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PubMed1984

Cefaclor v amoxicillin in treatment of acute otitis media.

A randomized clinical trial compared cefaclor and amoxicillin for the treatment of acute otitis media (AOM). Twenty-four (77%) of the 31 examined patients treated with cefaclor and 25 (83%) of the 30 examined patients treated with amoxicillin had resolution of signs and symptoms after completing a ten- to 14-day course of the antibiotic. Patients who had bilateral AOM, serous or mucoid middle ear effusion, Hemophilus influenzae cultured from effusion, or more than five previous otitis media episodes, or who were 3 years of age or younger were more likely to fail treatment. Hemophilus influenzae isolated from effusion were significantly less susceptible to cefaclor than amoxicillin, but none of the 12 treatment failures were caused by antibiotic-resistant infections. Eight (36%) of the 22 patients who recovered after treatment and were reexamined one to three weeks later experienced recurrent AOM. Ear-specific, as well as patient-specific, analyses showed no significant differences between cefaclor and amoxicillin.

Acute Disease↗
PubMed1993

Isolation and structure elucidation of a novel product of the acidic degradation of cefaclor.

The acidic aqueous degradation of cefaclor, an orally administered cephalosporin antibiotic, has been investigated. The most prominent peak in the high-performance liquid chromatography profile of a degraded solution of cefaclor was isolated by preparative high-performance liquid chromatography. Mechanistically, the formation of this degradent from cefaclor involves a condensation of two cefaclor degradation products in which both products have undergone contraction from a six-membered cephem ring to a five-membered thiazole ring, presumably via a common episulfonium ion intermediate.

Cefaclor↗
PubMed1979

[Serum and tissue concentrations after a single dose of cefaclor].

Serum and tissue concentrations of cefaclor were determined a total of 155 and 96 times respectively in 16 volunteers after a single dose of 1 g. At this dosage peak concentrations of 13.5, 14.5 and 13.4 mcg/ml were measured after 60, 90 and 120 minutes respectively. Tissues in which concentrations were measured included cortical bone, spongy bone, muscle, fascia, cutis and subcutis. By measuring blood concentrations of the tissue samples, a division could be made for purposes of calculation into intravascular and extravascular active components. Low amounts of extravascular cefaclor could be established merely in the fascia and in the cutis. The cefaclor concentrations found in spongy bone, muscles and subcutis proved to be determined to a large extent by the intravascular antibiotic. No cefaclor could be detected in cortical bone at the given dosage.

Bacteria↗
PubMed1979

[In vitro activity of cefaclor (author's transl)].

A comparative study was conducted on the in vitro activity of cefaclor and other oral cephalosporins against a large number of freshly isolated clinical strains of gram-negative and gram-positive bacteria. The activity of cefaclor against gram-positive pathogens is very similar to that of cephalexin. The action of cefaclor against Streptococcus pneumoniae is superior. Cefaclor is the most active antibiotic against strains of Haemophilus influenzae, and is also more active than cephalexin and cephradine against non-beta-lactamase producing strains of Escherichia coli, Klebsiella species and Proteus mirabilis.

Bacteria↗
PubMed1979

[The antibacterial efficacy of cefaclor against bacteria resistant to ampicillin, tetracycline and co-trimoxazole (author's transl)].

The antibacterial activity of the new oral cephalosporin cefaclor was investigated using 623 freshly isolated bacterial strains. A high degree of efficacy of cefaclor was noticed against Escherichia coli, Proteus mirabilis and Klebsiella. Nearly all strains which were sensitive to ampicillin, tetracycline and co-trimoxazole were also inhibited by cefaclor. Some of the strains resistant to the three above-mentioned antibiotics were also sensitive to cefaclor as follows: all of ten P. mirabilis strains resistant to co-trimoxazole, 54% of the E. coli strains resistant to ampicillin, tetracycline and co-trimoxazole, and 18% of the Klebsiella strains resistant to tetracycline and co-trimoxazole.

Cefaclor↗
PubMed1979

[Bacteriological in vitro investigations with cefaclor. Correlation of inhibition zone diameter and minimal inhibitory concentration (author's transl)].

A comparison of the minimal inhibitory concentrations (MIC) of cefaclor and cephalexin shows that cefaclor is noticeably superior against Citrobacter. Enterobacter and Proteus mirabilis. Only slight differences are seen against other enterobacteria and Staphylococcus aureus. Both cefaclor and cephalexin are completely ineffective against enterococci and Pseudomonas aeruginosa. Regression analysis to correlate the inhibition zone diameter and MIC of cefaclor produced a very good correlation (r = -0.9741). Using 30 mcg discs on DST agar, inhibition zones of more than 20 mm are to be interpreted as "sensitivity" and zones of less than 13 mm as "resistance".

Bacteria↗
PubMed1979

[Pharmacokinetics of cefaclor and initial therapeutical experience (author's transl)].

Twelve normal volunteers in the fasting state were given 1000 mg cefaclor, and the serum and urine concentrations over 8 h and 24 h respectively were measured. The average peak serum concentration was 34.6 +/- 7.8 mg/l, this value being reached after 65.2 +/- 11.1 min; the half-life was 42.5 +/- 8.3 min. In another six volunteers the absorption of 500 mg of 'cefaclor following administration in the fasting state and after a test breakfast was studied. The peak serum concentrations after administration in the fasting state were 16.1 +/- 3.2 mg/l, and after a meal 12.5 +/- 1.9 mg/l; the areas under the curve did not differ. The low recovery rate of cefaclor in urine observed in this series of investigations could be partly explained by the inactivation of the substance in urine. Cefaclor was administered therapeutically to 23 patients, most of whom were suffering from bronchopulmonary infections and chronic pyelonephritis. The results of therapy were good in four patients, satisfactory in 13 patients and unsatisfactory in three patients. Intolerance was rare.

Cefaclor↗
PubMed1979

Cefaclor in the treatment of susceptible infections in infants and children.

Fifjty-two outpatients, aged from six months to 17 years, and suffering from Group A streptococcal pharyngitis, skin and soft tissue infection, urinary tract infection, or otitis media were enrolled in the study. The dosage of cefaclor was 20 to 40 mg/kg/day in three or four divided doses for ten days. In 43 children given either cefaclor suspension or capsules, plasma level estimations were performed. Cefaclor readily produces therapeutic plasma levels in children. Cefaclor appears to be a safe, well tolerated and effective antimicrobial agent in children. It has a distinct advantage over other antibiotics in children with Haemophilus influenzae otitis media and should be considered as a primary drug in treatment of otitis media.

Adolescent↗
PubMed1983

Cefaclor versus amoxicillin in the treatment of bacterial pneumonia: a comparative double-blind study.

A randomized double-blind controlled trial was carried out to compare the effectiveness and side-effects of cefaclor with those of amoxicillin in the treatment of 34 patients hospitalized because of acute bacterial pulmonary infection. Cefaclor and amoxicillin were given three times daily before meals in a dosage of 500 and 750 mg respectively for seven days. The cure rate was 94% in the group of patients treated with cefaclor and 89% in the group treated with amoxicillin. According to all the parameters used to assess outcome, no significant difference was found between the two antibiotics tested. In this study, cefaclor and amoxicillin appeared to be of equal value in the treatment of bacterial pneumonia or bronchopneumonia.

Adult↗
PubMedDate not supplied

Comparative effect of different types of food on the bioavailability of cefaclor extended release tablet.

This randomized, six-treatment, six-period, six sequence, single dose, crossover pharmacokinetic study assessed the effect of different types of food on the bioavailability of 500-mg cefaclor extended release tablet in 23 healthy male volunteers. A single dose of cefaclor extended release 500-mg tablet was administered at six occasions: after overnight fasting, after two vegetarian (high-fat and low-fat), two non-vegetarian (high-fat and low-fat) and rice diets. Serial blood samples were collected up to 12 h after dose. Serum cefaclor concentrations were determined by a validated HPLC method. An almost equivalent increase in both Cmax and AUC was observed with both high-fat non-vegetarian and low-fat vegetarian breakfasts. However, when MIC90 values, a pharmacodynamic end-point were compared, the low-fat vegetarian diet fared better than the high-fat non-vegetarian diet. The results obtained favor low-fat vegetarian diet (breakfast) to be taken with cefaclor extended release tablet to achieve maximum benefit in terms of clinical efficacy.

Adult↗
PubMed1981

A comparison of cefaclor versus trimethoprim-sulfamethoxazole combination in the treatment of acute urinary infections.

Acute lower urinary tract infections were treated in 57 women according to a randomized protocol, using either cefaclor, a cephalosporin whose chemical structure is similar to that of cephalexin, or trimethoprim-sulfamethoxazole combination. Urine cultures were made before treatment was started, midway through the 10-day course of therapy, 1 week after therapy and 4 to 6 weeks after therapy, if possible. Urine cultures in 100 per cent of the patients became sterile during therapy and remained so 1 week after therapy. Of those patients undergoing followup cultures 4 to 6 weeks after therapy 98 per cent had sterile urine. Twenty-nine patients were randomized to cefaclor therapy and 28 received a trimethoprim-sulfamethoxazole combination. There was no difference between the 2 drugs studied in terms of efficacy. No side effects were noted with cefaclor and 2 minor side effects were noted with the trimethoprim-sulfamethoxazole combination. Cefaclor in a twice daily dosage schedule appears to be a safe and useful drug in the treatment of urinary tract infections caused by the common gram-negative organisms and it appears to be as efficacious as the trimethoprim-sulfamethoxazole combination.

Adolescent↗
PubMedDate not supplied

Clinical comparison of cefaclor twice daily versus amoxicillin-clavulanate or erythromycin three times daily in the treatment of patients with streptococcal pharyngitis.

The present study was undertaken to compare the efficacy and safety of a new regimen of cefaclor (25 mg/kg BID) with amoxicillin-clavulanate and erythromycin TID at standard doses for the treatment of pediatric patients with acute pharyngotonsillitis (APT). A total of 673 children (age range, 2 to 12 years) with signs and symptoms of APT were enrolled; 245 of these children who had a positive throat culture for group A beta-hemolytic streptococci (GABHS) entered the study and were randomly assigned to receive cefaclor 25 mg/kg BID, amoxicillin-clavulanate 15 mg/kg TID, or erythromycin 15 mg/kg TID. A 10-day antibiotic course was prescribed for each patient. Clinical and bacteriologic responses were assessed at the end of treatment (day 10) and at the follow-up visit (day 30). All GABHS strains isolated from throat cultures were tested for in vitro sensitivity to the antibiotics used in the study. Side effects (mainly nausea) were rare and mild in each group and did not require discontinuation of therapy. No GABHS strain was resistant to cefaclor or to amoxicillin-clavulanate; 37.9% of the strains were resistant to erythromycin. The results indicated that cefaclor given BID seems to be as effective as amoxicillin-clavulanate given TID (cure rate, 91.9% and 90.5%, respectively) and more effective than erythromycin given TID (cure rate, 76.8%) for the treatment of patients with APT. Erythromycin resistance among GABHS is an emerging problem in many geographic areas.

Amoxicillin-Potassium Clavulanate Combination↗
PubMed2003

Etiology of acute otitis media in childhood and evaluation of two different protocols of antibiotic therapy: 10 days cefaclor vs. 3 days azitromycin.

BACKGROUND: Acute otitis media (AOM) is a common childhood infection that is frequently treated by antibiotics. There are no prospective and comprehensive trials evaluating childhood AOM for etiologic pathogens and resistance pattern in Turkey. The aims of the study were to determine the bacterial etiologies and resistance patterns, and identify the efficacy and the relapse rates of 3 days of azitromycin and 10 days of cefaclor therapy in AOM. METHODS: This prospective, randomized, single-blind, open study was carried out in 78 cases of AOM. Mean age was 30.7+/-27 months. Tympanocentesis and aspiration of middle ear fluid (MEF) were used to obtain purulent material from the middle ear. Group 1 consisted of the cases (n=41) on azitromycin therapy and Group 2 (n=37) on cefaclor. Dosage of azitromycin was 10 mg/kg per day for 3 days and cefaclor 40 mg/kg per day for 10 days. The patients were evaluated on days 3-5 (second visit), day 10 (third visit), and day 30 (fourth visit) during follow-up. RESULTS: A total of 50 species were isolated from 44 of 78 cases from which materials were obtained (44/78; 56.4%). Most frequently isolated microorganism was Streptococcus pneumoniae (n=18; 36%), followed by Haemophilus influenzae (n=11; 22%), S. aureus (n=9; 18%), Moraxella catarrhalis (n=4; 8%), and group A beta-hemolytic streptococcus (GAS, n=4; 8%). Enterococcus faecalis was isolated from three cases and H. parainfluenzae from one. Penicillin and amoxicillin resistances of bacteria were found to be 40 and 36%, respectively. The frequency of penicillin and amoxicillin resistance in </=24-month age group was 59 and 66.6%, respectively. The patients did not demonstrate significant differences in terms of cure rate on the third to fifth day (Group 1: 32.5%; Group 2: 36.4%), 10th day (Group 1: 76.9%; Group 2: 84.8%), and on 30th day (Group 1: 91.3%; Group 2: 81.8%). There were no significant differences with respect to side effects, relapse, and re-infection rate between the two groups. CONCLUSION: In more than half of the AOM cases, bacteria were isolated from MEF and most frequently isolated organisms were S. pneumoniae, H. influenzae, and S. aureus. Three-day azitromycin therapy was as effective as 10-day cefaclor therapy.

Acute Disease↗
PubMed1996

In vitro susceptibilities of 180 clinical isolates of Haemophilus influenzae to ampicillin, amoxycillin/clavulanate, cefaclor, cefuroxime, cefotaxime, clarithromycin, and azithromycin.

One hundred eighty consecutive, unduplicate isolates of Haemophilus influenzae from clinical specimens collected from November 1994 through February 1995 in nine general hospitals throughout Belgium were examined for beta-lactamase production using a nitrocefin-based test, and for their in vitro susceptibilities to ampicillin, amoxycillin/clavulanate, cefaclor, cefuroxime, cefotaxime, clarithromycin and azithromycin by means of the NCCLS agar dilution test. The isolates were all from respiratory tract specimens. The prevalence of capsular type b was 1.1%, and the overall rate of beta-lactamase production 16.7%. Rates of beta-lactamase production were higher in isolates from children (22.0%) than in those from adults (15.3%), and in isolates from upper respiratory tract specimens (22.0%) than in those from the lower respiratory tract (15.1%). Beta-lactamase-negative ampicillin resistance amounted to 1.1%. Cefotaxime had the highest activity on a weight basis [MIC (minimal inhibitory concentration) for 50% of the isolates tested (MIC50) < or = 0.06 microgram/ml], followed by ampicillin (MIC50 of 0.25 microgram/ml), amoxycillin/clavulanate and cefuroxime (MIC50 of 0.5 microgram/ml), azithromycin (MIC50 of 2 micrograms/ml), cefaclor (MIC50 of 4 micrograms/ml), and clarithromycin (MIC50 of 8 micrograms/ml). Cefotaxime was also the most active drug in terms of susceptibility rates of the isolates (100.0%), followed by amoxycillin/clavulanate and azithromycin (98.9%), cefuroxime (97.2%), cefaclor (89.4%), clarithromycin (82.8%), and ampicillin (82.2%). In conclusion, amoxycillin/clavulanate and cefuroxime retain an excellent activity against H. influenzae, while cefaclor lost some of its activity. The rate of susceptibility to azithromycin was markedly higher than that to clarithromycin; however, its ability to accumulate intracellularly while concentrations in serum and interstitial fluid remain low, should be considered, as it may represent a major drawback to its use in H. influenzae infections.

Adolescent↗
PubMed1985

Reliability of cefaclor, cefazolin, cefamandole, and cephalothin disks to predict susceptibility of Enterobacteriaceae, Staphylococcus species, and Haemophilus influenzae.

Interpretive zone-size standards currently used for cephalothin and cefamandole disk tests also may be applied to tests with disks containing 30 micrograms of cefaclor or cefazolin. Against 627 representative isolates, susceptibility to cefaclor and cefazolin could be predicted by testing cephalothin. However, cefazolin is more active than cephalothin against isolates of Escherichia coli with a TEM beta-lactamase plasmid. The expanded spectrum of cefamandole continues to necessitate separate testing. Against methicillin-resistant staphylococci, cefaclor disks were more reliable than cephalothin or cefamandole, but false-susceptible results were seen with all four disks. For testing Haemophilus influenzae, the cefazolin disks were not reliable; cephalothin or cefaclor disks could predict susceptibility to either drug.

Cefaclor↗
PubMedDate not supplied

A controlled trial of cefaclor versus amoxicillin for treatment of acute otitis media in early infancy.

Optimal antimicrobial therapy of acute otitis media with effusion in early infancy is controversial. We studied the efficacy of cefaclor and amoxicillin in the treatment of 40 nonconsecutive infants less than 3 months of age in a double blind comparative trial. Infants were randomly assigned to receive either oral amoxicillin or cefaclor in a dosage of 40 mg/kg/day divided into 3 doses for 10 days. Clinical responses and adverse drug effects were evaluated at 48 to 72 hours, 5 to 7 days, 2 weeks and 3 weeks. Pathogenic bacteria isolated from ear aspirates in 24 cases included Streptococcus pneumoniae (14), Haemophilus influenzae type b (5), H. influenzae nontypeable (3), Staphylococcus aureus (4), Branhamella sp. (2), and Streptococcus pyogenes (1). Nonpathogenic bacteria isolated in 14 cases included Streptococcus epidermidis, diphtheroids and Streptococcus viridans. Two aspirates were sterile. A satisfactory clinical response was achieved in 15 of 21 cases (71%) treated with amoxicillin and 14 of 19 cases (74%) treated with cefaclor. We conclude that amoxicillin and cefaclor are comparable in efficacy for the therapy of acute otitis media with effusion in early infancy.

Acute Disease↗
PubMed1987

Comparative efficacies of erythromycin-sulfisoxazole and cefaclor in acute otitis media: a double blind randomized trial.

A prospective double blind trial compared the fixed combination of erythromycin-sulfisoxazole (E/S) with cefaclor in the treatment of acute otitis media. One hundred nineteen children in six centers across Canada were studied. Diagnostic tympanocentesis of 134 ears yielded 135 bacterial isolates: Streptococcus pneumoniae (42%); Haemophilus influenzae (21%); Branhamella catarrhalis (10%); Streptococcus pyogenes (5%); and other bacteria (22%). Seventy-seven percent of strains of B. catarrhalis and 14% of strains of H. influenzae were beta-lactamase producers. E/S exhibited greater in vitro activity against H. influenzae and B. catarrhalis. Twenty-three patients had bacteriologically sterile middle ear fluid. The overall clinical outcome at Days 10 and 31 was identical in both treatment groups. Otoscopic findings improved more rapidly in the E/S group than in the cefaclor group at 10 and 31 days (P less than or equal to 0.04). In cases where pre-treatment middle ear fluid was negative on routine bacterial culture, complete cure at 10 days was observed in 75% of patients treated with E/S but only in 14% of those treated with cefaclor (P = 0.02). Side effects were infrequent and comparable between the test drugs. E/S is at least as effective as cefaclor in the management of acute otitis media and may be superior, particularly for cases not yielding bacteria on routine culture.

Acute Disease↗
PubMed1993

Microbiologic and clinical aspects of a trial of once daily cefixime compared with twice daily cefaclor for treatment of acute otitis media in infants and children.

In this randomized, investigator-blinded multicenter study, tympanocentesis for acute otitis media with effusion in 137 ears from 108 children, 6 months to 12 years of age, revealed 84 definite pathogens and 32 potential pathogens. Twenty-nine aspirates from 23 subjects were sterile. Of the 116 isolates 42 (36%) were Streptococcus pneumoniae, 24 (21%) were Haemophilus influenzae, 9 (8%) were Moraxella catarrhalis, 9 (8%) were Streptococcus pyogenes and 1 (1%) was Staphylococcus aureus. Twenty-two (19%) definite pathogens produced beta-lactamase. Patients were randomized to cefixime (8 mg/kg/day daily) or cefaclor (40 mg/kg/day divided into two doses). Efficacy was determined by pneumatic otoscopy and tympanometry at the end of therapy visit on Days 11 to 14 and up to 4 weeks of follow-up. At end of therapy subjects with definite pathogens exhibited a satisfactory clinical outcome in 26 of 36 (72%) ears for cefaclor and 40 of 48 (83%) ears for cefixime recipients (P = 0.12). For ears with beta-lactamase-producing isolates there were no (0 to 12) cefixime failures but 4 of 10 cefaclor failures (P = 0.03). Diarrhea/loose stools were more frequent in cefixime (16 of 58) than cefaclor (4 of 50) recipients. One cefixime subject required discontinuation of drug. Overall efficacy for treatment of acute otitis media with effusion was not different; however, cefixime appeared more effective for infections caused by beta-lactamase-producing organisms.

Acute Disease↗