Chinfloxacin hydrochloride is a novel tricyclic fluorinated quinolone in development for treatment of conventional and biothreat infections. This first-in-human randomized study in Chinese healthy subjects was divided into 5 parts. Part A was a single ascending dose study to assess safety and tolerability of chinfloxacin. The single dose pharmacokinetic study, food effect study and a multiple dose pharmacokinetics study was conducted in Part B, Part C and Part D, respectively. Part E was a randomized, placebo- and positive-controlled single-dose, crossover study to evaluate the effect of chinfloxacin on thorough electrocardiographic QT/QTc interval. The results suggest that single and multiple oral administration of chinfloxacin were well tolerated. The observed adverse events (AEs) were dizziness, nausea, weakness, photosensitive dermatitis and increased frequency of defecation. All AEs were mild and were resolved spontaneously without any treatment. The time to Cmax (Tmax) was about 2 h and T1/2 was 14-16 h. Food slightly affected the drug's rate and extent of absorption, increasing the Tmax from 1.60 to 2.59 h and reducing the Cmax by 13.6% and AUC by 8.95%, respectively. Chinfloxacin 400 mg had no effect on prolongation of QT/QTc intervals. Although chinfloxacin 600 mg caused mild effect on prolongation of QT/QTc interval, the effect was less pronounced than that of the positive control, moxifloxacin 400 mg. The pharmacokinetics and safety profiles of chinfloxacin in healthy Chinese volunteers support its once-daily dosing in future clinical investigations. (This study has been registered at ChiCTR.org.cn. Identifier of Part A to Part D: ChiCTR-TRC-10001619; Identifier of the Part E: ChiCTR1800015906.).

There is an ever-increasing demand for the therapeutic drug monitoring of antibiotics in many clinical facilities, particularly with regard to the implementation of hospital antibiotic stewardship programs. In the current work, we present a multiplex high-performance liquid chromatography-tandem mass spectrometry (HPCL-MS/MS) protocol for the quantification of cefepime, meropenem, ciprofloxacin, moxifloxacin, linezolid, and piperacillin, commonly used antibiotics in intensive care units. The method was previously comprehensively validated according to the guideline of the European Medicines Agency. After a rapid sample cleanup, the analytes are separated on a C8 reverse-phase HPLC column within 4 minutes and quantified with the corresponding stable isotope-labeled internal standards in electrospray ionization (ESI+) mass spectrometry in multiple reaction time monitoring (MRM). The presented method uses a simple instrumentation setting with uniform chromatographic conditions, allowing for the daily and robust antibiotic therapeutic drug monitoring in clinical laboratories. The calibration curve spans the pharmacokinetic concentration range, thereby including antibiotic amounts close to the minimal inhibitory concentration (MIC) of susceptible bacteria and peak concentrations (Cmax) that are obtained with bolus administration regimens. Without the necessity of the serum dilution before the sample cleanup, the area under the curve for an administered antibiotic can be obtained through multiple measurements.

Background: Extensive evidence-based literature supports the use of intracameral (IC) moxifloxacin for the prevention of postoperative endophthalmitis after cataract surgery. The Aurora Pharmacy Packaging Center (APPC) has developed a process for centrally preparing IC moxifloxacin. Purpose: The aim of this study was to evaluate the centralized preparation of IC moxifloxacin production for quality assurance and to quantify a potential reduction in costs. Methods: The APPC's compounding procedure of IC moxifloxacin was evaluated using United States Pharmacopeia (USP) Convention 797 standard and compared with practices described in evidence-based literature. Patients who received IC moxifloxacin intraoperatively from one of 3 ophthalmologists during cataract surgery performed between February 15, 2016, and August 15, 2016, were identified using electronic health records. Cost savings were calculated by reviewing costs associated with drug supplies used by the APPC. Results: The APPC process for the centralized preparation of IC moxifloxacin was deemed compliant with USP 797's sterile compounding standards. USP 797 validation criteria included proper sterile technique, equipment, room sterility and pressure, beyond use dating, and storage. Implementation of the centralized production of moxifloxacin reduced the direct product cost per surgery from $140 to $20 (a cost savings of $120 per surgery). There were 459 cataract surgeries analyzed during the study period, resulting in a savings of $55 080 over 6 months. Conclusion: The APPC's centralized compounding procedure was found to be compliant with pharmacy compounding standards and to yield significant cost savings.

The concern about the possibility of food can be a vehicle for the transmission of Clostridium difficile to humans has been raised recently due to the similarities among the strains isolated from patients, foods and food animals. In this study, therefore, the prevalence of C. difficile was investigated in beef and chicken meat products collected from 57 different butcher shops, markets and fast food restaurants in Sakarya province of Turkey. Two out of 101 samples (1.98%) was positive for C. difficile indicating a very low prevalence. The pathogen was isolated from an uncooked meatball sample and a cooked meat döner sample, whereas not detected in chicken meat samples. The meatball isolate was resistant to vancomycin and tetracycline, while the cooked meat döner isolate was resistant to vancomycin and metronidazole. Both isolates were sensitive to moxifloxacin and clindamycin. Toxins A and B were not detected. This study reveals the presence of C. difficile in further processed beef products in Turkey.

A 75-year old woman, with a history of use of immunosuppressive treatment for rheumatoid arthritis and non-Hodgkin lymphoma, was referred to our reference center for treatment of tenosynovitis caused by Mycobacterium malmoense, which had disseminated due to immunosuppressive therapy. This rare diagnosis was made after years of treatment for supposed rheumatoid arthritis. The patient presented with relapsing tenosynovitis with wounds on her right middle finger and wounds on her left lower leg, despite three months of adequate therapy (rifampicin-ethambutol-clarithromycin). Therapy was intensified with amikacin, clofazimine, moxifloxacin and interferon gamma due to lack of response. Amputation of the right middle finger was necessary due to advanced disease. Treatment was further complicated by a paradoxical reaction, requiring prednisone treatment, ultimately led to cure.

Moxifloxacin is widely used for the treatment of a number of infectious diseases because of its favorable pharmacological profile and high clinical success rate. However, it is often criticized for its higher risk of QTc interval prolongation (QTIP) and torsades de pointes (TdP). Areas covered: A review of published literature on moxifloxacin-related QTIP and TdP. Readers will be provided with a comprehensive overview of the prevalence, cellular mechanism, risk factors, and magnitude of QTIP of moxifloxacin. Expert commentary: In healthy subjects, moxifloxacin prolongs the QTc interval by 11.5-19.5 ms, it binds at the Tyr652 residue in the S6 pore domain of the human ether a-go-go gene related potassium channel. Considerable QTIP (30-60 ms) have also been reported in some patients, for instance the incidence of QTIP (30-60 ms) in elderly pneumonia patients was 15.5%. Moxifloxacin-induced QTIP may be of little clinical importance in healthy individuals. However, marked QTIP (>60 ms) and TdP have been reported in high-risk patients (patients who have multiple QT prolonging risk factors). Patients must be thoroughly assessed prior to the use of moxifloxacin and high-risk patients must be identified using risk assessment tools to ensure safe use of moxifloxacin and to safeguard patients' health.