Development and characterization of lyophilized cefpodoxime proxetil-Pluronic® F127/polyvinylpyrrolidone K30 solid dispersions with improved dissolution and enhanced antibacterial activity.

The aim of this study was the development of hard-cellulose capsules containing cefpodoxime proxetil (CEF) (BCS Class II) loaded novel Pluronic® F127 (P127)/Polyvinylpyrrolidone K30 (PVP) solid dispersions (SDs) using ultrasonic probe induced solvent-lyophilization method for effective antibacterial treatment by means of improved saturated aqueous solubility, dissolution rate, reduced particle size, and wettability. SDs were evaluated for physical and solid-state analyses. The solubility of pure CEF was calculated as 0.269 ± 0.005 mg/mL, SDs formulated with P127/PVP exhibited increased solubility from 3.5- to 8-fold. Molecular distribution of CEF in SDs and formation of CEF loaded amorphous polymeric network were confirmed with morphological study, thermal analysis, Fourier-transform infrared spectroscopy (FT-IR), and 1H-NMR studies. Staphylococcus aureus (ATCC 29213), Escherichia coli (ATCC 25922), and Klebsiella pneumoniae (ATCC 700603) were used to investigate the antibacterial effectiveness of the SDs. The minimum inhibitory concentration (MIC) values of the P127/PVP SDs were found 2-8 times lower than the pure CEF. All SDs from hard-cellulose capsules exhibited significantly faster release than unprocessed CEF. The profiles of SDs and reference were detected to be dissimilar according to difference (f1) and similarity factor (f2). Hard-cellulose capsules containing CEF loaded P127/PVP SDs appear to be feasible alternative to commercially available CEF tablets for effective antibacterial therapy at lowest dose.

Effects of antibiotics on prevention of infection, white blood cell counts, and C-reactive protein levels at different times in the perioperative period of cesarean section
.

OBJECTIVE: To evaluate the effects of antibiotics on prevention of infection, white blood cell (WBC) counts and C-reactive protein (CRP) levels at different times in the perioperative period of cesarean section. MATERIALS AND METHODS: A total of 486 women undergoing cesarean section were randomly divided into groups A, B, and C (n = 162). Group A was intravenously infused with 250 mL of 0.9% normal saline containing 2 g cefuroxime sodium 30 minutes before surgery within 30 - 45 minutes. Group B was given cefuroxime 30 minutes before surgery and 3 days after surgery, respectively. Group C was given cefuroxime only after returning to ward, once daily for 3 consecutive days. The surgical time, intraoperative blood loss, postoperative hospital-stay length, hospitalization expenditure, maximum body temperature, WBC count and CRP level 3 days after surgery, grade A healing rate of incision at discharge, and incidence of infection were compared. RESULTS: Group A had the shortest postoperative hospital-stay length and lowest hospitalization expenditure (p < 0.05). The maximum body temperature, WBC count and CRP level of group A 3 days after surgery were lowest (p < 0.05). The three groups had similar grade A healing rates of incision (p > 0.05). The postoperative infection rates of groups A and B were similar (p > 0.05), both being significantly lower than that of group C (p < 0.05). CONCLUSION: Single prophylactic use of antibiotics 30 minutes before surgery effectively prevented infection after cesarean section and shortened the hospital-stay length. This method is worthy of clinical promotion due to short duration of antibiotic use and low hospitalization expenditure.

Extrapolation of Drug Clearance in Children ≤ 2 Years of Age from Empirical Models Using Data from Children (> 2 Years) and Adults.

BACKGROUND: The application of modeling and simulation approaches in clinical pharmacology studies has gained momentum over the last 20 years. OBJECTIVES: The objective of this study was to develop six empirical models from clearance data obtained from children aged > 2 years and adults to evaluate the suitability of the models to predict drug clearance in children aged ≤ 2 years (preterm, term, and infants). METHODS: Ten drugs were included in this study and administered intravenously: alfentanil, amikacin, busulfan, cefetamet, meperidine, oxycodone, propofol, sufentanil, theophylline, and tobramycin. These drugs were selected according to the availability of individual subjects' weight, age, and clearance data (concentration-time data for these drugs were not available to the author). The chosen drugs are eliminated by extensive metabolism by either the renal route or both the renal and hepatic routes. The six empirical models were (1) age and body weight-dependent sigmoidal maximum possible effect (Emax) maturation model, (2) body weight-dependent sigmoidal Emax model, (3) uridine 5'-diphospho [body weight-dependent allometric exponent model (BDE)], (4) age-dependent allometric exponent model (ADE), (5) a semi-physiological model, and (6) an allometric model developed from children aged > 2 years to adults. The model-predicted clearance values were compared with observed clearance values in an individual child. In this analysis, a prediction error of ≤ 50% for mean or individual clearance values was considered acceptable. RESULTS: Across all age groups and the ten drugs, data for 282 children were compared between observed and model-predicted clearance values. The validation data consisted of 33 observations (sum of different age groups for ten drugs). Only three of the six models (body weight-dependent sigmoidal Emax model, ADE, and semi-physiological model) provided reasonably accurate predictions of clearance (> 80% observation with ≤ 50% prediction error) in children aged ≤ 2 years. In most instances, individual predicted clearance values were erratic (as indicated by % error) and were not in agreement with the observed clearance values. CONCLUSIONS: The study indicated that simple empirical models can provide more accurate results than complex empirical models.

Taste-masking and colloidal-stable cubosomes loaded with Cefpodoxime proxetil for pediatric oral delivery.

Drug administration failure has been often witnessed in pediatric due to children's resistance to take medicines with bitter taste. Taste-masking is the key requirement among the scanty drugs available for children. Solid taste-masking systems, such as tablets and capsules, are difficult to swallow for children. Therefore, a liquid taste-masking system based on lyotropic liquid crystalline nanoparticles (LLCNs) was developed in this study. Cefpodoxime proxetil (CFP), a typically bitter drug used as antibiotic in pediatric, was selected as the model drug, and the encapsulation of CFP into the LLCNs was envisaged to improve their taste. Pluronic F127 was added to improve the colloidal stability of CFP-LLCNs. The optimized CFP-LLCNs showed the particle size of 187.29 ± 4.12 nm and the encapsulation efficiency of 85.80%. The mesophase analysis by polarized light microscopy and small angle X-ray scattering confirmed the cubic phase of CFP-LLCNs. It showed a sustained-release profile well fitted to Higuchi model, indicating that diffusion and erosion were both responsible for the CFP release. The taste-masking ability of CFP-LLCNs was confirmed by electronic tongue, compared to CFP and commercial product. The colloidal stability was verified after 3 months storage in room condition (25 ± 2 °C, 70 ± 2%RH). To sum up, the taste-masking and colloidal-stable CFP-LLCNs showed great potential for pediatric oral delivery.

Evaluation of prophylactic antibiotic regimens on recurrence and mortality in spontaneous bacterial peritonitis.

INTRODUCTION AND OBJECTIVES: Limited data describe current SBP epidemiology and specific secondary SBP prophylactic regimens, leading to variable prescribing practices. This work aims to compare 90-day and one-year SBP recurrence and mortality based on secondary SBP antibiotic prophylaxis regimens. MATERIALS AND METHODS: We performed a retrospective cohort of patients >18 years with an SBP diagnosis from 2010 to 2015 at two academic institutions. Eligible patients had ascitic PMN counts ≥250cells/mm3 or a positive ascitic culture. Patients were compared based on secondary SBP prophylaxis regimens (i.e., daily, intermittent, or no prophylaxis). RESULTS: Of 791 patients with ascitic fluid samples, 86 patients were included. Antibiotic prophylaxis included daily (n=34), intermittent (n=36), or no prophylaxis (n=16). Nearly half of SBP episodes had a positive ascitic fluid culture; 50% were gram-negative pathogens, and 50% were gram-positive pathogens. Daily and intermittent regimens had similar rates of recurrence at 90-days (19.4% vs. 14.7%, p=0.60) and one-year (33.3% vs. 26.5%, p=0.53). Similarly, mortality did not differ among daily and intermittent regimens at 90-days (32.4% vs. 30.6%, p=0.87) or one-year (67.6% vs. 63.9%, p=0.74). When comparing any prophylaxis vs. no prophylaxis, there were no differences in 90-day or one-year recurrence or mortality. CONCLUSIONS: In patients with a history of SBP, our data indicate similar outcomes with daily, intermittent, or no secondary antibiotic prophylaxis. With available data, including ours, demonstrating a changing epidemiology for SBP pathogens, further data is required to determine if traditional approaches to secondary SBP prophylaxis remain appropriate.

Cefpodoxime proxetil as a therapeutic option in switching therapy for infective endocarditis in children: case reports and literature review.

Infective endocarditis (IE) is uncommon in children, affecting predominantly subjects with congenital heart disease (CHD) and patients with indwelling central lines. The principles of antibiotic treatment in paediatric population are similar to those in adults. Prolonged intravenous administration of bactericidal rather than bacteriostatic agents is preferred. Outpatient intravenous therapy after initial treatment in the hospital may be considered only in selected patients. Partial oral treatment has been described in cases of left-sided, uncomplicated IE caused by common pathogens in adult patients. There are no guidelines or trials in paediatric population regarding switching therapy from intravenous to oral route. We present two cases of IE in children caused by uncommon pathogenic bacteria (Abiotrophia defectiva and Haemophilus parainfluenzae) successfully treated with oral third-generation cephalosporin - cefpodoxime proxetil after initial intravenous therapy. This paper provides observations on different therapeutic approach for IE in children as well as another potential use of cefpodoxime proxetil.

Levofloxacin versus Cefpodoxime for Antibacterial Prophylaxis in Allogeneic Stem Cell Transplantation.

National guidelines recommend antimicrobial prophylaxis for allogeneic stem cell transplant patients during the pre-engraftment period because of increased infection risk during neutropenia. Fluoroquinolones have demonstrated lower rates of bacteremias and incidence of neutropenic fever, but there is limited evidence in the use of alternative antibacterials such as cefpodoxime. The primary objective of this study is to compare the rates of antibiotic prophylaxis failure between levofloxacin and cefpodoxime in allogeneic stem cell transplant recipients. Secondary objectives include comparing and characterizing number and type of infections, mortality at day 100 post-transplant, and hospitalizations for infectious causes in the first 100 days of transplant. This is a single-center, retrospective chart review of adult patients who received an allogeneic stem cell transplant from matched related and matched unrelated donors and antibacterial prophylaxis with levofloxacin or cefpodoxime from January 1, 2011, to October 1, 2014. A total of 142 patients were evaluated (71 levofloxacin, 71 cefpodoxime). Both levofloxacin and cefpodoxime groups had similar rates of neutropenic fever and antibiotic prophylaxis failure (58% versus 58%, P = NS). There were similar incidences of Clostridioides difficile and Multi-drug resistant (MDR) infections among both levofloxacin and cefpodoxime groups. Rates of infections, hospitalizations, and mortality in the first 100 days were similar among both groups. Cefpodoxime can be used as an alternative to levofloxacin for antibiotic prophylaxis in allogeneic stem cell transplant patients.

Disposition of ceftizoxime in Staphylococcal mastitis in Indian crossbred cows.

Disposition of ceftizoxime was studied in Indian crossbred cows following a single IV dosing in field conditions. Six healthy lactating and six mastitic crossbred cows were assigned to two groups (Group 1 and Group 2). A single IV administration of ceftizoxime at the dose rate of 20mg/kg was administered to cows in both groups. Peak concentrations were recorded at 5min, decreasing sharply until 1h with plasma concentrations of 46.38±0.30µg/mL; concentrations were below detection limits at 24h. Ceftizoxime achieved peak concentrations at 96h and persisted up to 120h at a concentration of 36.71±0.96µg/mL in the milk of mastitic Indian crossbred cows. Staphylococcal colony count in acute mastitis was 52.33±4.98×105 colony forming units/mL milk and no growth was detected at 96h post-dosing, indicating that ceftizoxime following single IV administration at 20mg/kg may be effective to treat acute staphylococcal mastitis.

Roultella ornithinolytica infection in infancy: a case of febrile urinary tract infection.

Raoultella ornithinolytica is a Gram-negative, non-motile, encapsulated, aerobic bacillus belonging to the Enterobacteriaceae family. R. ornithinolytica is a not very common, but emergent causal agent of human infection, and its expression of beta-lactamase provides resistance to commonly used antibiotics. The pathogenetic potential of R. ornithinolytica isolates in human disease has become increasingly important. Several cases of hospital-acquired infection, mostly associated with invasive procedures, or in patients with co-morbidity caused by R. ornithinolytica, have been previously reported in the adult population. In pediatric population, two cases in immunocompromised children, one case in an infant with visceral heterotaxy and one case of catheter-related bacteraemia are described. Here, we present the first case of febrile urinary tract infection due to R. ornithinolytica in an 8-month-old infant, recovered from a previous febrile UTI caused by E. coli and without co-morbidity. The empiric therapy with ceftriaxone, followed by cefpodoxime proxetil, resolved symptoms: the clinical condition of the infant improved rapidly and the treatment eradicated urine from the R. ornithinolytica infection. Since other pathogens rather than R. ornithinolytica are usually identified in children with urinary tract infections, including Escherichia coli, Proteus, Klebsiella and Pseudomonas, the identification of this microorganism in our patient's urine was also unexpected.

Validated HPLC method for the pharmacokinetic study of oral extended-release cefpodoxime proxetil chitosan-alginate beads in rabbits.

The aim of this study is to develop a simple and applicable HPLC method for the detection of cefpodoxime acid (CFA) in rabbit plasma after oral administration of cefpodoxime proxetil (CFP) loaded chitosan-alginate (CH-ALG) beads formulation. CFP is a prodrug that is deesterified in vivo to its active metabolite CFA to exhibit antibiotic activity. Chromatographic separation of CFA and internal standard (IS) was achieved by a RP18(C18), Phenomenax®100, (250×4.6mm) with the mobile phase consisting of (0.02mol/l (20mM) ammonium acetate solution and acetonitrile (92:8, v/v, pH=4.6) at a flow rate of 1.0ml/min. The method was validated according to the requirements of US-FDA guidelines for bioanalytical method validation. The linear regression analysis for the calibration plots showed good linear relationship (R2=0.9905) in the working concentration range of 0.5-50µg/ml. The limits of detection and quantification (S/N=3) were 0.069 and 0.136µg/ml. Plasma CFA levels were successfully determined in rabbit with satisfactory precision and accuracy. The analyte was found to be stable after a number of stability studies. The proposed HPLC method was successfully applied to pharmacokinetic study in rabbits for CFP loaded CH-ALG beads and marketed immediate release (IR) tablets. All pharmacokinetic parameters were assessed.

Using Monte Carlo simulation to determine optimal dosing regimen for cefetamet sodium for injection.

The objective of the study was to use Monte Carlo simulation to determine the optimal treatment dosing regimen of the cefetamet sodium for injection by analysing the pharmacokinetics (PK) parameters in healthy Chinese volunteers, and antibacterial activity in vitro was also examined. A three-cross Latin square single-dose PK study was designed. Twelve healthy volunteers were randomized to receive 500, 1000, and 2000 mg of cefetamet sodium for IV infusion over 30 minutes in three periods sequentially; and the washout time in between periods was 3 days. The drug concentrations in plasma were analysed by high-performance liquid chromatography, and the PK parameters were calculated using DAS2.0 PK software. The peak concentrations (Cmax) at 0.5 hours were 37.78±7.29, 76.18±12.81, and 149.32±29.94 mg/l, the areas under concentration-time curve (AUC0-t) were 69.75±14.44, 139.06±22.62, and 278.54±53.12 mg h/l, and the elimination half-life (t1/2) were 1.69±0.19, 1.69±0.27, and 1.81±0.23 hours for 500, 1000, and 2000 mg of cefetamet sodium for injection, respectively. The disposition of cefetamet was appear to fit a two-compartment model with linear kinetics. Antibacterial activity in vitro showed that most Gram-negative bacteria, including non-extended-spectrum beta-lactamases (ESBL)-producing Enterobacter, Haemophilus influenzae, Moraxella catarrhalis, and Neisseria gonorrhoeae, were sensitive to cefetamet. The result of Monte Carlo simulation showed that the probability of target attainment for bactericidal response (%fT>MIC≧50%) for susceptible bacteria was reached at all three dosing regimens of 500 mg, q6h, 1000 and 2000 mg, q8h and q6h. Considering the efficacy, safety, and pharmacoeconomy comprehensively, we recommended the dosing regimen of 500 mg, q6h for further clinical treatment based on the principle of minimum daily dosage.

Successful Treatment of Refractory Majocchi's Granuloma with Voriconazole and Review of Published Literature.

Majocchi's granuloma (MG) is a rare deep skin dermatophyte infection that can occur either in immunocompetent or in immunocompromised individuals. Oral itraconazole or terbinafine is considered to be the first choice of treatment. We report an immunocompetent man with deep nodular form of MG, the form which is generally found in immunosuppressed individuals. Previous treatment with either oral itraconazole or terbinafine yielded no apparent improvement. After a series of examination, the man was diagnosed as having Trichophyton rubrum-induced MG mixed with bacterial infection as evidenced by growth of Klebsiella pneumoniae in tissue bacterial culture. The patient was treated with a combination of cefoselis and levofloxacin for bacterial clearance followed by voriconazole treatment. After approximately 4 months of voriconazole treatment, the lesions completely resolved. Alternative medicine (voriconazole) can be considered in case of refractory infections during MG treatment.

Efficacy of (99m)Tc-Labeled Ceftizoxime in the Diagnosis of Subclinical Infections Associated with Titanium Implants in Rats.

BACKGROUND: Metal implants are used frequently in orthopedic procedures and the occurrence of subclinical low-virulence infection is difficult to diagnose. The objective of this study was to examine the hypothesis that peri-prosthetic subclinical infections may be diagnosed effectively in a murine model system using scintigraphic imaging with (99m)Tc-labeled ceftizoxime. METHODS: A sample population of 3-mo old Wistar rats (mean weight 327 g) was divided randomly into a control group (n=6), which received sterile implants, and an experimental group (n=6), which received implants contaminated with Staphylococcus aureus strain ATCC6538-P. Animals were anesthetized and femoral titanium implants were fixed beneath muscle tissue in left hind limbs. Three weeks after surgery, animals were injected with (99m)Tc-ceftizoxime solution (62.9 MBq) and scintigraphic images were obtained at 3.5 and 6.5 h after tracer injection. RESULTS: According to the scintigraphic images, the radiopharmaceutical showed affinity for the operated thigh areas of experimental animals but not for those of the control group. There was no difference between the control and experimental groups regarding the amount of radioactivity in the regions of interest measured at 3.5 h after injection of radiolabeled antibiotic, but the between-group difference determined at 6.5 h after treatment was statistically significant (p=0.026). Moreover, the level of radioactivity recorded in resected thigh tissues derived from experimental animals was greater than that of the control group (p=0.035). CONCLUSION: (99m)Tc-ceftizoxime scintigraphy can localize preferentially periprosthetic-infected areas adjacent to metal implants in a murine model. Furthermore, the radiolabeled antibiotic appears to be capable of detecting alterations in the micro-environment close to the implant and of reaching the bacteria attached to the implant surface.

Endocarditis tricuspid sub-aigue of post abortion: report of a case.

Tricuspid infective endocarditis is rare and represents five to 10% of all cases of infective endocarditis. It occurs predominantly in intravenous drug users, and patients with central venous catheters or intracardiac probes. We report on the case of subacute tricuspid infective endocarditis in a girl of 17 years. She had no particular cardiovascular history. She was admitted for a persistent fever with cachexy, cough and thoracic pains, and right heart failure that appeared one month after a clandestine abortion. Transthoracic echocardiography found several vegetations on the tricuspid valve with massive tricuspid regurgitation. The chest X-ray showed bilateral excavated lung abscesses and condensation areas. Blood culture was not done and broad-spectrum antibiotic therapy was given. She was apyretic after 10 days. However, the massive tricuspid regurgitation with right heart failure persisted. She was discharged from hospital after 40 days of treatment. Although rare, infective endocarditis is one of the more serious complications of gynaecological procedures, particularly clandestine abortion. Therefore any young girl with persistent fever must be suspected of clandestine abortion.

Pharmacokinetics and pharmacodynamics of oral and intravenous cefetamet in dog.

The pharmacokinetic (PK) and pharmacodynamic (PD) properties of intravenously (IV) administered cefetamet-Na and per os (PO) administered cefetamet pivoxil were investigated in eighteen healthy dogs at three different dose levels. The three doses for IV cefetamet-Na were 95, 190 and 380 mg, while those for oral cefetamet pivoxil were 125, 250 and 500 mg (both equivalent to 90, 180 and 360 mg of cefetamet). An efficacy predictor, measured as the ratios of the time that the concentration of the free drug is over the MIC90 (T > MIC90) and the dosing interval (f% T > MIC90) of IV and PO administration were calculated. The PK parameters' maximum concentration (C max), half-life (t 1/2) and area under the curve (AUC0-t ) after three IV doses were 42.85 ± 11.79 µg/mL, 1.66 ± 0.36 h and 80.10 ± 28.92 mg h/L (95 mg); 93.50 ± 30.51 µg/mL, 1.47 ± 0.13 h and 1.47 ± 0.13 mg h/L (190 mg); 185.74 ± 113.83 µg/mL, 1.60 ± 0.38 h and 263.20 ± 73.27 mg h/L (380 mg). After PO administration, the C max, t 1/2 and AUC0-t at three doses were 9.25 ± 1.02 µg/mL, 1.79 ± 0.50 h and 31.90 ± 4.76 mg h/L (125 mg); 9.75 ± 1.77 µg/mL, 1.93 ± 0.65 h and 42.69 ± 8.93 mg h/L (250 mg); 15.55 ± 6.65 µg/mL, 2.02 ± 0.54 h, and 68.72 ± 24.11 mg h/L (500 mg). The IV f% T > MIC90 was greater than PO f% T > MIC90 when MIC90 was within the range of 0.25-256 mg/L.

[Phase I clinical trial on the safety of injectable cefetamet sodium with a single dose in healthy volunteers].

OBJECTIVE: To investigate the safety and maximum tolerable dosage of injectable cefetamet sodium Sixty healthy volunteers were enrolled in this study. with a single infusion in Chinese healthy volunteers. METHODS: A double-blinded, randomized, placebo-controlled design was adopted. Eight dosages ranging from 100 mg to 5 000 mg were tested. The pharmacokinetics of the drug was analyzed using a Latin square three-cross self-controlled design, with 12 healthy volunteers receiving 500 mg, 1 000 mg and 2 000 mg of injectable cefetamet sodium in a randomized sequence. Blood and urine samples were collected and analyzed using high performance liquid chromatography with UV detection. The main pharmacokinetics parameters were calculated with DAS2.0 software. RESULTS: 59 healthy volunteers completed the tolerance tests. Clinical adverse reactions occurred in 22.73% of participants in the test group and 6.67% of participants in the placebo group; but the difference was not statistically significant. Common adverse events included infusion pain and dizziness. Rare adverse events such as palpitations, diarrhea and rash occurred in participants in the test group. All of the adverse reactions were mild. Abnormal laboratory test results occurred in 43.18% participants in the test group and 53.33% participants in the placebo group; again the difference was not statistically significant. Common abnormal laboratory test results included abnormal bowel flora, stool abnormalities, abnormal urine and elevated serum potassium. After a single infusion of 500 mg, 1 000 mg and 2 000 mg of injectable cefetamet sodium, peak concentration of the drug at 0.5 h reached (37.92 +/- 7.43), (74.90 +/- 10.67) and (148.54 +/- 31.63) mg/L, with areas under concentration-time curve of (72.08 +/- 14.98), (144.28 +/- 24.57) and (286.66 +/- 54.25) (mg x h)/L, respectively. Their elimination half-life was (2.03 +/- 0.38), (2.04 +/- 0.26), and (2.12 +/- 0.26) h, respectively. The disposition of cefetamet was presented as a two-compartment model with linear kinetics. The 24-hour urinary accumulation excretion was 76.6%-67.5%. CONCLUSION: The maximum single tolerated dose of injectable cefetamet sodium is 5 000 mg. The pharmacokinetics is a two-compartment model with linear kinetics within a dose range 500-2 000 mg.

[Cutaneous infection with Aggregatibacter actinomycetemcomitans]. / Kutane Infektion mit Aggregatibacter actinomycetemcomitans.

BACKGROUND: Aggregatibacter actinomycetemcomitans is a small, gram-negative, non-motile, coccobacillus. Aggregatibacter actinomycetemcomitans is known to cause periodontal disease and to be associated with actinomycosis. CASE REPORT: We report a patient developed a chronic wound following trauma about the right heel. The lesion resolved after oral antibiotic therapy with cefpodoxime und surgical debridement. Bacterial cultures grew abundant Aggregatibacter actinomycetemcomitans, but no actinomyces species. OBJECTIVE: The importance of Aggregatibacter actinomycetemcomitans in chronic wounds needs to be explored.

Multicenter, double-blind, randomized clinical trial of parenterally administered Cefoselis versus Cefepime for the treatment of acute bacterial infections.

AIM: This study aims to evaluate the clinical efficacy and safety of intravenous Cefoselis injection for the treatment of acute moderate and severe bacterial infections. PATIENTS AND METHODS: A multicenter, double-blind, randomized clinical trial was carried out using Cefepime as control. Patients received 1.0 g of either Cefoselis or Cefepime for moderate infections or 2.0 g for severe infections at an interval of 12 hours for 7 to 14 days. A total of 276 patients (138 with Cefoselis, 138 with Cefepime) with respiratory or urinary tract infections were enrolled in the study. Up to 137 and 124 patients receiving Cefoselis and 132 and 125 patients receiving Cefepime were eligible for the ITT (intent to treat) and PP (per protocol) analyses, respectively. RESULTS: At the end of the treatment, the cure rates and effective rates were 59.68% (74/124) and 93.55% (116/124) with Cefoselis, and 56.00% (74/124) and 90.40% (116/124) with Cefepime. The bacterial eradication rates of the two groups were 90.32% and 93.85%, respectively. No statistical differences were observed on the above-mentioned parameters between the two groups (all p > 0.05). Adverse events, mainly mild aminotransferase elevation and mild leukopenia, were observed in 11.59% (16/138) and 13.77% (19/138) of patients with Cefoselis and Cefepime, respectively (p > 0.05). CONCLUSIONS: Cefoselis is an effective and safe choice against acute moderate and severe respiratory infections and UTI (urinary tract infection).

Impact of unlabeled French antibiotic guidelines on antibiotic prescriptions for acute respiratory tract infections in 7 Pediatric Emergency Departments, 2009-2012.

From November 2009 to October 2012, implementation of guidelines, unlabeled by the French Agency of Health Products, changed the categories of antibiotics prescribed for acute respiratory tract infections in 7 pediatric emergency departments. During the study, 36,413 acute respiratory tract infections-related antibiotic prescriptions were prescribed. Amoxicillin prescriptions rose from 30.0% to 84.7%, while amoxicillin-clavulanate and cefpodoxime prescriptions decreased to 10.2% and 2.5%, respectively.