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Prospective, multicenter, randomized, open-label, parallel-group study.
Antibiotic utilisation during the year 2000 was observed using the ATC/defined daily doses (DDD) methodology (ATC code-J01). Drug-usage data was expressed in numbers of DDD/100 bed-days and the DU90% profile.
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Tonsillopharyngitis caused by group A beta-hemolytic streptococci (GABHS) is common in pediatric clinical practice. Standard penicillin therapy may be associated with poor compliance, penicillin tolerance in GABHS and microbial copathogenicity. Alternative treatments are available (e.g. oral cephalosporins), and data suggest that shorter courses of these agents may be effective.
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The present research work is focused on the development of solid lipid nanoparticles of cefuroxime axetil (CA-SLN) for its enhanced inhibitory activity against Staphylococcus aureus produced biofilm. CA-SLN was prepared by solvent emulsification/evaporation method using single lipid (stearic acid (SA)) and binary lipids (SA and tristearin (TS)). Process variables such as volume of dispersion medium, concentration of surfactant, homogenization speed and time were optimized. The prepared SLN were characterized for encapsulation efficiency, drug polymer interaction studies (DSC and FT-IR), shape and surface morphology (SEM and AFM), in vitro drug release, stability studies and in vitro anti biofilm activity against S. aureus biofilm. Among the process variables, increased volume of dispersion medium, homogenization speed and time led to increase in particle size whereas increase in surfactant concentration decreased the particle size. SLN prepared using binary lipids exhibited higher entrapment efficiency than the single lipid. DSC and FT-IR studies showed no incompatible interaction between drug and excipients. CA-SLN showed two folds higher anti-biofilm activity in vitro than pristine CA against S. aureus biofilm.
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Cefuroxime-axetil, the 1-acetoxyethyl ester of cefuroxime, is a prodrug for oral administration. The indication of this new formulation in the treatment of community acquired RTI required an updating of its activity against respiratory pathogens. A total of 260 isolates were included in a study using MIC determination (agar dilution technique): the mode MICs for Haemophilus spp., Branhamella catarrhalis, streptococci, S. pneumoniae ranged from 0.016 to 0.5 mg/l; no difference was noted between beta-lactamase producers and non producers in Haemophilus and B. catarrhalis; coagulase positive staphylococci, E. coli, K. pneumoniae isolated from RTI exhibited mode MICs not exceeding 4 mg/l (except for methicillin-R staphylococci mode MIC greater than 128 mg/l). Simultaneously the pharmacokinetic parameters were determined in healthy volunteers after a loading dose (500 mg) of the drug: 7 consecutive samples collected after a light meal provided the following data: Cmax = 7.77 +/- 2.2 mg/l; Tmax = 2.33 +/- 0.23 hrs; t1/2 beta = 1.18 +/- 0.19 hrs; AUC = 22.17 +/- 6.4 h.mg/l. Cmax and AUC were half of these values after administration of 250 mg. These results, together with the known intrinsic beta-lactamase stability of cefuroxime, should ensure sufficient in vivo concentrations and effective in vivo antibacterial activity against most respiratory pathogens after oral administration of cefuroxime-axetil.
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In this three-year prospective study, 137 children with acute otitis media (AOM) that had not responded after one or two empiric antimicrobial treatment courses (termed persistent AOM) underwent tympanocentesis to determine additional antimicrobial therapy based on in vitro susceptibility testing of the bacterial isolate(s). One hundred eleven children with AOM not previously treated are described for comparison. In the persistent AOM group middle ear aspirates grew Streptococcus pneumoniae (24%), Haemophilus influenzae (7%), Brahamella catarrhalis (7%), Streptococcus pyogenes (6%), Staphylococcus aureus (5%), two pathogens (3%) or no bacterial growth (49%); pathogens in previously untreated AOM were similar but fewer patients (30%) had no bacterial growth. After tympanocentesis additional antimicrobial therapy for persistent AOM patients utilizing drugs shown to be effective in vitro against the isolated pathogen failed to produce clinical resolution of infection in 27 (28%) of ears. Differing clinical efficacy was observed with various antimicrobials: amoxicillin (57% failure); trimethoprim/sulfamethoxazole (75% failure); cefaclor (37% failure); cefixime (23% failure); amoxicillin/clavulanate (12% failure); and cefuroxime axetil (13% failure). Presumptive clinical cure for previously untreated AOM patients was similar to that for untreated AOM except for fewer amoxicillin failures (30%). We conclude that clinical failure in persistent AOM occurs (1) even when no pathogen is isolated from tympanocentesis (50% of patients) and (2) despite demonstrated in vitro activity against culture-proved pathogens.
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No significant differences were identified between doxycycline and cefuroxime axetil in the treatment of European patients with erythema migrans. The frequency of nonspecific symptoms in patients did not exceed that of a control group at > or =6 months after enrollment. We advocate inclusion of appropriate non-Lyme disease control groups in future studies in which nonspecific subjective symptoms are assessed after antibiotic therapy.
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Eighty-seven hospitalized adult patients, positively identified as having CDAD, were reviewed retrospectively to determine the risk factors and cost implications of CDAD.
Resistance among common pediatric respiratory tract pathogens to macrolides occurs through two main mechanisms, alteration of the target site and active efflux. Although resistance patterns vary by geographic region, the widespread use of macrolides has contributed to the emergence of both types of macrolide-resistant organisms. Conditions that favor the selection and proliferation of resistant strains include children with repeated, close contact who frequently receive antimicrobial treatment or prophylaxis, such as children who attend day care. Recent US surveillance data show that 20 to 30% of S. pneumoniae are resistant to macrolides, with approximately two-thirds of macrolide-resistant strains associated with an efflux mechanism and the remainder associated with a ribosomal methylase. Additionally, although less well-known, virtually all strains of H. influenzae have an intrinsic macrolide efflux pump. As resistance to macrolides has increased, clinical failures have resulted, and these agents are no longer considered appropriate for empiric first line antimicrobial therapy of acute otitis media and sinusitis unless patients are truly penicillin-allergic. Therefore, other antimicrobials are recommended for the empiric treatment of children with respiratory tract infections, including higher doses of amoxicillin and amoxicillin/clavulanate (90 mg/kg/day amoxicillin), cefuroxime axetil and intramuscular ceftriaxone.