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Among orally administered cephalosporins, aminopenicillins (+/- clavulanate), and macrolides, cefditoren was the most potent agent against Haemophilus influenzae (MIC(50/90), < or =0.008/0.03 microg/mL; 316 isolates including 100 beta-lactamase-positive and 10 beta-lactamase-negative ampicillin-resistant [BLNAR]) and was 32-, 64-, and 512-fold more potent than cefdinir, cefuroxime, and cefprozil, respectively. Cefditoren (MIC(50), 0.03 microg/mL) was also > or =32-fold more active against BLNAR phenotypes, although newer macrolides provided complete coverage against these strains. All Moraxella catarrhalis isolates were inhibited by cefditoren (0.5 microg/mL), including beta-lactamase producers (MIC(50), 0.12 vs < or =0.008 microg/mL). Cefditoren retains potent activity against respiratory tract isolates in the United States, including those with resistance phenotypes.
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Cefdinir is a new, extended-spectrum, orally active, third-generation cephalosporin that is resistant to bacterial beta-lactamase production. To evaluate efficacy and safety of the antibiotic in maxillary sinusitis, its use was compared with amoxicillin/clavulanate (amox/clav), which is a well-accepted beta-lactamase-resistant antibiotic. In this investigator-blinded multicenter phase III clinical study, 569 patients were randomly assigned to one of three treatment regimens: one daily dose of cefdinir 600 mg (OD), cefdinir 300 mg every 12 h (BD), and amox/clav 500/125 mg every 8 h. All antibiotics were administered orally for 10 days. Maxillary sinusitis was documented by typical clinical signs and symptoms and was confirmed by X-ray imaging. Before treatment, the genus and species of any pathogens were determined from sinus aspirates. Cultures were tested for beta-lactmase production and in vitro resistance to cefdinir and amox/clav. The effectiveness of antibiotic treatment was evaluated 7-14 days after therapy and whether or not recurrent clinical symptoms or persistent infection was determined 21-35 days post-therapy. The appearance of any adverse events was classified as associated or not associated with the medication of the study. Present findings showed that the in vitro susceptibility of pathogens to cefdinir and amox/clav was similar. Cefdinir OD or BD was therapeutically as effective as or better than amox/clav, although cefdinir BD was not as useful as amox/clav clinically. Cefdinir OD and BD and amox/clav were well tolerated. The statistical incidence of adverse events was the same among the three treatment groups, although cefdinir OD treatment had significantly fewer treatment discontinuations due to adverse events than BD and amox/clav.
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Facial vein thrombophlebitis is an uncommon complication of sinusitis. In cases where periorbital swelling complicating sinusitis is diagnosed, clinical findings of swelling and erythema extending beyond the orbital region into the cheek should alert the physician about this unusual complication and the need for further contrast-enhanced imaging and venography. The radiologist must be particularly careful in the evaluation of vascular structures of the face and neck in these children. CT and MRI with contrast material and MR venography are studies that clearly demonstrate the vascular anatomy and possible complications. However, MR venography confirms flow abnormalities within the venous system with the advantage of avoiding radiation exposure to the pediatric patient.
A cefdinir dosage of 25 mg/kg daily would be ineffective for treatment of acute otitis media caused by penicillin-nonsusceptible S. pneumoniae strain.
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The in-vitro activity of cefdinir (FK482), an orally absorbed aminothiazolyl cephalosporin, was compared with that of cefuroxime, cefixime, cephalexin, cefaclor and co-amoxiclav. Cefdinir was highly active against Staphylococcus aureus, inhibiting 90% of strains at 0.03 mg/L. The respiratory pathogens Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis were also susceptible (MIC90 less than or equal to 1 mg/L). The common members of the Enterobacteriaceae were susceptible (MIC90 less than or equal to 1 mg/L), but those possessing chromosomal beta-lactamases were more resistant. Cefdinir appeared highly stable to the TEM-1 and SHV-1 beta-lactamases with only relatively minor degrees of hydrolysis being seen with TEM-3, -5 and -9.
Two dosage regimens of cefdinir were compared with amoxicillin/clavulanate for the treatment of suppurative acute otitis media (AOM) in children.
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Cefdinir is a second-line alternative to first-line antimicrobial agents, with convenient once- or twice-daily dosing in the treatment of upper and lower respiratory tract infections and skin and skin-structure infections. Similar to other oral expanded-spectrum cephalosporins, cefdinir has activity against common pathogens of the respiratory tract and skin and is stable in the presence of many beta-lactamases. The clinical choice of an oral expanded-spectrum cephalosporin will be based on patient acceptance, frequency of administration, and cost.
Three new, orally administered cephalosporins (BK-218, cefdinir, RU29246) were tested against 13 representative strains of Legionella. Cefdinir was most active [50% minimum inhibitory concentration (MIC50), 1 micrograms/ml], a potency comparable to the reference drug cefixime and eightfold less active than erythromycin. BK-218 was the least active cephalosporin (MIC50, 8 micrograms/ml) or 100-fold less potent than rifampin. These investigational cephems appear poorly suited by activity assays for Legionellosis therapy.
To describe a man with impetigo localized to a unilateral dermatome and review the clinical features of other patients with zosteriform Staphylococcus aureus cutaneous infection.
FK482 is a new orally active cephem antibiotic which offers some advantages over the commercially available oral beta-lactam antibiotics. It displayed a broad spectrum of activity in vitro against stock strains of Gram-positive and Gram-negative aerobes and anaerobes. FK482 was more active in vitro than cefixime (CFIX), cefaclor (CCL) or cephalexin (CEX) against clinical isolates of Gram-positive organisms such as methicillin-sensitive Staphylococcus aureus, coagulase-negative Staphylococci including Staphylococcus epidermidis and strains of the Streptococcus group. Moderate activity was found against methicillin-resistant S. aureus and Enterococcus faecalis. Against clinical isolates of many Gram-negative species, including opportunistic pathogens, FK482 had good in vitro activity similar or slightly inferior to that of CFIX but superior to that of CCL or CEX. However, it was clearly inferior to CFIX in activity against Serratia marcescens, and was inactive against Pseudomonas aeruginosa. Strains of S. aureus resistant to methicillin were moderately susceptible to FK482. All tested strains of Klebsiella pneumoniae resistant to CCL and CEX were susceptible to FK482, as were all the strains of Escherichia coli, Proteus mirabilis, Haemophilus influenzae and Branhamella catarrhalis resistant to amoxicillin (AMPC). FK482, like CFIX, was relatively stable to all type of beta-lactamases except Bacteroides fragilis and its stability was superior to that of CCL or CEX. The antibacterial activity of FK482 against CSH2 strains containing ampicillin-resistance plasmids was not affected by the presence of the ampicillin resistance determinants. FK482 showed higher affinity for the penicillin-binding proteins (PBPs) (3, 2 and 1) of S. aureus than did CFIX, CCL and CEX. FK482 also showed very high affinity for the PBPs (2 and 3) of E. faecalis and PBPs (3, 1a, 4, 2 and 1 bs) of E. coli. The bactericidal activity of FK482 against S. aureus was almost as strong as that of AMPC and superior to that of CCL or CEX. Against Gram-negative bacteria such as E. coli, K. pneumoniae and P. mirabilis, FK482 was similar to CFIX and superior to CCL and CEX in bactericidal activity.
Cefdinir (CFDN), a new oral cephalosporin, was administered to 10 patients with various infections and the following results were obtained. 1. Clinical responses in 10 patients (1 patient with rhinitis, 2 with sinusitis, 1 with pharyngitis, 1 with tonsillitis, 4 with scarlet fever and 1 with abscess) were excellent in 6 and good in 4 with an efficacy rate of 100%. 2. Eleven species of bacteria were isolated (3 of Staphylococcus aureus, 6 of Streptococcus pyogenes and 2 of Haemophilus influenzae) and all of them were eradicated by the treatment with CFDN. 3. No side effects or abnormal laboratory test values were noted. None of the patients refused to take the drug.
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This study demonstrated that empiric coverage of USSSIs with cephalosporin therapy remains an appropriate clinical strategy. MRSA infections responded well in both arms of the study, suggesting that the choice of a cephalosporin did not adversely affect patient outcome. However, cephalosporins do not have accepted, clinically relevant in vitro activity against MRSA. Hence, the clinical response rates seen in this study against MRSA infections must be interpreted with caution. Cefdinir was more highly rated than cephalexin in a composite usefulness assessment.
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This analysis of the results of 7 trials compared the taste and smell acceptability scores of cefdinir oral suspension and 4 other pediatric antibiotic oral suspensions--amoxicillin/clavulanate potassium, cefprozil, azithromycin, or generic amoxicillin--using a visual smile-face scale.
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In this double-blind, randomized, multicentered, parallel-group study, patients received once-daily cefdinir 600 mg, twice-daily cefdinir 300 mg, or twice-daily cefuroxime axetil 250 mg for 10 days. Primary efficacy measures were microbiologic eradication rate, by pathogen and by patient, and clinical response rate, by patient.
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We evaluated the in-vitro and in-vivo antibacterial activities of R-95867 and CS-834, a new oral carbapenem which is an ester-type prodrug of R-95867. Against Gram-positive bacteria, R-95867 was as active or two to 256 times more active than cefpodoxime, cefdinir, cefditoren and ofloxacin, while its activity was similar to or two to eight times lower than that of imipenem. Against most Gram-negative bacteria it was as active or two to 1024 times more active than the other compounds tested. Against Helicobacter pylori it was two to 64 times more active than orally active anti-H. pylori agents, i.e. amoxycillin, clarithromycin and lansoprazole. It also showed potent bactericidal activity against Staphylococcus aureus and Escherichia coli. R-95867 induced a spherical form in E. coli and showed high affinity for PBP 2 in E. coli. Against systemic infections in mice caused by various bacteria, CS-834 showed an excellent protective effect and its in-vivo efficacy correlated well with the in-vitro activity of R-95867. These results suggest that CS-834 may be effective in the therapy of various bacterial infections.
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A high prevalence of penicillin-binding protein gene-mutated (PGM) strains of Haemophilus influenzae should be taken into account when treating otitis media in children.
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Descriptive & experimental studies were conducted in seven tertiary hospitals in Thailand. The specimens from maxillary sinuses were taken for bacterial cultures either by maxillary sinus tap or endoscopically directed middle meatus swabs in patients with clinically diagnosed ABRS. Antimicrobial sensitivity was performed and antibiotics were prescribed according to the results of antimicrobial sensitivity or the Thai CPG of ABRS.
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A 64-year-old man had a complaint of metamorphopsia in the left eye. Visual acuity was 0.5 in the left eye. Fluorescein angiography and indocyanine angiography showed juxtafoveal occult choroidal neovascularization (CNV) in the left eye, and pegaptanib sodium 0.3 mg was administered once every 6 weeks. After 4 months, visual acuity improved to 0.8. After 8 months follow-up, optical coherence tomography (OCT) showed subretinal fluid (SRF) and retinal pigment epithelium (RPE) irregularity. Visual acuity was 0.4. We recommended further pegaptanib sodium injections, but the patient did not consent to the treatment. Onset of cellulitis of the left toe occurred 1 week before the scheduled visit after 9 months. The patient was treated with loxoprofen sodium (nonselective COX inhibitor) and cefdinir for 7 days. At 2 weeks after onset of cellulitis, SRF had disappeared and OCT showed improvement of RPE irregularity.
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A pharmacokinetic study was performed on cefdinir (CFDN, FK482) 5% fine granules for pediatric use, and pharmacokinetic parameters were calculated. 1. Twenty school children were administered orally a dose level of 3 mg/kg of CFDN fine granules either at 30 minutes before meal (14 children) or 30 minutes after meal (6 children). Plasma concentrations and urinary recovery rates of CFDN were measured. Tmax, Cmax, T 1/2 and urinary recovery rate (0-8 hours) following the administration before meal were 2.00 +/- 0.00 hours, 1.14 +/- 0.11 micrograms/ml, 1.63 +/- 0.14 hours and 23.68 +/- 2.92%, respectively, Tmax, Cmax, T1/2 and urinary recovery rate following the administration after meal were 3.67 +/- 0.33 hours, 0.71 +/- 0.06 micrograms/ml, 2.18 +/- 0.16 hours and 21.76 +/- 2.36%, respectively. Earlier Tmax and higher Cmax were observed when the drug was administered before meal than when administered after meal. There was no statistically significant difference between the 2 groups in urinary recovery rates. However, statistically significant difference was found between the 2 groups when the cross-over technique was used in 6 school children. Nineteen younger children (before meal) and 6 younger children (after meal) were administered with the drug in the same way, and several parameters were measured. Tmax, Cmax, T1/2 and urinary recovery rate following the administration before meal were 2.11 +/- 0.11 hours, 0.98 +/- 0.14 micrograms/ml, 1.71 +/- 0.23 hours and 23.60 +/- 1.72%, respectively, Tmax, Cmax, T1/2 and urinary recovery rate following the administration after meal were 3.33 +/- 0.42 hours, 0.47 +/- 0.14 micrograms/ml, 2.35 +/- 0.27 hours and 12.24 +/- 2.02%, respectively. Earlier Tmax, higher Cmax and higher urinary recovery rate were observed when the drug was administered before meal than when administered after meal. Seven infants (before meal) and 8 infants (after meal) were administered with the drug in the same way, and several parameters were measured. Tmax, Cmax, and T1/2 following the administration before meal were 4.00 +/- 0.62 hours, 0.61 +/- 0.13 micrograms/ml and 3.14 +/- 0.62 hours, respectively, Tmax, Cmax and T 1/2 following the administration after meal were 3.75 +/- 0.25 hours, 0.79 +/- 0.13 micrograms/ml and 2.44 +/- 0.42 hours, respectively. These was no statistically significant difference between the 2 groups. 2. Twenty one school children were administered orally with CFDN fine granules at 30 minutes before meal ata dose level of either 3 mg/kg (14 children) or 6 mg/kg (7 children). Plasma concentrations and urinary recovery rate of CFDN were measured.(ABSTRACT TRUNCATED AT 400 WORDS)
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ss-Lactamase-producing (BLP) strains with the bla gene were identified in 16 (2.5%) of isolates. PGM strains were identified in 279 (43.3%) isolates. There were 242 (37.6%) PGM1-nonBLP strains with mutations in variable mutated locus of ftsI, 35 (5.4%) PGM2-nonBLP strains with mutations in highly mutated locus of ftsI, 2 (0.3%) BLP-PGM strains with mutations in ftsI and producing ss-lactamase. BLP-nonPGM strains producing ss-lactamase without mutations in ftsI were identified in 14 (2.2%) isolates. MICs of PGM1-nonBLP strains to AMP were 0.5-2.0 microg/ml. The MIC(90) of CDN to the PGM1-nonBLP strains was lowest (0.06 microg/ml). Proportions of PGM1-nonBLP strains rapidly increased during 1999 to 2002 and then decreased in 2003. In contrast, PGM2-nonBLP strains increased in 2003.
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Investigator-blind, randomized controlled trial.
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Hydrolytic degradation products of cefdinir were studied in acidic (pH 1), neutral (pH 6), and basic (pH 9) solutions. Seven major degradation products were isolated by preparative and/or high-performance liquid chromatography and characterized by UV, IR, 1H-NMR, and mass spectra. To clarify degradation pathways in each pH solution, kinetic and product analyses during hydrolysis of cefdinir were carried out along with the followup reaction of representative degradation products. Cefdinir was shown to degrade via two major degradation routes: beta-lactam ring-opening and pH-dependent isomerizations (lactonization, epimerization at C-6 or C-7, syn-anti isomerization of N-oxime function).
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The antimicrobial products tested were amoxicillin/clavylanate, cefpodoxime, cefdinir, cefditoren, cefprozil, cefuroxime, cefixime, azithromycin, and clarithromycin. The bacterial species comprised 70 penicillin-susceptible, 68 penicillin-intermediate, and 69 penicillin-resistant strains of Streptococcus pneumoniae; 46 beta-lactamase-positive and 54 beta-lactamase-negative strains of Haemophilus influenzae; 49 strains of Moraxella catarrhalis; and 100 methicillin-sensitive strains of Staphylococcus aureus (MSSA). Strains were isolated from clinical specimens obtained from outpatient-acquired infections in 1 clinical center in the Northeast and 1 in the north-central area of the United States within the past 2 years. National Committee for Clinical Laboratory Standards microdilution MIC methodology was used. PK/PD breakpoints were obtained from previously published studies and were based on blood values.
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beta-Lactamase production was demonstrated in 67 (28.8%) of the H. influenzae isolates and varied by isolation site (38% acute otitis media, 36% sinusitis, and 21% lower respiratory tract infections). Regarding susceptibility, the rank order of the tested antimicrobials was ceftriaxone = cefixime (100%) > cefpodoxime (99.6%) > ceftibuten = amoxicillin/clavulanic acid (99.1%) > cefdinir (98.7%) > cefuroxime (97.4%) > cefprozil (93.1%) > cefaclor (92.3%) > amoxicillin (63.1%). The most active agents based on pharmacodynamic assessment (50% fT > MIC) were cefpodoxime (98.9%), ceftibuten (95.3%), and high-dose amoxicillin/clavulanic acid (90.4%). Several amoxicillin regimens also achieved a high likelihood of pharmacodynamic target attainment (91.8- 98.6%) when beta-lactamase-positive strains were excluded from the analysis.