Of the 175 enrolled patients, urine was obtained by clean catch in 138 (79%), catheterization in 35 (20%), first-pass void in 1 (0.6%), and undocumented method in 1 (0.6%). Pyuria was demonstrated in 164 patients (94%), but only 97 (55%) had a positive urine culture. The combination of pyuria and a positive urine culture confirmed UTI in 90 patients (51%). The most commonly prescribed antibiotics were cefdinir in 103 patients (59%), trimethoprim/sulfamethoxazole in 40 (23%), and ciprofloxacin in 23 (13%). The median duration of prescribed therapy was 10 days (interquartile range, 7-10 days). Treatment duration was correlated negatively with age (r = -0.53, P < 0.01).
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cefdinir is safe and effective, shorten the course of treatment in the treatment of mild to moderate bacterial community acquired pneumonia.
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The clinical efficacy of cefditoren pivoxil (CDTR-PI) was evaluated for 43 pediatric patients with acute otitis media or acute sinusitis. The causative organisms were identified and their susceptibilities to 6 oral beta-lactam antibiotics were measured; ampicillin (ABPC), cefaclor (CCL), cefdinir (CFDN), cefditoren pivoxil (CDTR-PI), cefteram pivoxil (CFTM-PI) and cefpodoxime proxetil (CPDX-PR). The ages of 43 patients were distributed from 4 months to 10 years and 7 months, and especially children under 4 years accounted for 72% (31 cases). In 22 cases (51%), Haemophilus influenzae or Streptococcus pneumoniae were identified as the pathogens, but in 18 cases, no causative organisms were defined. Treatment by CDTR-PI was successful in 12 cases out of 15 evaluable cases in which H. influenzae or S. pneumoniae were identified as the main causative organisms. From the susceptibility testing of them, some strains of H. influenzae were found to be ABPC-resistant and some strains of S. pneumoniae were benzylpenicillin (PCG)-resistant. To support above clinical evaluation of CDTR-PI, susceptibility testings on clinically isolated H. influenzae (81 strains) and S. pneumoniae (79 strains) were performed using above mentioned 6 oral beta-lactam antibiotics. The MIC80s against H. influenzae were; CDTR-PI 0.06 microgram/ml, CCL 2 micrograms/ml, CPDX-PR 0.125 microgram/ml, CFTM-PI 0.03 microgram/ml, CFDN 1 microgram/ml and ABPC 1 microgram/ml. Those against S. pneumoniae were; CDTR-PI 0.5 microgram/ml, CCL > 4 micrograms/ml, CPDX-PR 2 micrograms/ml, CFTM-PI 1 microgram/ml, CFDN 2 micrograms/ml and ABPC 1 microgram/ml. From those results, it was concluded that CDTR-PI or CFTM-PI may be preferable for the treatment of acute otitis media and acute sinusitis in children.
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The most frequently identified pathogens in our patients were ESBL-producing E coli and E faecalis. Fosfomycin tromethamine and nitrofurantoin showed a good antimicrobial activity against UTI pathogens. They may represent good options for the empiric treatment of patients with UTI.
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233 H. influenzae isolates obtained from pediatric outpatients with acute otitis media (n = 55), sinusitis (n = 58), or lower respiratory tract infections ( n = 120) from 1 November 2004 to 30 April 2005 were characterized for beta-lactamase production and susceptibility to a panel of 10 beta-lactam antimicrobials. 5000 concentration-time profiles were simulated for US FDA-approved doses of oral amoxicillin, amoxicillin/clavulanic acid, cefpodoxime, cefprozil, ceftibuten, and cefuroxime using pharmacokinetics and weights of 5-year old male children. The probability of attaining free drug concentrations above the minimum inhibitory concentration (MIC) for 50% of the dosing interval (50% fT > MIC) was assessed for each regimen against this population of H. influenzae.
The in vitro activity of cefdinir, an oral aminothiazolyl hydroxyimino cephalosporin was compared with that of cefixime, cefpodoxime, cefaclor, cephalexin, ciprofloxacin, ofloxacin, oxacillin, ampicillin, vancomycin and trimethoprim-sulfamethoxazole against 279 gram-positive and gram-negative recent clinical isolates from adult and pediatric patients. Cefdinir was the most active drug among the cephalosporins against oxacillin-sensitive Staphylococcus aureus and coagulase-negative staphylococci, Streptococcus pneumoniae, S. pyogenes, Escherichia coli and Moraxella catarrhalis (MIC90 0.015-2 mg/l). Cefixime was the most active agent against Hemophilus influenzae, Klebsiella pneumoniae, K. oxytoca, Proteus mirabilis and P. vulgaris (MIC90 < 0.015-0.125 mg/l). The activity of cefpodoxime was better than that of cefixime against S. pneumoniae and oxacillin-sensitive staphylococci (MIC90 0.25-8 vs. 0.5-32 mg/l), similar to cefixime against S. pyogenes (MIC90 0.06 mg/l) and not as good as cefixime against H. influenzae, M. catarrhalis, Klebsiella spp. and Proteus spp. (MIC90 < 0.015-0.25 vs. 0.125-0.5 mg/l). The activity of cefdinir was greater than that of the other cephalosporins against Enterococcus faecalis (MIC90 16-32 vs. > 64 mg/l). None of the cephalosporins were active against methicillin-resistant, coagulase-positive or -negative staphylococci or Pseudomonas aeruginosa (MIC90 > 64 mg/l). Overall, the susceptibilities of adult and pediatric isolates were similar. Kinetic kill curves demonstrated rapid and similar killing at 6 h by cefdinir, cefixime, cefpodoxime and ofloxacin. At 24 h at 1 x MIC, the least regrowth was observed with cefdinir and cefpodoxime; at 2 x MIC, suppression of growth was similar with all four drugs.
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A first step in management decisions regarding otitis media must focus on accurate diagnosis to distinguish normal from acute otitis media (AOM) from otitis media with effusion (OME) or a retracted tympanic membrane without middle ear effusion. There are several classification schemes for AOM that may impact management decisions: patients with acute, persistent, recurrent, or chronic AOM may have a different distribution of bacterial pathogens and a different likelihood of success from antimicrobial therapy. Patient age, prior treatment history and daycare attendance are other important variables. The natural history of AOM without antibiotic treatment is generally favorable; however, from the few studies available, this is difficult to quantitate because the diagnosis was infrequently confirmed by tympanocentesis leaving the possibility that many patients entered into these trials may not have had bacterial AOM. Antibiotic choices should reflect pharmacokinetic/pharmacodynamic data and clinical trial results demonstrating effectiveness in eradication of the most likely pathogens based on tympanocentesis sampling and antibiotic sensitivity testing. Thereafter, compliance factors such as formulation, dosing schedule and duration of treatment and accessibility factors such as availability and cost should be taken into account. The increasing prevalence of antibiotic resistance among AOM pathogens and the changing susceptibility profiles of these bacteria should be considered in antibiotic selection. Current best practice recommends amoxicillin for uncomplicated AOM; continuing or switching to an alternative antibiotic based on clinical response after 48 hours of therapy; and selection of second line antibiotics as first line choices when the patient has already been on an antibiotic within the previous month or is otitis prone. Preferred second-line agents frequently noted in various guidelines include amoxicillin/clavulanate, cefdinir, cefpodoxime, cefprozil, and cefuroxime. Three injections of ceftriaxone or gatifloxacin (when approved) or diagnostic/therapeutic tympanocentisis (when approved) become a third-line treatment option. No single antibiotic or management strategy is ideal for all patients.
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This article reviews the structure-activity relationships, biological properties and synthesis of two new oral cephalosporin antibiotics, cefixime (CFIX) and cefdinir (CFDN). Our research into new oral cephalosporin antibiotics began in the late 1970's. The first goal of our research was to discover a new oral cephem possessing similar antibacterial activity and resistance to beta-lactamase as the 3rd generation injectable cephalosporins. We focused our attention on searching for a non-prodrug type cephem, that is, a new parent structure with high intrinsic absorption. We selected ceftizoxime (CZX) as a seed compound due to its relatively high excretion rate (8.5%) in the urine after oral administration to rats. We concentrated our research on the chemical modification of the oxime moiety in CZX based on our hypothesis for oral absorption, and discovered a lead compound with a carboxymethoxyimino group which displayed better urinary excretion (41.0%). Optimization studies led to a new oral cephem, CFIX. However, CFIX shows only low to moderate antibacterial activity against gram-positive bacteria such as S. aureus. Hence, the second goal of our research was to discover a new oral cephem with enhanced activity against gram-positive bacteria. From a consideration of structure-absorption relationships, we studied the activity and absorbability of cephems bearing other acidic functional groups at the oxime moiety of CFIX. As a result, we found a new oral cephem, CFDN with a hydroxyimino group at the 7-position. CFIX has excellent biological properties, displaying potent antibacterial activity against a wide range of gram-positive bacteria except S. aureus and gram-negative bacteria including opportunistic pathogens, high stability towards beta-lactamases and long acting efficacy. CFDN exhibits excellent and well balanced antibacterial activities against gram-positive and gram-negative bacteria. The pharmacokinetic of CFDN in healthy volunteers showed that serum levels were high enough to make CFDN as an effective antibacterial agent. The proposed mechanisms of intestinal absorption of CFIX and CFDN are briefly described. The efficient synthetic methods to CFIX and CFDN were achieved via a common intermediate, 7-amino-3-vinylcephalosporanic acid diphenylmethyl ester from 7-ACA.
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The niosomal formulation could be one of the promising delivery system for cefdinir with improved oral bioavailability and controlled drug release profile.
We studied pharmacokinetics and clinical effects of cefdinir (CFDN), a newly developed oral cephalosporin, and the following results were obtained. 1. Pharmacokinetics of CFDN in 2 patients were investigated. The 2 patients with ages of 8 years (36.5 kg, body weight) and 6 years (26.5 kg, body weight) were administered with 3 mg/kg of fine granules of CFDN on empty stomachs. Peak plasma levels of CFDN were 0.85 microgram/ml in one patient and 0.56 microgram/ml in the other. The 8-hour urinary recovery rate was 21.6% of the administered dose in one and was not calculable in the other. 2. Clinical effects of CFDN were studied in 25 children with various infectious diseases: 11 with acute pharyngitis, 1 with acute tonsillitis, 2 with acute laryngitis, 3 with acute bronchitis, 2 with acute bronchopneumonia, 4 with scarlet fever, 1 with acute otitis media, 1 with acute lymphadenitis. The efficacy rate was 96% (24/25), and the bacteriological eradication rate was 83.3% (10/12). 3. No side effects were noted. Clinical laboratory test values were investigated in 14 patients. There were no seriously abnormal laboratory test findings except a slight elevation of eosinophile and GPT.
The aim of this study was to evaluate the impact of previous antimicrobial exposure on the development of antimicrobial resistance in children with their first urinary tract infection (UTI).
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We presumed that, given its cost-effectiveness and safety, azithromycin can be an attractive option for the treatment of ESBL-producing S. sonnei enteritis in pediatric populations. Although ciprofloxacin is another cost-effective agent, its use in pediatric populations is not recommended.
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One hundred and thirteen strains of Streptococcus pneumoniae (S. pneumoniae) were isolated from the clinical specimens of patients with respiratory tract infections between January and December 1998 in three hospitals in Hokusetsu area of Osaka. We investigated susceptibility of 113 strains of S. pneumoniae to benzylpenicillin (PCG) and other antimicrobial agents and their serotypes. 1) Of the 113 strains of S. pneumoniae isolated, 25.7% were susceptible (PSSP), 51.3% were intermediate (PISP) and 23% were resistant to benzylpenicillin (PRSP). 2) The MICs of cefaclor, cefditoren, cefpodoxime, cefdinir, erythromycin, clindamycin and minocycline were elevated, but the MIC values of cefditoren ranged from < or = 0.03 to 1.0 microgram/ml. The susceptibility of 113 strains to cefditoren was comparatively high. 3) The MIC values of imipenem, meropenem and vancomycin for 81 strains of PISP and PRSP ranged from < or = 0.015 to 1.0 microgram/ml, from < or = 0.015 to 2.0 micrograms/ml and from 0.13 to 0.5 microgram/ml, respectively. The susceptibility of these strains to three antimicrobial agents was superior to that to the other antimicrobial agents examined. 4) Of the 60 strains examined, 19, 6, and 23 serotypes were 30, 25 and 18.3%, respectively. The three serotypes were observed in PISP and PRSP with a high frequency. 5) Isolates of S. pneumoniae were 37.2% for children under 2 years of age and 30.9% for children from 2 to 6 years of age. Most of the strains isolated from these children were resistant.
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Congenital deformities of the labyrinth of the inner ear can be associated with meningitis and varying degrees of hearing loss or deafness. A recurrence of meningitis is due to the development of a fistulous communication between the subarachnoid space and the middle ear cavity, and can prove lethal. An illustrative case of a 4-year-old Japanese girl with bilateral severe hearing loss, recurrent meningitis and malformations of the inner ear and stapes footplate is presented. Removal of the stapes during tympanotomy provoked a gush of cerebrospinal fluid. The defect was repaired successfully, and there has been no further episodes of meningitis to date.
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Dermatologists treat a variety of uncomplicated skin and skin structure infections (uSSSIs) such as folliculitis, impetigo, erysipelas, cellulitis, furuncles, carbuncles, and non-perirectal abscesses. Most uSSSIs are caused by Staphylococcus aureus and Streptococcus pyogenes. The new extended-spectrum cephalosporins (cefdinir, cefpodoxime) offer efficacy against most Gram-positive and Gram-negative pathogens. Despite recently published guidelines, many physicians do not prescribe cephalosporins for uSSSIs out of concern that these agents will produce a hypersensitivity reaction in patients allergic to penicillin. Although the rate of cephalosporin reaction in penicillin-allergic patients is often quoted as up to 10%, this rate does not take into account the 1% to 3% risk for allergy to cephalosporin alone and the nonspecific increased risk of penicillin-allergic patients to develop hypersensitivity to other drugs. When these additional risks are considered, the likelihood of a reaction in known penicillin-allergic patients, especially to most third-generation and extended spectrum cephalosporins, becomes less than 1%. Cephalosporins with side chains unlike those of penicillin or ampicillin side chains are less likely to result in an allergic reaction in penicillin or ampicillin-allergic patients than cephalosporins with similar side chains. Although both cefdinir and cefpodoxime are considered to carry a very low risk of cross reactivity with penicillin or ampicillin, the former demonstrates better activity against S. aureus. Among the late-generation cephalosporins, cefdinir is the most potent oral agent when tested against oxacillin-susceptible staphylococci, 4- to 16-fold more active than cefprozil and cephalexin, respectively.
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To compare the clinical efficacy of a 5-day cefdinir course with a 10-day cefprozil course in the treatment of pediatric acute otitis media (AOM).
The therapeutic activities of orally administered FK041 were evaluated in mouse models of systemic and local infections with a variety of bacteria and were compared with those of cefdinir (CFDN) and cefditoren pivoxil (CDTR-PI). FK041 exhibited potent therapeutic activity against lethal systemic infections induced by intraperitoneally inoculated Staphylococcus aureus, Escherichia coli, and Klebsiella pneumoniae with 50% effective doses (ED50) in the range of 0.20 to 0.36 mg/kg and was more active than CFDN and CDTR-PI. This result correlated well with its in vitro activity. The therapeutic effects of FK041 and reference drugs on murine local infections were evaluated in an in vivo pharmacokinetic model simulating human plasma concentrations for oral administration of 50 mg, 100 mg, and 200 mg. Against murine subcutaneous abscess induced by S. aureus, FK041 was as effective as CFDN and significantly more effective than CDTR-PI in reducing the number of recoverable viable bacteria in the skin at the infection sites. The efficacy of FK041 against murine pneumonia with H. influenzae was comparable to that of CDTR-PI and was superior to that of CFDN in reducing viable bacteria activity in the lungs. These results strongly suggest that FK041 has potential for clinical use against various bacterial infections.
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Four hundred seventy members of the American Society of Pediatric Otolaryngologists (ASPO) and 150 general otolaryngologists from the Florida Society of Otolaryngology (FSO) were surveyed.
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We compared the antimicrobial activity of commercially available oral cephem agents, cefaclor (CCL), cefroxadine (CXD), cefdinir (CFDN), cefixime (CFIX), cefpodoxime (CPDX), cefteram (CFTM), cefcapene (CFPN), and cefditoren (CDTR), against Streptococcus pneumoniae, Haemophilus influenzae, Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pyogenes, and ESBL-producing bacteria isolated from clinical materials in Kansai Medical University Hospital between 2002 and 2003. Based on the Pharmacokinetics/Pharmacodynamics (PK/PD) theory, we determined the concentration of each agent at which the time above MIC (TAM) value was 40% or more, and calculated the rate of efficacy against each type of bacteria. In S. pneumoniae strains, the MIC(50,80,90) values of CDTR were 0.25, 0.5, and 0.5 microg/ml, respectively, lower than those of the other agents, demonstrating the most potent antimicrobial activity. However, the efficacy rate for CDTR calculated based on the PK/PD theory was 58.5%. CFTM showed the highest efficacy rate (66.1%). In H. influenzae strains, the antimicrobial activity of CDTR was most potent, followed by that of CFTM and that of CFPN/CFIX. The MIC90 value of CDTR was lowest (0.25 microg/ml), followed by that of CFTM (0.5 microg/ml). The efficacy rate for CDTR was 100%. This result supports that CDTR frequently eradicates H. influenzae. In E. coli strains, the MIC90 values of the above agents, excluding CCL and CXD, ranged from 0.5 to 1 microg/ml. The antimicrobial activity of CFIX against K. pneumoniae was most potent, followed by that of CFDN/CPDX and that of CFTM. In ESBL-producing bacteria, most agents showed an MIC90 value of more than 4 microg/ml. In S. agalactiae and S. pyogenes strains, all of the agents showed satisfactory MIC values. In methi- cillin-sensitive Staphylococcus aureus (MSSA) strains, CFDN and CXD showed a high efficacy rate, whereas the efficacy rates for the other agents were low. The frequent use of oral agents has increased the number of cephem-resistant bacteria. ESBL-producing bacteria become highly resistant, and the presence or absence of response can be readily evaluated. However, when a mutation of penicillin-binding protein (PBP) occurs, drug resistance is less marked. Therefore, it is difficult to evaluate the treatment response in many cases. In S. pneumoniae strains, the efficacy rates for all of the agents were low in the evaluation using the PK/PD theory, suggesting that a dose higher than the standard dose should be established. Thus, in the future, the efficacy should be evaluated based on the PK/PD theory, appropriate antimicrobial treatment should be administered, and the administration method that does not increase the number of resistant bacteria must be established.
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The synthesis and biological properties of 1beta-methylcarbapenems with 1-methyl-5-oxopyrrolidin-3-ylthio group at the C-2 position were studied. The sodium (1R,5S,6S)-6-[(R)-1-hydroxyethyl]-1-methyl-2-[(R)-1-methyl-5-oxopyrro lidin-3-ylthio]-1-carbapen-2-em-3-carboxylate and its (S)-isomer at the 2-position show potent and well-balanced antibacterial activity. The pharmacokinetic parameters of the pivaloyloxymethyl esters of these two carbapenems were compared in mice. The in vivo potency of these carbapenems was compared with that of cefdinir. Good in vivo efficacy of these ester prodrugs reflected the high and prolonged blood levels in parent drugs achieved after oral administration to mice.
The final analysis included 1033 patients: 530 (51%) before the CPG (pre-CPG) and 503 (49%) after the CPG (post-CPG). Pre-CPG, ceftriaxone (72%) was the most commonly prescribed antibiotic, followed by ampicillin (13%). Post-CPG, the most common antibiotic was ampicillin (63%). The effect of the CPG was associated with a 34% increase in ampicillin use (P < .001). Discharge antibiotics also changed post-CPG, showing a significant increase in amoxicillin use (P < .001) and a significant decrease in cefdinir and amoxicillin/clavulanate (P < .001), with the combined effect of the CPG and ASP leading to 12% (P < 0.001) and 16% (P < .001) reduction, respectively. Overall, treatment failure was infrequent (1.5% vs 1%).
To evaluate the prevalence of beta-lactamase-non-producing ampicillin-resistant strains of H. influenzae with mutations in the ftsI gene encoding penicillin-binding protein 3 (PBP3) among children with otitis media.