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A multiple-dose, randomized, double-blind, controlled, cross-over trial was performed in 12 healthy male subjects in order to investigate the effect of a 7-day treatment with moxifloxacin (400 mg orally, once daily) versus clarithromycin (500 mg orally, twice daily) on the normal oropharyngeal microflora. Moxifloxacin caused significant reductions in levels of alpha-streptococci and Neisseria cocci during the treatment period, while the numbers of gram-negative anaerobic bacteria increased markedly during moxifloxacin administration. Clarithromycin administration caused a suppression of micrococci and corynebacteria, while no significant changes were recorded in the anaerobic microflora. No new colonizing moxifloxacin-resistant strains were isolated during the investigation period.
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Arguably, one of the most common and consequential laboratory tests performed in the world is Mycobacterium tuberculosis susceptibility testing. M. tuberculosis resistance is defined by growth of > or =1% of a bacillary inoculum on the critical concentration of an antibiotic. The critical concentration was chosen based on inhibition of > or =95% of wild-type isolates. The critical concentration of isoniazid is either 0.2 or 1.0 mg/liter, that of rifampin is 1.0 mg/liter, that of pyrazinamide is 100 mg/liter, that of ethambutol is 5.0 mg/liter, and that of fluoroquinolones is 1.0 mg/liter. However, the relevance of these concentrations to microbiologic and clinical outcomes is unclear. Critical concentrations were identified using the ability to achieve the antibiotic area under the concentration-time curve/MIC ratio associated with > or =90% of maximal kill (EC(90)) of M. tuberculosis in > or =90% of patients. Population pharmacokinetic parameters and their variability encountered in tuberculosis patients were utilized in Monte Carlo simulations to determine the probability that particular daily doses of the drugs would achieve or exceed the EC(90) in the epithelial lining fluid of 10,000 tuberculosis patients. Failure to achieve EC(90) in > or =90% of patients at a particular MIC was defined as drug resistance. The critical concentrations of moxifloxacin and ethambutol remained unchanged, but a critical concentration of 50 mg/liter was identified for pyrazinamide, 0.0312 mg/liter and 0.125 mg/liter were defined for low- and high-level isoniazid resistance, respectively, and 0.0625 mg/liter was defined for rifampin. Thus, current critical concentrations of first-line antituberculosis drugs are overoptimistic and should be set lower. With the proposed breakpoints, the rates of multidrug-resistant tuberculosis could become 4-fold higher than currently assumed.
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Enteric fever is a major cause of morbidity in several parts of the Indian subcontinent. The treatment for typhoid fever majorly includes the fluoroquinolone group of antibiotics. Excessive and indiscriminate use of these antibiotics has led to development of acquired resistance in the causative organism Salmonella Typhi. The resistance towards fluoroquinolones is associated with mutations in the target gene of DNA Gyrase. We have estimated the Minimum Inhibitory Concentration (MIC) of commonly used fluoroquinolone representatives from three generations, ciprofloxacin, ofloxacin, levofloxacin and moxifloxacin, for 100 clinical isolates of Salmonella Typhi from patients in the Indian subcontinent. The MICs have been found to be in the range of 0.032 to 8 μg/ml. The gene encoding DNA Gyrase was subsequently sequenced and point mutations were observed in DNA Gyrase in the quinolone resistance determining region comprising Ser83Phe/Tyr and Asp87Tyr/Gly. The binding ability of these four fluoroquinolones in the quinolone binding pocket of wild type as well as mutant DNA Gyrase was computationally analyzed by molecular docking to assess their differential binding behaviour. This study has revealed that mutations in DNA Gyrase alter the characteristics of the binding pocket resulting in the loss of crucial molecular interactions and consequently decrease the binding affinity of fluoroquinolones with the target protein. The present study assists in understanding the underlying molecular and structural mechanism for decreased fluoroquinolone susceptibility in clinical isolates as a consequence of mutations in DNA Gyrase.
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To the best of our knowledge, this is the first description of a P. acnes infection after LASIK and the first case of infection complicating a presbyopic LASIK procedure. Although infectious keratitis occurs rarely after refractive surgery, patients should be informed of the potential risk of visual loss caused by such infections.
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This paper describes a selective and ultra-sensitive analytical method for simultaneous determination of 11 fluoroquinolone (FQ) antibiotics in environmental and wastewater samples. The method employs offline solid-phase extraction (SPE) and reversed-phase high performance liquid chromatography with fluorescence detection (HPLC-FLD). A weak cation exchange SPE protocol was developed with a novel loading volume optimization algorithm and a methanol cleanup step to remove background organic matter. Various parameters were optimized to recover FQs from water/wastewater and analyte recovery was generally greater than 80%. Chromatographic separation of the 11 FQs was achieved on a 150 mm pentafluorophenyl column using a gradient elution scheme with methanol, acetonitrile, and 20mM phosphate buffer (pH=2.4). Excitation and emission wavelengths were individually optimized for each FQ using fluorescence spectroscopy; the excitation and emission wavelengths were 276-296 nm and 444-506 nm, respectively. Instrumental quantitation limits were 20-100 pg of mass injected. Of the 11 FQs investigated, seven (i.e., ciprofloxacin, difloxacin, enrofloxacin, fleroxacin, norfloxacin, moxifloxacin, and ofloxacin) were detected during a four-month sampling campaign of wastewater and wastewater-impacted surface water. Concentrations of FQs in raw wastewater, wastewater effluent, and wastewater-impacted surface water were 5-1292, 2-504, and 4-187ng/L, respectively.
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To evaluate the efficacy of the 14-d moxifloxacin-based triple therapy for the second-line eradication of Helicobacter pylori (H. pylori) infection.
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Seven antimicrobials were tested in vitro against 29 clinical isolates of Mycobacterium ulcerans. R207910 demonstrated the lowest MIC(50) and MIC(90), followed by moxifloxacin (MXF), streptomycin (STR), rifampin (RIF), amikacin (AMK), linezolid (LZD), and PA-824. All but PA-824 demonstrated an MIC(90) significantly less than the clinically achievable peak serum level. Administered as monotherapy to mice, RIF, STR, AMK, MXF, R207910, and LZD demonstrated some degree of bactericidal activity, whereas PA-824 failed to prevent mortality and to reduce the mean number of CFU in the footpads. Because 4 or 8 weeks of treatment by the combinations RIF-MXF, RIF-R207910, and RIF-LZD displayed bactericidal effects similar to those of RIF-STR and RIF-AMK, these three combinations might be considered as orally administered combined regimens for treatment of Buruli ulcer. Taking into account the cost, potential toxicity, and availability, the combination RIF-MXF appears more feasible for application in the field; additional experiments with mice are warranted to define further its activity against M. ulcerans. In addition, a pilot clinical trial is proposed to test the efficacy of RIF-MXF for treatment of Buruli ulcer.
Inhibition of the human ether-a-go-go-related gene (hERG) K(+) channel by drugs leads to QT prolongation on the electrocardiogram and can result in serious cardiac arrhythmia. For this reason, screening of drugs on hERG is mandatory during the drug development process. Patch clamp electrophysiology in a defined physiological saline solution (PSS) represents the standard method for assaying drug effects on the channel. To make the assay more translatable to clinical studies, we have conducted whole-cell patch clamping of hERG using pure human serum as the extracellular medium. Pure human serum had little effect on the hERG channel waveform or the current-voltage relationship when compared to PSS. hERG current recordings were highly stable in serum at room temperature, but prolonged recordings at the physiological temperature required prior heat inactivation of the serum. Compared to PSS, the IC50 values, conducted at room temperature, of the classic hERG blocking drugs cisapride, moxifloxacin, and terfenadine were shifted to the right by an extent predicted by their known plasma protein binding, but we did not detect any differences in IC50 s between male and female serum. Total plasma levels of these drugs associated with clinical QT prolongation corresponded to small (<15%) inhibition of hERG current in pure serum suggesting that minor inhibition of the channel leads to observable pharmacodynamic effects. Conducting whole-cell patch clamping of hERG in human serum has the potential to make the assay more translatable to clinical studies and improve its predictive value for safety testing. Copyright © 2016 John Wiley & Sons, Ltd.
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We found no significant difference in re-epithelialization rates following topical application of gatifloxacin 0.3% and moxifloxacin 0.5%. Both antibiotic solutions delayed healing compared to BSS. Our analysis suggests that there was no apparent added epithelial toxicity due to the presence of BAK in the gatifloxacin preparation.
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Eradication rates in first-line Helicobacter pylori therapy have been declining over the last decades, mainly due to increasing resistance against the recommended antibiotics clarithromycin and metronidazole. Thus, there is a need to evaluate novel regimens and substances to offer effective alternative treatment strategies. New generation quinolones, like levofloxacin and moxifloxacin, exhibit a broad-spectrum activity against various Gram-positive and Gram-negative strains and are mostly well tolerated. Based on a large number of studies, quinolones have been introduced in second-line and rescue treatment and are recommended for these indications in current guidelines. Various studies have investigated alternative strategies for first-line treatment including quinolone-based regimens. In the context of increasing resistance rates of Helicobacter pylori against quinolones some risks and benefits have to be considered when using quinolones as a first-line strategy. Besides numerous studies investigating levofloxacin and moxifloxacin there are some promising results for the new substance sitafloxacin, which might overcome primary resistance of Helicobacter pylori against conventional quinolones.
The highest killing of M. abscessus was observed between 24 and 72 h; amikacin had the highest Emax (0.0427 h(-1)), followed by clarithromycin (0.0231 h(-1)) and cefoxitin (0.0142 h(-1)). For M. fortuitum, between 3 and 24 h, amikacin also showed the highest Emax (0.1933 h(-1)). There were no significant differences between the Hill's slopes determined for all the antibiotics tested against M. abscessus or M. fortuitum (P = 0.2213 and P = 0.2696, respectively).
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The AC lacks concordance with vitreous findings in cases of endophthalmitis. Use of broad-spectrum antibiotics to sterilize the ocular surface and provide therapeutic levels in the AC may not prevent endophthalmitis. In this study, the finding of a sterile AC did not rule out vitreous infection. These results may have implications for the routine use of broad-spectrum antibiotics as a means of vitreous protection and endophthalmitis prophylaxis.
Sixty-eight patients undergoing routine phacoemulsification with intraocular lens implantation received either moxifloxacin 0.5% alone or moxifloxacin 0.5% combined with dexamethasone. For both groups, 1 drop of the test solution was instilled 4 times daily 1 day preoperatively and 1 drop 1 h preoperatively. An aqueous humor sample obtained immediately before paracentesis was submitted to high-performance liquid chromatography-tandem mass spectrometry to determine the moxifloxacin concentration.
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Topical prophylaxis with MFLX/DEX eye drops was well tolerated and is therapeutically equivalent to conventional dosing with moxifloxacin and dexamethasone from individual bottles.
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The positive results obtained with the IQ-CSRC study require additional confirmation with threshold QTc-positive and negative drugs and established QTc prolongers producing both increases and decreases in heart rate. In the future, similar studies should also adopt and validate innovative proarrhythmic metrics, in addition to, or instead of, the traditional proarrhythmic surrogate of QTc, to assess the proarrhythmic safety of candidate drugs.
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Clinical evaluation of adverse events (AEs) during prolonged moxifloxacin treatment.
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Four hundred and ninety-five Gram-negative anaerobic clinical isolates (296 Bacteroides fragilis group, 58 non-fragilis Bacteroides spp. and 141 Prevotella spp.) were prospectively recovered in six Greek hospitals. Moxifloxacin MICs were determined in comparison with those of penicillin, piperacillin/tazobactam, cefoxitin, imipenem, metronidazole and clindamycin.
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Prophylactic topical moxifloxacin 0.5% treatment starting 1 day before ocular surgery resulted in a significant increase in fluoroquinolone-resistant bacteria, while a 3-day antibiotic regimen did not select for resistant organisms.
Although A. xylosoxidans ocular infections are rare, one should retain a high index of clinical suspicion in patients who present with slowly progressive disease characterized by a localized infiltration and show Gram-negative bacilli on smear examination.
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A combination of E tests and disk diffusion methods was used to determine in vitro susceptibility and cross-resistance for 111 coagulase-negative staphylococci isolates recovered during a 15-year period (January 1, 1990, to December 31, 2004) against 5 fluoroquinolones.
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The aim of this study was to compare the performance of several recently developed assays for the detection of multi- and extensively drug-resistant tuberculosis (M/XDR-TB) in a large, multinational field trial.
In periodontal pockets with PD of ≥5.4 mm, a single subgingival administration of a 0.4% moxifloxacin gel as an adjunct to SRP may result in additional PD reduction compared to SRP alone. In addition, the investigated moxifloxacin gels seem to be safe.
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Besifloxacin acts as an anti-inflammatory agent in corneal epithelial cells in vitro, by inhibiting the NFkappaB and MAPK pathways. Besifloxacin also exhibits anti-inflammatory efficacy in vivo. The anti-inflammatory attribute may enhance its efficacy in the treatment of ocular infections with an inflammatory component and warrants further investigation.
In vitro cell cultures are useful for evaluating cell response to potentially toxic insults, although cell cultures may lack tissue components that may prevent or ameliorate damage in vivo. In this assay, fluoroquinolones displayed the potential to be cytotoxic to human corneal keratocytes and endothelial cells, depending on drug concentration and duration of exposure. The potential for cytotoxicity may differ among fluoroquinolones.
The efficacy of moxifloxacin in the treatment of an implant-associated infection by Staphylococcus aureus was compared with vancomycin in an animal study. The femoral medullary cavity of 36 Wistar rats was contaminated with S. aureus (ATCC 29213) and a metal device was implanted. After treatment for 14 days with moxifloxacin (2 x 10 mg/kg/day) or vancomycin (2 x 15 mg/kg/day), the bacterial counts (colony-forming units) in the periprosthetic bone, the soft tissue and the implant-associated biofilm were measured. Compared with the control group, moxifloxacin achieved a highly significant decrease in the microbial counts in the bone and soft tissue and in the biofilm (P<0.001). Moreover, the efficacy of moxifloxacin was significantly greater than that of vancomycin (P<0.01). Vancomycin did not reduce the microbial count significantly compared with the control group (P>0.05). The results justify further investigations of the treatment of implant-associated infections due to S. aureus with moxifloxacin.
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The prevalence of drug resistance among clinical, nonduplicate Mycobacterium tuberculosis isolates was analyzed. Testing of susceptibility to antituberculosis agents, including isoniazid, rifampicin, ethambutol, streptomycin, rifabutin, ofloxacin, ethinamide, and para-aminosalicylic acid, was performed using the proportional method. Minimum inhibitory concentrations of amikacin, capreomycin, isepamycin, linezolid, cycloserine, ciprofloxacin, levofloxacin, moxifloxacin, and gemifloxacin were determined for 40 available multidrug-resistant M. tuberculosis isolates.
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The developed heart rate model fitted well, both to the training data set (RMSE = 128 ms and MAPE = 12.3%) and the validation data set (RMSE = 165 ms and MAPE = 17.1%). Simulations performed at the population level proved that the combination of the IVIVE platform and the population variability description allows for the precise prediction of the circadian variation of drugs proarrhythmic effect.
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The reaction was nucleophilic substitution using hydrolysable linkers like Chloroacetyl chloride (CAC) & Succinyl chloride (SCL). The drugs were covalently linked as INH-CAC-MOXI (DDC-1) and INH-SCL-MOXI (DDC-2). The DDC-1 & DDC-2 were subjected to hydrolysability tests at different pH solutions. The modified drugs were formulated into Poly (D, L-Lactic-co-Glycolide) nanoparticles using single emulsion technique. Design Expert® (version 8.0.1) software was used for designing, and evaluating the prepared formulation by employing response surface, optimal design of experiment technique.
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This thorough QT/QTc study was a negative study in accordance with the ICH E14 guideline, meaning that nalmefene has no clinically relevant effect on the QTc interval and T-wave morphology. The study predicts no concern over proarrhythmia or need for intensive QTc monitoring with the use of nalmefene in clinical practice.
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In pelvic inflammatory disease, fluoroquinolones are not first-line drugs and moxifloxacin is the worst of these drugs.
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This thorough QT study, which was performed in accordance with ICH E14 guidelines, shows that rivaroxaban does not prolong the QTc interval. Therefore, the potential of rivaroxaban for the prevention and treatment of thromboembolic disorders, including chronic cardiovascular disorders, can be investigated in appropriate clinical studies without the need for intensive monitoring of the QTc interval.
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We identified all hospital-acquired isolates from 14 hospitals in the Northern California Kaiser Permanente health care delivery system between 1998 and 2003 and determined their susceptibility to ciprofloxacin. For each facility, we determined the number of days of fluoroquinolone use per 1000 patient-days, by calendar quarter. We used a logistic regression model to analyze the data, with susceptibility status as the outcome variable. Hospital-level rates of use of the 3 fluoroquinolones were the predictors of interest; we adjusted for year, for use of nonquinolone antimicrobials, and for patient variables, including the number of days spent in the hospital in the prior year and fluoroquinolone use in the prior year. The model tested whether isolates from those facilities with higher rates of use of antimicrobials were more likely to be nonsusceptible to ciprofloxacin.
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A total of 683 culture-positive hand infections were identified. Overall, methicillin-resistant Staphylococcus aureus grew on culture in 49% of cases; the annual incidence peaked at 65% in 2007. Over the study period, methicillin-resistant Staphylococcus aureus was universally resistant to penicillin, oxacillin, and ampicillin. Clindamycin resistance significantly increased, approaching 20% by 2012 (p = 0.02). Levofloxacin resistance linearly increased from 12% to 50% (p < 0.01). Resistance to trimethoprim-sulfamethoxazole, tetracycline, gentamicin, and moxifloxacin was only sporadically observed. Resistance to vancomycin, daptomycin, linezolid, and rifampin was not observed.
This case report describes a case of Legionnaires' disease for whom the source of infection was the campervan in which the patient had travelled for 3 months. This case shows that Legionnaires' disease can be acquired by exposure to a relatively new (not previously reported) source that is commonly used as (holiday)transportation vehicle.