolin group and 17 (4.42%) of the Levofloxacin group, and the difference among the three groups was not statistically significant (χ2 = 0.438, p = 0.803). There was also no significant difference in post-surgery complications including seroma (p = 0.6366), urinary retention (p = 0.8136), fat liquefaction (p = 0.8061), pulmonary infection (p = 0.1911), and urinary tract infection (p = 0.8144) among the three groups.
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Out of 110 TBM patients screened, 57 fulfilled the inclusion criteria. Their median age was 35 (15-75) years. 29 patients received RHZEL and 28 RHZE. The baseline clinical, biochemical and MRI characteristics were similar in the two groups. At 6 months, 11 (19.3%) patients died, 38 (66.7%) had good and 7 (12.3%) poor outcome. There was insignificant survival benefit in RHZEL group compared to RHZE (HR-2.61, 95% CI 0.73-9.36, P = 0.14), 25% patients died in RHZE where as 13.8% in RHZEL group. The disability was not significantly different between the two groups. The composite side effects were also similar between the two groups except for a higher frequency of seizure in RHZEL group (5 Vs 0) which resulted in withdrawal of levofloxacin.
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All isolates from 2000-2008 and 2013-2014 were identified as ST2, whereas isolates from the 1970s were ST1. PtxA2/ptxC1/ptxP1/prn1/fim2-1/fim3-1/tcfA2, which was the same as the vaccine strain, was the only type in the 1970s. During the 2000s and 2013-2014, the virulence type ptxA1/ptxC1/ptxP1/prn1/fim2-1/fim3-1/tcfA2 was dominant, with frequencies of 68.4% and 91.9%, respectively. Nine ptxP3 strains, which were more virulent, were detected after 2000. All 124 isolates were susceptible to levofloxacin, sulphamethoxazole/trimethoprim and tetracycline. The isolates from the 1970s and 2000-2008 were susceptible to all tested macrolides, whereas 91.9% of the 2013-2014 isolates were highly resistant (minimal inhibitory concentration, MIC >256 μg/ml). No ptxP3 strain was resistant to macrolides. All erythromycin-resistant strains except for one had the A2047G mutation in the 23S rRNA gene.
The survey was completed by 69 clinical pharmacists who had 8.5 ± 7.5 (mean ± SD) years of experience. All pharmacists had experience dosing medications for patients receiving RRT. The most frequently recommended regimen for each antibiotic was: cefepime 1000 mg every 24 h, ceftaroline 200 mg every 12 h, daptomycin 6 mg/kg every 24 h, levofloxacin 500 mg every 24 h, meropenem 1000 mg every 12 h, and piperacillin/tazobactam 2250 mg every 8 h. Up to nine distinct regimens were recommended for each antibiotic, and the total daily dose between these regimens ranged by as much as a 12-fold. Neither pharmacist’s experience with SLED, post-graduate training, nor years of clinical experience were significantly associated with particular dosing recommendations for the antibiotics.
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Although epithelial lining fluid (ELF) is the presumed site for pulmonary infections, most antibiotic penetration studies are conducted in uninfected patients or healthy volunteers. Levofloxacin concentrations in plasma and ELF were collected from two previous studies involving 18 infected patients with acute exacerbations of chronic bronchitis and 15 uninfected elderly patients undergoing diagnostic bronchoscopy. Concentration data were population modelled using the BigNPAG algorithm, and a 5000-patient Monte Carlo simulation was conducted to simulate ELF exposure for a dosing regimen 750mg every 24h for five doses in plasma and ELF of infected versus uninfected patients. Mean±S.D. model parameters for plasma in infected patients were similar to uninfected patients (volume of central compartment, 68.4±36.3 vs. 50.2±17.3L; clearance, 6.0±2.5 vs. 6.8±3.3L/h; and absorption rate, 5.4±2.5 vs. 4.7±2.7h(-1)), resulting in similar simulated AUC in plasma (infected, 140.5±54.8 vs. uninfected, 133.7±61.6μgh/mL). The volume of ELF was 57.2±25.0 and 14.8±9.0L in infected and uninfected patients, respectively, resulting in a lower simulated AUCELF exposure for infected patients (189.1±210.5 vs. 461.0±558.7μgh/mL). Penetration ratios for infected and uninfected patients were, respectively, 1.4±1.8 and 3.5±3.7, with median values of 0.9 and 2.4. ELF penetration in infected patients was approximately one-half that of uninfected adults. These data highlight the importance of confirming exposure in infected patients to further support dosage regimen selection.
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The emergence of MDR-TB and XDR-TB has complicated TB treatment success. Among many factors that contribute to the development of resistance, low drug exposure is not the least important. This review summarizes the available information on pharmacokinetic properties of levofloxacin in relation to microbial susceptibilities, in order to optimize the dose and make general treatment recommendations. A total of 37 studies on adult (32 studies) and paediatric (5 studies) MDR-TB patients were included. Among the 32 adult studies, 19 were on susceptibility of Mycobacterium tuberculosis isolates to levofloxacin by MIC, 1 was on susceptibility of M. tuberculosis isolates to levofloxacin by MBC, 1 was on susceptibility of M. tuberculosis isolates to levofloxacin by mutant prevention concentration and 4 were on pharmacokinetics of levofloxacin, and 7 others were included. Likewise, out of five studies on children, two dealt with levofloxacin pharmacokinetic parameters, one reviewed CSF concentrations and two dealt with background information. In adult MDR-TB patients, standard dosing of once-daily 1000 mg levofloxacin in TB treatment did not consistently attain the target concentration (i.e. fAUC/MIC >100 and fAUC/MBC >100) in 80% of the patients with MIC and MBC of 1 mg/L, leaving them at risk of developing drug resistance. However, with an MIC of 0.5 mg/L, 100% of the patients achieved the target concentration. Similarly, paediatric patients failed consistently in achieving given pharmacokinetic/pharmacodynamic targets due to age-related differences, demanding a shift towards once daily dosing of 15-20 mg/kg. Therefore, we recommend therapeutic drug monitoring for patients with strains having MICs of ≥0.5 mg/L and suggest revising the cut-off value from 2 to 1 mg/L.
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Significant safety issues that have arisen with fluoroquinolones include phototoxicity, cardiotoxicity, tendinitis, CNS effects and drug interactions. Ciprofloxacin is well tolerated; the incidence of adverse events is low and serious adverse events are rare. Levofloxacin has a reduced CNS adverse event rate compared with ofloxacin. Sparfloxacin has significant phototoxicity and potential cardiac toxicity. Grepafloxacin has significantly increased adverse event rates, particularly gastrointestinal intolerance. Taste perversion and nausea are common. Trovafloxacin has an increased potential for CNS adverse reactions, notably dizziness. Post-marketing surveillance data indicate the possibility of serious hepatic reactions and pancreatitis. Interactions between fluoroquinolones and drugs metabolised by the hepatic cytochrome P450 system affect the clearance of theophylline and caffeine. Quinolone absorption is significantly reduced by co-administration of antacids. Hospitalised patients are likely to be receiving multiple-drug therapy, but drug interactions are avoidable. The interactions of specific fluoroquinolones should be checked prior to prescription.
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All levofloxacin-sensitive H. pylori isolates were sensitive to gemifloxacin. Eight strains (18.2%) resistant to levofloxacin could be still sensitive to gemifloxacin. Gemifloxacin achieved a 5-time lower in MIC levels against levofloxacin-resistant isolates. Nearly all levofloxacin-resistant isolates (97.7%, 43/44) had GyrA mutation at amino acid position 87 or 91. Double mutation sites may play dual roles in quinolone resistance, as N87K plus H57Y or D91N plus V77A mutations showed high-level resistance to both quinolones; whereas D91Y plus A97V or D91N plus A97V mutations showed low level levofloxacin resistance to become sensitive to gemifloxacin. In H. pylori isolates with single N87K, D91Y or D91N mutation, near 20% was gemifloxacin-sensitive and levofloxacin-resistant. The gemifloxacin-resistant rate of H. pylori was higher in patients with gastric ulcer than in those without (p <.05).
A mathematical model was fitted to time-kill data of moxifloxacin (0-128× MIC; MIC = 0.0625 mg/L) against E. coli MG1655 and levofloxacin (0-64× MIC; MIC = 0.25 mg/L) against S. aureus ATCC 29213 over 24 h. Based on the best-fit model parameters, the likelihood of resistance development associated with various dosing regimens was predicted. Subsequently, in vitro studies with a hollow-fibre infection model were selectively performed to validate the mathematical model predictions, using simulated human half-lives (moxifloxacin = 12 h; levofloxacin = 5-7 h).
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All inpatients who were dispensed oral levofloxacin from July 1, 1999, to June 30, 2001, were included. Coadministration was defined by documented administration of any DTCC within 2 hours of levofloxacin. Complete coadministration was defined as coadministration complicating every dose of a course of levofloxacin.
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Patients, in whom first treatment with omeprazole-clarithromycin-amoxicillin and a second trial with omeprazole-bismuth-tetracycline-metronidazole (or ranitidine bismuth citrate with these antibiotics) had failed, received 10 days of treatment with either rifabutin (150 mg b.d.) or levofloxacin (500 mg b.d.), plus amoxicillin (1 g b.d.) and omeprazole (20 mg b.d.). Cure rates were evaluated by the (13)C-urea breath test.
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A significant increase in the incidence of Legionnaires' disease in the United States has been documented over the last years. L. pneumophila has recently been found to be a leading cause of community-acquired pneumonia in hospitalized and ambulatory patients in Germany. Recent studies provide insight into the understanding of the pathogenesis of Legionnaires' disease and the relevance of the formation of biofilms. Clinical manifestations of Legionnaires' disease are not specific and current diagnostic scores are of limited use. Several recent studies offer useful information concerning Legionnaires' disease in immunosuppressed patients. A systematic review of English literature performed to assess test characteristics of Legionella urinary antigen has found that the pooled sensitivity of the test was 0.74 and specificity was 0.991. Improved clinical response has been observed for patients with Legionnaires' disease treated with highly active antimicrobial agents against Legionella.