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PubMed1983

Double-blind comparative study of two dosage regimens of cefaclor and amoxicillin-clavulanic acid in the outpatient treatment of soft tissue infections.

A total of 88 patients were enrolled in a double-blind comparison of cefaclor and amoxicillin-clavulanic acid for the outpatient treatment of soft tissue infections (abscesses, cellulitis, and impetigo). In 84 clinically evaluable patients, high cure rates were obtained for all treatment groups (64 to 85%). Patients who received amoxicillin-clavulanic acid had a much higher incidence of gastrointestinal side effects than did patients who received cefaclor (34 versus 3%, P less than 0.005). However, only five patients with gastrointestinal reactions to amoxicillin-clavulanic acid had symptoms severe enough to warrant halting the completion of antibiotic therapy.

Adult↗
PubMed1991

Comparative efficacy and safety of cefprozil (BMY-28100) and cefaclor in the treatment of acute group A beta-hemolytic streptococcal pharyngitis.

Cefprozil (BMY-28100) is a semisynthetic cephalosporin with broad-spectrum antibacterial activity and prolonged serum elimination half-life allowing for once-a-day oral administration. In vitro, cefprozil demonstrates excellent activity against Staphylococcus aureus, Streptococcus pyogenes, Haemophilus influenzae, and Moraxella catarrhalis. Cefprozil (500 mg once daily) was compared to cefaclor (250 mg three times daily) in an open, randomized, comparative trial for the treatment of acute group A beta-hemolytic streptococcal pharyngitis. Ninety-four patients were enrolled in this study; 53 patients were evaluable for clinical and bacteriological response assessment. Seventy-eight patients were evaluable for safety assessment. Three patients (all in the cefprozil treatment group) required disenrollment because of side effects, mainly nausea. Clinical and bacteriological responses were comparable for both study drugs. Leukopenia and nausea, the most common side effects observed, were more common in the cefprozil-treated group. Cefprozil appears to be an appropriate alternative to cefaclor for the treatment of acute group A beta-hemolytic streptococcal pharyngitis. However, because of the small number of patients eligible for efficacy assessment, a large type II (beta) error was expected in our study, which may have resulted in a potential failure to detect a difference between both treatment groups. A larger study would be required to determine the proper role of cefprozil in the treatment of group A beta-hemolytic streptococcal infections.

Adolescent↗
PubMed1992

Comparative kill and growth rates determined with cefdinir and cefaclor and with Streptococcus pneumoniae and beta-lactamase-producing Haemophilus influenzae.

The relationship between the growth rate and the kill rate was used to evaluate and to compare the in vitro bactericidal activities of cefdinir, a new oral cephalosporin, and cefaclor against Streptococcus pneumoniae and beta-lactamase-producing strains of Haemophilus influenzae. These frequently encountered pathogens of community-acquired respiratory tract infections are usually susceptible to both drugs. The MIC ranges for cefdinir and cefaclor were, respectively, 0.03 to 0.06 and 0.25 to 0.5 micrograms/ml for S. pneumoniae and 0.25 and 4 to 8 micrograms/ml for H. influenzae. The colony counts (CFU per milliliter) measured after 6 h of exposure to a range of antibiotic concentrations in broth were plotted against the colony count of the control culture over the same period of time. Higher kill rates versus bacterial growth rates were noted for S. pneumoniae for both drugs (positive balance). Conversely, lower kill rates versus growth rates were noted for H. influenzae for both drugs (negative balance). In conclusion, the bactericidal activities of both drugs against S. pneumoniae and H. influenzae were similar when expressed by the relationship between the growth rate and the kill rate at 6 h, but cefdinir was more active at lower concentrations.

Cefaclor↗
PubMed1985

Effect of refrigerated storage on cefaclor in Mueller-Hinton agar.

Cefaclor is less stable than most cephalosporins in media at 35 degrees C. We demonstrated that the activity of cefaclor in Mueller-Hinton agar diminishes continuously at 4 degrees C, resulting in a loss of two-thirds of the activity within 21 days. We recommend that agar dilution plates for this cephalosporin be prepared on the day of their use.

Bacteria↗
PubMed1982

A trial comparing cefaclor with co-trimoxazole in the treatment of acute otitis media.

A prospective random double-blind controlled trial comparing the efficacy of cefaclor with that of co-trimoxazole in the treatment of otitis media was undertaken. Two hundred and twenty-three children aged 12 years or younger were studied. Both drugs were effective, with clinical cure or improvement in more than 90% of the children. The level of compliance was high and side effects few. Both co-trimoxazole and cefaclor can be considered safe and effective drugs for the treatment of acute otitis media.

Cefaclor↗
PubMed1999

Determination of the etiological organism during acute exacerbations of COPD and efficacy of azithromycin, ampicillin-sulbactam, ciprofloxacin and cefaclor. Turkish Thoracic Society COPD Working Group.

Acute exacerbations, most of which are due to lower respiratory tract infections, cause great morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD) and most of these are due to lower respiratory tract infections. The aim of this study was to determine the causative organism and the effects of azithromycin, ampicillin sulbactam (sultamicillin), ciprofloxacin and cefaclor monohydrate therapy in COPD. One hundred and six patients with COPD in acute exacerbation were randomized into four groups for empiric antibiotic treatment following lung function tests and sputum examination. The most common strains isolated from sputum were Haemophilus influenzae (30.8%), Streptoccocus pneumoniae (12%) and Moraxella catarrhalis (7.7%). Azithromycin, sultamicillin, ciprofloxacin and cefaclor monohydrate were found to be effective in treating COPD exacerbations.

Ampicillin↗
PubMed1981

A pharmacological study of cefaclor in the newborn infant.

The absorption and excretion of cefaclor were studied in 10 newborn infants. A mean peak serum concentration of 7.7 microgram/ml was achieved at 1 hour after an oral dose of 7.5 mg/kg. It is concluded that cefaclor is a well absorbed and tolerated cephalosporin for use in newborn infants.

Bacterial Infections↗
PubMed1990

[Effect of cefaclor on guinea pig platelet aggregation in vitro].

Effects of cefaclor (3-chloro-7-D-(2-phenyl-glycinamido)-3-cephem-4-carboxylic acid) on PAF, ADP, collagen, endotoxin, and thrombin-induced platelet aggregation were examined in vitro with the use of guinea pig platelet-rich plasma and washed platelets. PAF, even at concentrations lower than its minimum effective concentration, enhanced ADP- or endotoxin-induced platelet aggregation and prolonged the time to attain the maximum aggregation. PAF also enhanced collagen-induced platelet aggregation and shortened the lag time. Cefaclor (CCL) inhibited the PAF, ADP or thrombin induced platelet aggregation and shortened their maximum aggregation times at higher concentrations such as 300 micrograms/ml or more. CCL also inhibited the collagen-induced platelet aggregation and prolonged the lag time, but showed no effect on endotoxin-induced platelet aggregation. The effect of CCL was almost the same as that of latamoxef (LMOX). CCL and LMOX, however, showed no effect on cellular Ca2+ increase produced by PAF, ADP, or thrombin, suggesting that the inhibitory effect of CCL and LMOX on platelet aggregation is caused by the inhibition of fibrinogen binding to the glycoprotein IIb/IIIa complex.

Adenosine Diphosphate↗
PubMed1985

The effect of cefaclor on the nasopharyngeal flora in children with chronic OME.

About 80% of children with chronic OME carry respiratory pathogens in the nasopharynx, with a remarkably stable spectrum and frequency. In a randomized clinical trial the nasopharyngeal flora was determined in 45 untreated cases and in 32 cases treated with cefaclor (Kefolor), 20 mg/kg body weight b.i.d. for 10 days. Compared to the untreated children, the treated group showed a significantly decreased frequency of Streptococcus pneumoniae and Branhamella catarrhalis, and a reduced number of cultures with mixed pathogens. An approximate quantitative survey showed a decreased growth of Haemophilus influenzae, but the frequency of isolation was unchanged. The results are put in relation to the penetration of cefaclor to adenoid tissue and middle ear effusion in chronic OME.

Bacteria↗
PubMedDate not supplied

Treatment of sinus empyema in adults. A coordinated Nordic multicenter trial of cefixime vs. cefaclor.

In sinus empyema, H. influenzae is the most prevalent pathogen in some subpopulations and in case of therapeutic failure. Cefixime, the first oral cephalosporin of the 3rd generation, is highly potent in vitro against H. influenzae. To study the efficacy and safety of cefixime in adults with acute sinusitis, a coordinated, double-blind multicenter trial was designed for purulent cases, as confirmed by antral aspiration. A total of 364 patients were enrolled in the study with 125 cases randomized to the reference group, assigned to treatment with cefaclor. Evaluation was based on clinical outcome and on antral reaspiration (86% of the cases). No significant differences between the treatment groups were found, as regards short-term or long-term clinical outcome. However, the clinical examination overestimated the therapeutic results. Only 4% of the patients were considered as failures, but the re-aspiration demonstrated remaining suppuration in 14% of all cases (p less than 0.001). Based on re-aspiration, the failure rate among patients with initial growth of pathogens was lower for cefixime (8%) than for cefaclor (20%) (p less than 0.05). Such a difference was not found among patients with growth of H. influenzae. No serious adverse reactions were recorded, but loose stools and diarrhoea were significantly more frequent in the cefixime treatment group. Five patients (2%) in the cefixime treatment group discontinued their treatment due to adverse events.

Cefaclor↗
PubMed1988

Variable in vitro activity of cefaclor, cephalothin and cefadroxil against Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis.

The in vitro activity of cefaclor, cephalothin and cefadroxil to 50 Escherichia coli, 23 Klebsiella pneumoniae and 20 Proteus mirabilis strains was tested with the disc diffusion and microdilution plate techniques. Cefaclor was more active than cefadroxil, while cephalothin was intermediate. The differences seriously affected the classification into the routine SIR system. For susceptibility testing we question the use of cephalothin as a class representative of oral cephalosporins.

Cefaclor↗
PubMed1991

Comparative in vitro activity of cefixime, cefaclor and loracarbef against urinary pathogens.

Minimum inhibitory concentrations of cefixime, cefaclor and loracarbef have been determined against 200 strains of bacteria, representing a wide selection of species causing urinary infections. Cefixime was poorly active against Gram-positive species, but was active (MIC90 less than 2 mg/l) against almost all the Gram-negative pathogens tested (except Pseudomonas aeruginosa), and particularly so against Klebsiella pneumoniae and members of the tribe Proteae. Cefaclor and loracarbef were more active against the Gram-positive species than was cefixime, but had a less broad spectrum against the Gram-negative species. Cefixime use seems more appropriate in nosocomial than in domiciliary urinary infections.

Anti-Infective Agents, Urinary↗
PubMedDate not supplied

A multicenter trial comparing the efficacy and safety of cefuroxime axetil and cefaclor in pneumonia of adults.

The 185 hospitalized patients (aged 19 to 95 years) with pneumonia were randomly assigned to receive 500 mg of cefuroxime axetil orally (250 mg q12h), 1,000 mg of cefuroxime axetil orally (500 mg q12h), or 1,500 mg of cefaclor orally (500 mg q8h), daily, for a mean of nine days. Among the 151 evaluable patients, clinical cure was noted in 58% of the 500-mg cefuroxime axetil group, 94% of the 1,000-mg cefuroxime axetil group, and 88% of the cefaclor group, and clinical improvement in 32%, 4%, and 9%. Bacteriologic outcome was similar in the three groups. Adverse events were minor and comparable among the treatment groups. Cefuroxime axetil is a safe and effective oral antimicrobial for the treatment of pneumonia in adults.

Adult↗
PubMed1988

[Clinical examination of S 6472 (sustained release preparations of cefaclor on chronic respiratory tract infection].

Clinical evaluation of S 6472 (sustained release preparations of cefaclor), a granule form of cefaclor, was performed in 20 patients with chronic respiratory tract infections. The patients subjected to the study consisted of 11 males and 9 females with ages between 44 and 76 years. S 6472 was given orally to each patient in a daily dose of 750 mg in 2 divided portions. The duration of administration was 3 days in 1 case, 7 days in 11 cases, 11 days in 3 cases and 14 days in 5 cases. A total of 5 strains including 2 strains of Staphylococcus aureus, and 1 strain each of Staphylococcus epidermidis, Streptococcus pyogenes and Streptococcus pneumoniae were identified from sputum samples before the administration of the drug. All strains were eradicated but, instead 2 strains, 1 strain each of Enterobacter cloacae and Pseudomonas aeruginosa appeared after the therapy. The clinical efficacy rate was 95.0% (19/20): Excellent in 5 cases, good in 14 cases and fair in 1 case. No side effects were observed, but eosinophilia was observed in 1 case. From the above results, it appeared that S 6472 was effective, safe and useful agent for the treatment of acute exacerbation of chronic respiratory tract infections.

Administration, Oral↗
PubMed1987

Liquid-chromatographic determination of five orally active cephalosporins--cefixime, cefaclor, cefadroxil, cephalexin, and cephradine--in human serum.

We report an isocratic "high-performance" liquid-chromatographic (HPLC) procedure for measurement of five orally administered cephalosporins (cefixime, cefaclor, cefadroxil, cephalexin, and cephradine) in 0.1 mL of human serum. Serum protein is precipitated with acetonitrile, the sample is centrifuged, and the supernate is evaporated under nitrogen. The residue is reconstituted in 0.1 mL of mobile phase, and 50 to 80 microL of this is injected onto a reversed-phase Altex Ultrasphere Octyl (C8) column. The five cephalosporins are resolved by elution with a pH 2.6 mobile phase of methanol/monobasic phosphate buffer (20/80) by vol), flow rate 2 mL/min. The column effluent is monitored at 240 nm. Cefixime serves as the internal standard for the analysis of the four other compounds, cephalexin as the internal standard for cefixime. We used two standard curves for all compounds: a low-range curve for concentrations commonly observed clinically and a higher-range curve for higher concentrations. The former were linear from 1.0 to 10 mg/L for cefaclor, cefadroxil, cephalexin, and cephradine and from 0.1 to 1 mg/L for cefixime. The high-concentration curves were linear from 1 to 10 mg/L for cefixime and from 10 to 100 mg/L for the other compounds. The detection limits were 0.1 mg/L for cefixime, 1 mg/L for the other cephalosporins. Mean within-run and day-to-day CVs were always less than 15% for all compounds studied.

Cefaclor↗
PubMed1985

[Comparative studies of the efficacy, safety and usefulness of S6472, cefaclor and cephalexin on complicated urinary tract infection by the double-blind method].

To objectively evaluated the usefulness of the standard formulation of cefaclor (CCL) and the long-acting formulation of cefaclor (S6472) in noncatheterized complicated urinary tract infection (UTI), a double-blind comparison study was carried out using cephalexin (CEX) as a control. Patients were orally treated with either 500 mg of CCL 3 times/day, 750 mg of S6472 2 times/day, or 500 mg of CEX 4 times/day for 14 days. Overall clinical effect was evaluated on days 5 and 14 in accordance with the UTI therapeutic evaluation standard, with check for recurrence on day 21. There was no demographic difference between the groups. There was no difference in the effective rate on day 5 among the 3 treatment groups: 58.1% in S6472 group, 66.0% in CCL group and 61.9% in CEX group. Nor on day 14, was there any significant difference in the effective rate among the 3 groups: 70.8% in S6472 group, 63.4% in CCL group and 61.8% in CEX group. Stratification analyses (by UTI group, infection site, in- or out-patient, time of starting treatment, pretreatment severity of pyuria, total number of bacteria before treatment) revealed no significant difference among the 3 groups. Therapeutic effect evaluated by physicians in charge was not significantly different among the 3 groups on day 5 or day 14. In terms of overall therapeutic effect, all 3 products were very effective in patients infected with sensitive bacteria: On day 5, 85.4% in S6472 group, 84.4% in CCL group, and 83.7% in CEX group. There was no significant difference among the 3 groups on either day. The incidence of side effects was not significantly different among the 3 groups: 4 out of 129 patients treated with S6472 (3.1%), 2 of 131 treated with CCL (1.5%) and 2 of 128 with CEX (1.6%). Clinical laboratory tests revealed 4 abnormal findings in 4 patients treated with S6472, 6 findings in 4 treated with CCL, and 4 findings in 2 treated with CEX, showing no significant difference in incidence among the 3 groups. Both side effects and abnormal clinical laboratory findings were mild and reversible. Physicians in charge judged the usefulness of the 3 drugs on days 5 and 14, taking efficacy and safety into consideration. Significant difference was not observed. The presence of recurrence was examined 7 days after drug withdrawal in patients regarded as remarkable responders to 14-day treatment by overall therapeutic effect evaluation.(ABSTRACT TRUNCATED AT 400 WORDS)

Administration, Oral↗
PubMed1985

[Fundamental and clinical studies on S6472 (a new prolonged acting preparation of cefaclor) in the urological field].

Fundamental and clinical studies on S6472, a new prolonged acting preparation of cefaclor, were performed and the following results were obtained. Serum level and urinary excretion. 750 mg of S6472, 500 mg of cefaclor (CCL) and 500 mg of cephalexin (CEX) were orally administered in 6 healthy adult volunteers by the cross over method to measure serum level and urinary excretion. The serum level-time curve of S6472 showed 2 peaks at 1 and 6 hours after administration. The peak serum level of S6472 was 4.2 micrograms/ml and 2.9 micrograms/ml, respectively, 1 and 6 hours after administration. The peak serum level of CCL and CEX was 5.8 micrograms/ml and 12.1 micrograms/ml, respectively, 2 hours after administration. The urine level-time curve of S6472 also showed 2 peaks at 0-2 and 4-6 hours after administration and the peak urine level was 1,320 micrograms/ml and 994 micrograms/ml, respectively, 0-2 and 4-6 hours after administration. The peak urine level of CCL was 1,337 micrograms/ml, 0-2 hours after administration and that of CEX was 2,079 micrograms/ml, 2-4 hours. The mean urinary excretion of S6472, CCL and CEX was 56%, 69% and 94% of dose at 12 hours after administration. Clinical evaluation. S6472 was tried in 200 cases of various urinary tract infections. For one group of 85 cases with acute uncomplicated cystitis, clinical effects were evaluated as excellent in 40 cases, moderate in 42 cases and poor in 3 cases, and the overall clinical effectiveness rate was 96.5%. For another group of 68 cases with complicated urinary tract infection, clinical effects were evaluated as excellent in 9 cases, moderate in 27 cases and poor in 32 cases, and the overall clinical effectiveness rate was 52.9%. Side effects. Side effects were observed in 7 cases with diarrhea, epigastralgia, stomatitis, eruption and facial swelling. Administration of S6472 was discontinued in 2 cases, but in 7 cases all symptoms were transient.

Adult↗