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PubMed1992

An open comparative study of the efficacy and safety of sultamicillin versus cefaclor in the treatment of acute otitis media in children.

In an open study, children (age range 6 months-12 years) with otitis media due to a bacterial infection were treated orally with 50 mg/kg sultamicillin (n = 30) in two equal doses each day for a mean of 10 days, or 40 mg/kg cefaclor (n = 30) in three equal doses each day for a mean of 11 days. Earache was rapidly improved by either treatment; none of the 27 evaluable sultamicillin-treated or the 29 evaluable cefaclor-treated patients had earache after 8-10 days. Other signs and symptoms (reddened eardrums, perforated eardrums, middle ear fluid, hearing loss) gradually improved during treatment. All the pathogens isolated from patients in the sultamicillin treatment group were eradicated, as were all but one of the pathogens isolated from patients in the cefaclor treatment group. In the sultamicillin treatment group 65.4% of patients were cured and 34.6% were improved, and in the cefaclor group 65.5% were cured and 31.0% improved, but there was one treatment failure. Study drug-related adverse events were experienced by 33.3% of sultamicillin- and 40.0% of cefaclor-treated patients, all but one (urticaria in a cefaclor-treated patient) were gastro-intestinal. The dose administered was reduced by approximately 50% in patients experiencing adverse effects. This did not lead to any reduction in efficacy and no patient was withdrawn due to adverse events.

Acute Disease↗
PubMedDate not supplied

Loracarbef (LY163892) versus cefaclor in the treatment of acute bacterial bronchitis.

In this double-blind study, 319 patients (133 men, 186 women) with acute bronchitis were randomly assigned to receive 200 mg of loracarbef twice daily (n = 160; mean age, 42 years) or 250 mg of cefaclor thrice daily (n = 159; mean age, 43 years) for seven days. Clinical and bacteriologic responses were assessed in 63 loracarbef-treated and 56 cefaclor-treated patients in whom pretreatment positive cultures of pathogens susceptible to loracarbef and cefaclor were found. Among these evaluable patients, a clinical cure was found in 68.3% of the loracarbef-treated patients and in 66.1% of the cefaclor-treated patients and improvement in 27.0% and 28.6%, respectively; the pathogen was eliminated in 7.9% and 10.7% and presumed eliminated in 82.5% and 82.1%, respectively. Three in the loracarbef group discontinued treatment because of adverse events, two of which (nausea, nausea/diarrhea/vomiting) were presumably related to the drug. Headache was reported by 9.4% of the 160 patients in the loracarbef group and 6.9% of the 159 patients in the cefaclor group; diarrhea by 5.6% and 6.9%, respectively; and dyspepsia/abdominal pain/gastrointestinal disorders by 5.6% and 4.4%, respectively. It is concluded that both loracarbef and cefaclor are safe and effective in the treatment of acute bacterial bronchitis.

Acute Disease↗
PubMed1979

The pharmacokinetics of the oral cephalosporins cefaclor, cephradine and cephalexin.

The pharmacokinetics of the oral cephalosporins cefaclor, cephradine, and cephalexin were examined following single 500 mg oral doses to fasted, healthy volunteers. Absorption of the three compounds was rapid following a brief lag period and peak serum levels were obtained in 1-1.5 hours. Serum levels of cefaclor tended to be lower than those of cephradine and cephalexin during the 2-5 hour postdosing period and cefaclor was eliminated more rapidly than other cephalosporins from serum. No difference was observed in the overall bioavailability of the three antibiotics based on comparable FD/V values. Urine levels of the three cephalosporins greatly exceeded the minimum inhibitory concentrations of susceptible organisms during 0-6 hours postdosing, but were considerably reduced during the 6-12 hour collection period. Total urinary recovery of antibiotic activity accounted for almost 90 percent of dosed cephradine and cephalexin compared to 55 percent of dosed cefaclor. Lower serum levels and reduced urinary recovery of intact cefaclor are probably due primarily to its chemical instability. The reduced levels of cefaclor may be compensated for therapeutically by its greater in vitro antibacterial activity.

Adolescent↗
PubMed1979

Clinical and laboratory studies with cefaclor: efficacy in skin and soft tissue infections.

Clinically relevant, recent isolates of common Gram-positive pathogens were examined for their in vitro susceptibility to cefaclor. Group A streptococci and pneumococci were uniformly sensitive (MICs 0.06--0.12 micrograms/ml) to both cefaclor and cephalothin. Cefaclor was 5--10-fold less active than cephalothin against group B streptococci. S. aureus strains were uniformly more susceptible to cephalothin than to cefaclor, but among isolates from children, almost all were sensitive to the latter drug. In clinical studies of patients with skin and soft tissue infections, cefaclor proved effective. Over 90% of patients with staphylococcal bullous impetigo, streptococcal and mixed streptococcal-staphylococcal forms of pyoderma were cleared after 7--10 day courses of treatment. In addition, twice-daily therapy, examined more recently, proved as effective in these forms of infection as did the conventional dose schedule. No significant adverse reactions were noted. Cefaclor appears to be an effective orally absorbed cephalosporin for common skin and soft tissue infections.

Adolescent↗
PubMed1995

Clarithromycin versus cefaclor in lower respiratory tract infections. The Canadian Bronchitis Study Group.

A randomized study was done to compare the efficacy of clarithromycin 250 mg or 500 mg b.i.d., vs. cefaclor 250 mg or 500 mg t.i.d. for 7-14 d in 197 evaluable patients with lower respiratory tract infection. Ninety-five patients received clarithromycin, 88 with acute bronchitis or exacerbation of chronic bronchitis, and 7 with pneumonia. One hundred and two patients received cefaclor, 86 with bronchitis and 16 with pneumonia. Ten patients (10.5%) in the clarithromycin group did not complete the trial, 5 (5.3%) because of adverse event, and 3 (3.2%) because of clinical failure. Similarly, 11 patients (10.8%) did not complete cefaclor, 2 (2%) because of adverse event, and 7 (6.9%) because of clinical failure. Clinical cure or improvement was observed in 90 (94.7%) of patients on clarithromycin vs. 92 (90.2%) on cefaclor, p = 0.66. Bacteriologic cure was seen in 26/36 patients (72.2%) on clarithromycin vs. 28/40 patients (70%) on cefaclor, p = 0.28. Clarithromycin is just as effective as cefaclor for lower respiratory tract infections and is well tolerated.

Bronchitis↗
PubMed1995

Outcome-oriented managed care comparing efficacies of cefaclor and amoxicillin in acute and recurrent acute otitis media.

A study utilizing outcome-oriented cure is employed to show the effectiveness of a given medical treatment. A specific patient population is studied in order to determine the most effective treatment for a common clinical disorder. A total of 201 children were retrospectively studied to evaluate the efficacy and side effects of amoxicillin and cefaclor in the treatment of acute otitis media and recurrent acute otitis media. There were 456 episodes of acute otitis media; 245 episodes were treated with amoxicillin with an efficacy of 91%, while 211 episodes were treated with cefaclor with an efficacy of 97%. The dosage of 40 mg/kg/day, divided in three equal doses, was employed for both antibiotics in the treatment of acute otitis media, while half of this amount was given once daily for the chemoprophylaxis of recurrent acute otitis media. In the 87 courses of chemoprophylaxis with cefaclor for recurrent otitis media, the efficacy was found to be 53%; while amoxicillin was found to be effective in 30% of the 33 patients studied. There were fewer side effects noted in the cefaclor group than in the amoxicillin group (4% vs. 12%). Both drugs caused diarrhea, while cefaclor also caused a mild maculopapular rash in two patients (1.67%). While amoxicillin remains the drug of choice for acute otitis media (AOM), this study suggests that cefaclor may be a better selection in the chemoprophylaxis of recurrent acute otitis media.

Acute Disease↗
PubMed1998

[Comparison of azithromycin, amoxicillin/clavulanic acid and cefaclor in the treatment of acute ENT infections].

A comparison was made of the clinical effectiveness of azithromycin (once daily for three days at a dose of 10 mg/kg in children or 500 mg/day in adults) and amoxicillin/clavulanic acid and cefaclor (standard doses for 7 to 14 days) in acute ear, nose and throat infections in an open randomized study. The group with azithromycin included 37 otitis media, 24 pharyngotonsillitis and 6 maxillary sinusitis (n = 67). The amoxicillin/clavulanic acid group, 22 otitis media, 19 pharyngotonsillitis and 6 maxillary sinusitis (n = 47) and the cefaclor group, 15 otitis media, 12 pharyngotonsillitis and 4 maxillary sinusitis (n = 31). Fifteen days after beginning treatment, 97% (65/67) of the patients who received azithromycin had improved or cured, compared with 85% (40/47) of those who received amoxicillin/clavulanic acid and 84% (26/31), cefaclor (p < 0.02). Pathogens were not eradicated in 3% (2/58) of the patients who received azithromycin, compared with 13% (4/28) who received amoxicillin/clavulanic acid and 15% (4/28) cefaclor. Patients with azithromycin showed an earlier clinical improvement and more rapid normalization of the leukocyte count, erythrocyte sedimentation rate and acute phase proteins. No patient with azithromycin had adverse effects, versus 15% (7/47) for patients with amoxicillin/clavulanic acid and 16% (5/31) for cefaclor. Treatment compliance was 100, 83 (39/47) and 84% (26/31), respectively (p < 0.01). We conclude that azithromycin treatment for three days is faster and more effective clinically and analytically than standard treatment with amoxicillin/clavulanic acid or cefaclor in acute infections of the ear, nose and throat.

Acute Disease↗
PubMed1977

Comparison of in vitro antibacterial activity of three oral cephalosporins: cefaclor, cephalexin, and cephradine.

Cefaclor, a new oral cephalosporin, was compared in vitro with cephalexin and cephradine against 233 organisms. Evaluations were performed in Mueller-Hinton and nutrient broth and agar using two inoculum sizes. In agar, cefaclor had greater antibacterial activity than either cephalexin or cephradine against isolates of Escherichia coli, Proteus mirabilis, Staphylococcus aureus, Klebsiella pneumoniae, and Salmonella typhi. All three drugs were relatively inactive against isolates of enterococci, Enterobacter species, and indole-positive Proteus. Cefaclor, however, did exhibit the greatest activity of the three antibiotics against these organisms. Although there was wide variability with respect to test parameters, the broth results generally paralleled the agar results. In nutrient broth a clear separation of the results with these three cephalosporins was seen with K. pneumoniae, E. coli, and S. typhi. Cefaclor was the most active, cephalexin had intermediate activity, and cephradine was the least active. From the data obtained in this in vitro study, it can be concluded that cefaclor, which has a substituted chloro group attached to the molecule, had increased antibacterial activity over cephalexin and cephradine. Comparative clinical trials with cefaclor will determine whether the differences outlined above are of clinical significance.

Cephalexin↗
PubMed1978

In vitro susceptibility of Haemophilus influenzae to sulfamethoxazole-trimethoprim and cefaclor, cephalexin, and cephradine.

Sulfamethoxazole-trimethoprim and three oral cephalosporins, cefaclor, cephalexin, and cephradine, were evaluated in vitro as possible alternatives to chloramphenicol in the treatment of non-central nervous system infections due to ampicillin-resistant Haemophilus influenzae. Sixty-four isolates of H. influenzae, including 31 beta-lactamase-positive strains, were tested by the agar dilution method. All strains were inhibited by 0.78/0.039 mug sulfamethoxazole-trimethoprim per ml and by 0.78 mug of chloramphenicol per ml. At 6.25 mug/ml, 100, 11, and 3% of all strains were inhibited by cefaclor, cephalexin, and cephradine, respectively. Thus, on the basis of drug concentrations presumably achievable in serum, 100% of strains were susceptible to sulfamethoxazole-trimethoprim, chloramphenicol, and cefaclor. However, a considerable inoculum effect was noted with both beta-lactamase-positive and -negative strains, when tested with sulfamethoxazole-trimethoprim; the minimal inhibitory concentrations of cefaclor were only slightly affected. Also, synergistic effects of sulfamethoxazole-trimethoprim, sulfamethoxazole-erythromycin, and sulfamethoxazole-cefaclor were seen when combinations were tested against both beta-lactamase-positive and -negative strains, as determined by minimal inhibitory concentrations measured by the broth dilution method and by killing curve analyses. These results support further evaluation of these combinations and of cefaclor alone for the treatment of non-central nervous system infections due to H. influenzae.

Cephalosporins↗
PubMedDate not supplied

Swedish Study Group. A randomized multicenter trial to compare the influence of cefaclor and amoxycillin on the colonization resistance of the digestive tract in patients with lower respiratory tract infection.

Eighty-four patients with lower respiratory tract infections participated in a randomised double-blind parallel multicenter trial in order to compare the efficacy of cefaclor and amoxycillin as treatment for lower respiratory tract infections and their ability to influence colonization resistance. Cefaclor was given to 40 patients and amoxycillin to 44 patients perorally in doses of 250 mg t.i.d. for seven days in a double-blind fashion. Sputum, oropharyngeal and intestinal specimens were taken for microbial analysis to isolate the causative pathogen of the lower respiratory tract infection and to follow the microflora changes before, during and after antibiotic treatment. The clinical outcome showed 92.5% cured or improved patients on cefaclor versus 88.4% on amoxycillin. The difference in clinical outcome between the two treatment groups was not statistically significant. Among the pathogenic bacteria isolated, Haemophilus influenzae, Branhamella catarrhalis and Streptococcus pneumoniae dominated. There was no difference between the two treatments with regard to microbiological efficacy. Treatment with cefaclor did not cause any significant impact on the oropharyngeal microflora. Administration of amoxycillin caused a significant reduction of the number of Streptococcus salivarius and Veillonella cocci, while an increase in number of enterobacteria was seen in the oropharyngeal microflora. In the intestinal flora, cefaclor significantly reduced the number of streptococci, staphylococci and anaerobic cocci, while the number of enterococci, enterobacteria, bacteroides and Candida albicans significantly increased. The intestinal microflora was partly influenced by amoxycillin treatment. Thus there was a significant increase in the number of enterobacteria, anaerobic gram-positive rods and bacteroides. In conclusion, none of these agents caused any major disturbances in the colonization resistance in patients with lower respiratory tract infections.

Adolescent↗
PubMed1979

[Resistance of gram-negative bacteria against cefaclor and other antibiotics (author's transl)].

Five hundred and eighty-six strains of eight species of Enterobacteriaceae were tested for their resistance against cefaclor, cefamandole, cephalothin, ampicillin, mezocillin, tetracycline and co-trimoxazole. Cefaclor showed a low rate of resistance against Escherichia coli (1.2%), Klebsiella (2%) and Proteus mirabilis (3.1%), but a high rate of resistance against indole-positive Proteus species (60%) and Serratia (80%). Cefamandole was also effective against cefaclor and ampicillin resistant strains. Multiresistant strains were predominant especially amongst Enterobacter, Serratia and indole-positive Proteus species. Of 266 ampicillin resistant strains, 198 strains (74.4%) proved to be sensitive to cefaclor. Among the orally administered antibiotics cefaclor exhibited the best result with 12.1% resistant strains compared to 14.8% strains resistant to co-trimoxazole and 45.4% resistant to ampicillin.

Cefaclor↗
PubMed1979

[Therapy of bronchitis and bronchopneumonia in adults with cefaclor (author's transl)].

Sixty-two patients with bronchopneumonia or bronchitis were treated with cefaclor. In 42 patients (= 68%), the therapy was clinically successful. Of the patients who did not respond to therapy, cefaclor-resistant bacteria were found in the sputum culture of seven. Of the remaining 13 patients, ten suffered a secondary infection with cefaclor-resistant bacteria, and in three patients the pathogen found before therapy persisted, although sensitive to cefaclor on testing. In seven patients therapy was clinically successful although cefaclor-resistant pathogens were present before the start of therapy. In the entire group of patients investigated no increase of SGOT, SGPT, alkaline phosphatase, bilirubin, urea or creatinine was observed. In two patients alkaline phosphatase and SGOT increased slightly; in three patients SGPT increased slightly. On the other hand, in several patients initially elevated SGOT, SGPT and alkaline phosphatase activity decreased during therapy. Clinical side-effects were seen in two patients. In one patient with known penicillin allergy a pruritic exanthema developed; in the other patient, who had dermatitis herpetiformis, exacerbation of skin efflorescences occurred.

Adult↗
PubMed1989

Comparative activity of cefixime and cefaclor in an in vitro model simulating human pharmacokinetics.

The dependence of the antibacterial activity of the two oral cephalosporins cefixime and cefaclor on pharmacokinetic properties was investigated in an in vitro model using strains of enterobacteria and a streptococcal strain. In the cultures the course of serum concentrations of the respective antibiotic was simulated. The more rapidly attained (1 h) high peak levels (17.5 micrograms/ml) of cefaclor (500 mg dose) in no case showed an advantage over the more slowly reached (3 h) low peak levels (2.5 micrograms/ml) of cefixime (200 mg dose). Cefixime was comparable to cefaclor with respect to its initial killing velocity, whereas it was generally superior with respect to maximum values for reduction of bacterial counts. Due to its long elimination half-life (2.5 h) cefixime prevented regrowth for at least twice as long as cefaclor, which has a short half-life (0.7 h). As a result of its antibacterial activity and pharmacokinetic properties cefixime can be administered less frequently than cefaclor.

Cefaclor↗
PubMedDate not supplied

The effect of four different types of food on the bioavailability of cefaclor.

This randomized, open-label, balanced, five-treatment, five-period, five-sequence, single-dose and crossover pharmacokinetic study assessed the effect of different types of food on the bioavailability of cefaclor in 18 healthy male volunteers. A single dose of cefaclor, 250-mg capsule was administered at five occasions: after overnight fasting, after two vegetarian (high-fat and low-fat) diets and two non-vegetarian (high-fat and low-fat) diets. Serial blood samples were collected upto 8 h post dose. Serum cefaclor concentrations were determined by a validated HPLC method. AUC values were not significantly affected by food intake, but the T(max) was prolonged and C(max) was decreased, depending on the type of meal. The non-vegetarian diets affected the rate of absorption of cefaclor more than the vegetarian diets. The least decrease in C(max) was produced by low-fat vegetarian diet, while the maximum decrease was produced by high-fat non-vegetarian diet. The results of this study indicate that while the rate of absorption of cefaclor is significantly decreased, the extent of absorption and the rate of elimination are not significantly decreased in the presence of food. As compared to high-fat non-vegetarian diet, the time above MIC50 concentration was significantly increased by low-fat vegetarian diet. The implications of these findings for the large vegetarian Indian population are considerable.

Analysis of Variance↗
PubMed2003

Antibiotic prophylaxis by low-dose cefaclor in children with vesicoureteral reflux.

Sulfamethoxazole/trimethoprim (SMX/TMP) and nitrofurantoin are the most frequently used agents for prophylaxis to reduce the risk of recurrent urinary tract infections (UTIs) in children with vesicoureteral reflux (VUR). Nitrofurantoin, however, is not available in Japan and increasing resistance of organisms to SMX/TMP has recently raised doubts about its effectiveness as a prophylactic agent. This study was conducted to investigate whether antibiotic prophylaxis using low-dose cefaclor can effectively reduce the risk of recurrent UTIs. Thirty-nine children (31 male, 8 female) with primary VUR were enrolled. Ages varied from 0.5 to 111 months (mean 10.6 months). A prophylactic dose of 5-10 mg cefaclor per kg per day was given 1-3 times daily depending on the patient's age. Mean duration of prophylactic treatment was 15.5 months. Eleven children (ten male, one female) developed breakthrough UTIs during a total of 606 months treatment (or about one further infection in 55 months). Resistance to cefaclor was noted in three organisms: Enterococcus spp., Morganella spp., and Pseudomonas spp. Evidence of antibacterial activity was present in the morning urine samples from all of seven children tested. Cefaclor was well accepted and tolerated by all subjects. None withdrew from the study because of side effects. These results suggest that cefaclor can be an alternative choice for prophylactic treatment because of its safety, good compliance and low rates of resistant Escherichia coli.

Anti-Bacterial Agents↗
PubMedDate not supplied

Prospective randomized study comparing the efficacy and safety of ciprofloxacin with cefaclor in the treatment of patients with purulent bronchitis.

We compared safety and efficacy of ciprofloxacin and cefaclor in the treatment of patients with purulent bronchitis. Fifty-five patients were randomized prospectively to receive ciprofloxacin with a dose of 500 mg orally twice daily or cefaclor 250 mg over 8 hr for 5 days or longer. Patient groups did not differ with respect to age, duration of illness, severity of infection, or number of other concomitant disease states. A significantly larger number of patients in the ciprofloxacin group had poor health status (39.3% vs 7.4% for the ciprofloxacin and cefaclor groups, respectively, p = 0.02). The response to therapy did not differ between groups. Infection was completely resolved in 71.4% vs 66.7% and markedly improved in 7.1% and 11.1% for the ciprofloxacin and cefaclor groups, respectively. The response to therapy and adverse reaction rate did not differ between groups. Seven patients treated with ciprofloxacin and five patients treated with cefaclor developed adverse reactions. We conclude that ciprofloxacin is a useful agent for the treatment of purulent bronchitis.

Adult↗
PubMedDate not supplied

A randomized double-blind controlled trial of roxithromycin and cefaclor in the treatment of acute lower respiratory tract infections in general practice.

A multicenter, randomized, double-blind, single-dummy placebo-controlled study is being undertaken by the Research Unit of the Royal New Zealand College of General Practitioners to compare the efficacy and tolerance of 150 mg twice daily roxithromycin with 250 mg three times daily cefaclor in the treatment of 250 general practice patients with acute lower respiratory tract infections (LRTIs). Interim analysis of 200 patients reveals no statistically significant differences in the study parameters. Of the patients on roxithromycin and cefaclor, 83% and 67%, respectively, had a moderate or severe illness. Based on efficacy criteria, 96% of roxithromycin recipients and 99% of cefaclor recipients had a satisfactory or improved response. On an intention-to-treat basis, this was reduced to 95% for both treatment groups. Sputum grading and semiquantitative culturing was performed according to NCCLS standards. The most common isolates in order were Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae. Efficacy for bacteriologically evaluable cases was 87.5% for roxithromycin and 57% for cefaclor. Four patients on roxithromycin (3.9%) and 11 patients on cefaclor (11.3%) withdrew because of side effects probably or possibly related to the study treatment. The study is ongoing.

Acute Disease↗
PubMed2004

PK-PD modelling of the effect of cefaclor on four different bacterial strains.

The effect of cefaclor against relevant bacterial strains was studied by employing a combined in vivo pharmacokinetic (PK)-in vitro pharmacodynamic (PD) approach. For this purpose selected isolates of Escherichia coli, Moraxella catarrhalis, Haemophilus influenzae and Streptococcus pneumoniae were exposed in vitro to the interstitial cefaclor profile obtained in vivo in the interstitial space fluid of human tissue after administration of commonly used doses of cefaclor and the change in the number of colony forming units per millilitre (CFU/ml) versus time was monitored. Fitting of the data using a modified E(max)-model resulted in a set of mean pharmacodynamic parameters (k0, k(max), EC50) for each bacterial strain. The parameters derived from these experiments were used in a computer-simulation of the antibacterial effects for different dosing regimens and formulations of cefaclor, notably an immediate (IR) and a modified (MR) release formulation. Dosage regimens were compared using the ratio between the number of bacteria remaining after 24 h of a given treatment (N24h). The results indicate that the number of bacteria of all investigated strains killed per day is equivalent when the same daily dose is administered twice a day with the MR dosage form than when given three times a day with the IR dosage form, in spite of the fact that the MR dosage form has approximately 20% lower bioavailability. Best results were obtained with the three-times a day regimen of the MR formulation. In conclusion, the present in vivo-PK/in vitro-PD simulations of the antimicrobial effects of cefaclor indicate that a twice-daily treatment with a MR formulation may offer a convenient and safe alternative to the conventional tid treatment.

Anti-Bacterial Agents↗