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PubMedDate not supplied

Successful treatment with cefaclor of gonococcal urethritis in men.

Cefaclor, a new orally administered cephalosporin, was evaluated by a randomized trial for effectiveness in the treatment of uncomplicated urethritis due to Neisseria gonorrhoeae in men. Regimens included 2,3, and 4 g of cefaclor, with or without 1 g of orally administered probenecid, as single daily doses for three days. The diagnoses were confirmed by isolation of N. gonorrhoeae; cures or therapeutic failures were determined by follow-up cultures on day 7 after completion of therapy. Sixty-six (73%) of 90 treated patients were evaluable for efficacy. The bacteriologic cure rate was 98% (65/66); one patient treated with 2 g of cefaclor plus probenecid had a positive culture for N. gonorrhoeae on follow-up examination. Adverse reactions consisted of mild nausea in five patients (7%) and vomiting in one patient (1%) who received 3- or 4-g doses. No treatment was discontinued, and no abnormality of screening hematologic tests or enzymes was observed. Thus, cefaclor, given in multiple doses, was highly efficacious for treatment of uncomplicated gonococcal urethritis in men.

Cefaclor↗
PubMed1980

Treatment of otitis media with cefaclor, a new oral cephalosporin.

Cefaclor, a new semisynthetic cephalosporin, was evaluated for efficacy in the treatment of otitis media in 46 pediatric patients who had aspiration of the middle ear for culture. The dose of cefaclor ranged from 29 to 42 mg/kg/day administered in three divided doses. No organism was isolated in nine of the 46 patients. Streptococcus pneumoniae was isolated in 43% and Hemophilus influenzae in 27% of the remainder. A bacteriologic cure was achieved in 97% of cases with culturable organisms. The one treatment failure was due to a cefaclor-resistant strain of H influenzae. The medication was well tolerated with the exception of one case of eosinophilia that was possibly drug related. Cefaclor given three times a day is an effective program for the treatment of otitis media.

Acute Disease↗
PubMed1986

Impact of cefaclor on the pharmacokinetics of theophylline.

The influence of cefaclor taken for 8 days (250 mg every 8 h) on the pharmacokinetics of a single intravenous dose of theophylline (2 mg/kg administered on the 8th cefaclor day) was studied in a crossover fashion among 11 healthy adults (10 men and one woman). Theophylline concentrations were measured serially for 12 h by an immunofluorescence polarization technique. No influence of cefaclor was detectable on theophylline clearance, half-life, or volume of distribution. It is concluded that cefaclor and theophylline can be administered together safely.

Adult↗
PubMed1987

Bowel flora changes in humans receiving cefixime (CL 284,635) or cefaclor.

Twelve healthy young male subjects received either cefixime, a new oral cephalosporin (CL 284,635), or cefaclor (six subjects on each drug) orally for 2 weeks. In the case of cefixime, single daily doses of 400 mg were taken; with cefaclor, the dosage was 250 mg three times daily. Modest changes in the fecal flora were noted in both drug groups, but the changes were of different types. In the case of cefixime, there was more of an impact on the indigenous flora, and in the case of cefaclor, there was more ingrowth of new flora. With cefixime, Enterobacteriaceae were usually decreased (the decrease in Escherichia coli count was statistically significant), as were counts of clostridia and sometimes Bifidobacterium spp.; the Bacteroides fragilis group was eliminated in one subject. Coincident with these decreases, four subjects had increases in counts of group D streptococci of 3 logs or more. There was new appearance of Clostridium difficile in four subjects and of Staphylococcus aureus in one; four new strains of Enterobacteriaceae appeared. With cefaclor, there was no decrease of E. coli counts; two subjects had elimination of Bifidobacterium spp. There was little change in counts of group D streptococci. On the other hand, there were 13 new strains of Enterobacteriaceae, two of S. aureus, and three of C. difficile.

Bacteria↗
PubMed1992

Molecular basis of the efficacy of cefaclor against Haemophilus influenzae.

Cefaclor sustained its inhibitory activity against a beta-lactamase-producing strain of Haemophilus influenzae. Although a relatively high permeability coefficient was calculated for ampicillin compared with that calculated for cefaclor, the resulting periplasmic concentration of cefaclor was 5.7 times that of ampicillin. The efficacy of cefaclor may be due to its higher beta-lactamase resistance, which allows it to achieve a greater periplasmic concentration and adequate binding to crucial penicillin-binding proteins.

Anti-Bacterial Agents↗
PubMed1994

Optimal times above MICs of ceftibuten and cefaclor in experimental intra-abdominal infections.

The duration of time that serum drug levels remain above the MIC (time above the MIC) for the pathogen has been shown to be the most significant parameter determining the efficacies of beta-lactam antibiotics. In the described study, we investigated the optimal time above the MIC of ceftibuten and cefaclor using a nonneutropenic mouse model of intra-abdominal infections caused by Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, and Streptococcus pneumoniae. The abilities of the drugs to protect mice against the organisms were determined in mouse protection tests, and the doses were fractionated to produce various dosing regimens with different times above the MIC. All drug-organism combinations showed a significant correlation (r > 0.9) between drug efficacy and the time above the MIC. Also, with ceftibuten treatment, the different dosing regimens that produced equal times above the MIC resulted in the same efficacy, whereas with cefaclor, an apparent dose-dependent effect was observed. These results showed that for a 100% recovery from K. pneumoniae and E. coli infections, the optimal times above the MIC with ceftibuten treatment were 2.2 and 1.6 h, respectively. Relatively high doses of both antibiotics were required to ensure recovery from S. pneumoniae infections. In vitro time-kill studies demonstrated that cefaclor exhibits a marked inoculum effect against the pathogens, and there was a concentration-dependent killing at a large inoculum size. On the other hand, ceftibuten showed no inoculum effect. It is suggested that optimization of both dose and time above the MIC appears to be necessary for the treatment of S. aureus infections with cefaclor, and this may apply to other beta-lactams tht exhibit marked inoculum effects.

Abdomen↗
PubMed2003

Haemophilus influenzae bla(ROB-1) mutations in hypermutagenic deltaampC Escherichia coli conferring resistance to cefotaxime and beta-lactamase inhibitors and increased susceptibility to cefaclor.

The clinical use of cefaclor has been shown to enrich Haemophilus influenzae populations harboring cefaclor-hydrolyzing ROB-1 beta-lactamase. Such a selective process may lead to the increased use of extended-spectrum cephalosporins or beta-lactams plus beta-lactamase inhibitors and, eventually, resistance to these agents, which has not previously been observed in H. influenzae. In order to establish which bla(ROB-1) mutations, if any, could confer resistance to extended-spectrum cephalosporins and/or to beta-lactamase inhibitors, a plasmid harboring bla(ROB-1) was transformed into hypermutagenic strain Escherichia coli GB20 (DeltaampC mutS::Tn10), and this construct was used in place of H. influenzae bla(ROB-1). Strain GB20 with the cloned gene was submitted to serial passages in tubes containing broth with increasing concentrations of selected beta-lactams (cefotaxime or amoxicillin-clavulanate). Different mutations in the bla(ROB-1) gene were obtained during the passages in the presence of the different concentrations of the selective agents. Mutants resistant to extended-spectrum cephalosporins harbored either the Leu169-->Ser169 or the Arg164-->Trp164 substitution or the double amino acid change Arg164-->Trp164 and Ala237-->Thr237. ROB-1 mutants that were resistant to beta-lactams plus beta-lactamase inhibitors and that harbored the Arg244-->Cys244 or the Ser130-->Gly130 replacement were also obtained. The cefaclor-hydrolyzing efficiencies of the ROB-1 variants were strongly decreased in all mutants, suggesting that if bla(ROB-1) mutants were selected by cefaclor, this drug would prevent the further evolution of this beta-lactamase toward molecular forms able to resist extended-spectrum cephalosporins or beta-lactamase inhibitors.

Amoxicillin-Potassium Clavulanate Combination↗
PubMed1982

Biliary excretion of cefaclor. Experimental and clinical study.

Biliary excretion of cefaclor, a new orally active cephalosporin, was studied in vitro using an isolated rabbit liver preparation perfused for 3 h (n = 5). Under these conditions, bile recovery amounted to 2.3% of the cefaclor dose added to the circulating blood (10 mg). In humans, after oral administration of a 1-gram dose of cefaclor to cholecystectomized patients provided with a T tube (n = 10), a mean biliary peak concentration of 7.6 +/- 2.4 microgram/ml was observed at the 3rd hour. Cumulative biliary excretion amounted to 0.05% of the administered dose. Assays performed on samples collected during cholecystectomy in 10 patients 1 h after intake of a 1-gram dose of cefaclor showed mean concentrations of 13.7 +- 1.2 micrograms/ml in serum, 8.1 +/- 1.3 micrograms/ml in common duct bile and 5.9 +/- 1.4 micrograms/ml in gallbladder bile. These results were compared with the data obtained after administration of seven other cephalosporins studied under identical conditions.

Adult↗
PubMed1989

Antimicrobial activities and susceptibility testing considerations of ampicillin, cephalothin, cefaclor, and cefuroxime against invasive isolates of Haemophilus influenzae.

The activities of ampicillin, cefaclor, cephalothin, and cefuroxime against invasive clinical isolates of Haemophilus infleunzae were studied to determine the correlation between resistance and beta-lactamase production. Approaches to in vitro susceptibility testing of cephalosporins in the clinical laboratory were also assessed. Three hundred and eight isolates of H. influenzae were tested for ampicillin susceptibility, and those which required for inhibition greater than or equal to 1.0 micrograms/ml of ampicillin were tested for beta-lactamase production with a chromogenic cephalosporin. Twenty-two percent of isolates produced beta-lactamase and 85% were serotype b. All isolates considered resistant (MIC greater than or equal to 2.0 micrograms/ml) to ampicillin produced beta-lactamase. A single beta-lactamase-producing isolate was identified, but was inhibited by 1.0 microgram/ml of ampicillin, and a zone diameter of 20 mm was produced by disk diffusion testing. One hundred and ninety-seven isolates were tested for susceptibility to cefaclor, cefuroxime, and cephalothin. Chloramphenicol susceptibility testing by disk diffusion was also performed on these isolates. General agreement and interchangeable results were found among these three cephalosporins by both agar dilution and disk diffusion methods. We conclude that ampicillin-resistant H. influenzae not producing beta-lactamase is rare among these isolates of H. influenzae responsible for invasive disease. Susceptibility testing results of cephalothin, cefaclor, or cefuroxime appear to be interchangeable, although results of cephalothin testing would tend to underestimate the activities of cefaclor or cefuroxime.

Ampicillin↗
PubMed1983

Decreased absorption of cefaclor in short bowel syndrome.

Oral cefaclor is rapidly absorbed in patients with a shortened gastrointestinal tract (23 cm). A case is reported of a 27-month-old female child who had received oral cefaclor for five days in treatment of otitis media. The child had had a bowel resection at birth. She did not respond to oral therapy with cefaclor and was admitted to the hospital, where she received cefamandole intramuscularly. The patient recovered in five days. Further investigation using cefaclor with this patient demonstrated serum concentrations below the minimum inhibitory concentration of Hemophilus influenzae, pneumococcus, and many other organisms. When oral antibiotics are prescribed, it is necessary to monitor serum concentrations to ensure absorption.

Cefaclor↗
PubMedDate not supplied

Clinical and pro-host effects of cefaclor in prophylaxis of recurrent otitis media in HIV-infected children.

The aim of this study was to evaluate the efficacy of cefaclor in the prophylaxis of recurrent acute otitis media (AOM) in human immunodeficiency virus (HIV)-infected children. The study was carried out in children born between 1 January 1986 and 31 December 1996 who had been vertically HIV infected Patients who had experienced recurrent AOM between October 1997 and March 1998 (period 1) were eligible for the trial. Recurrent AOM was defined as the occurrence in the same patient of three or more episodes of AOM within 6 months of the observation period. Patients recruited for this trial received cefaclor at a dose of 20 mg/kg once daily for 6 months between April and September 1998 (period 2). Clinical observation was carried out in periods 1 and 2 and for the first 6 months after prophylaxis, i.e. October 1998 - March 1999 (period 3). Natural killer-cell activity, phagocytosis and myeloperoxidase activity were determined before and at the end of the prophylactic period. For each period, CD4-cell count measurement and CD4-positive cell class were recorded. Seventeen children were recruited for this trial. No significant differences were observed in natural killer-cell activity between periods 1 and 2, nor were any significant differences observed in CD4-positive cell class or CD4-positive cell count between the three periods. However, cefaclor administration was associated with a reduction in the number of AOM episodes in 100% of cases and a mean increase in myeloperoxidase activity in 57% of cases. This suggests that cefaclor may be useful in the prophylaxis of recurrent AOM in HIV-infected children.

Acute Disease↗
PubMed2001

Desirable and undesirable immunotropic effects of antibiotics: immunomodulating properties of cefaclor.

The effect exerted on complex immunoregulatory functions of the immune system is an important criterion when selecting an antibiotic. When assessing the effect of an antibiotic on the immune system, one should also take into consideration the existence of functional relationships between the immune system and the nervous and hormonal systems. Among these three systems, there are common factors that modify biological processes. This makes it possible for the antibiotic not only to interact directly with the elements of the immune system, but also to exert indirect influences on potential neurotropic and endocrinotropic effects of the drug. Besides highly effective bactericidal activity, cefaclor demonstrates the ability to exert a favorable effect on some of the specific and non-specific immune responses and immunoregulation mechanisms, which may be important from a clinical point of view. Cefaclor enhances phagocytosis and bactericidal activity of granulocytes and macrophages, and favorably modifies the cooperation of monocytes and T lymphocytes. In this way, it corrects, both in vivo and in vitro, the immunoregulatory disturbances induced and aggravated by an infection. This effect is reflected by an improvement in the impaired immunoregulating activity of T lymphocytes, and is manifest both as an increase in suppressive activity and a correction of the monokine level ratio in relation to the decrease of proinflammatory monokine IL-1 and a relative increase of antiinflammatory IL-1ra. By normalizing the disturbed immunoregulation mechanism, cefaclor enhances the protective potential of the immune reaction while it also reduces the risk of immunogenic clinical complications such as persistent inflammatory conditions and allergic and/or autoaggressive responses. Such immunomodulating properties of cefaclor may be useful in the clinical treatment of patients with immune disorders leading to chronic inflammation and secondary allergic or autoaggressive reactions.

Adjuvants, Immunologic↗
PubMed1994

Cefetamet pivoxil vs cefaclor in the treatment of acute otitis media in children.

74 children with acute otitis media (AOM) were entered into an observer-blind randomised multicentre general practice study to compare the efficacy and safety of the new third generation oral cephalosporin, cefetamet pivoxil, at a dose of 10 mg/kg twice daily with the efficacy and safety of cefaclor 10 mg/kg twice daily administered for 10 days. Of 36 evaluable patients in the cefaclor treatment group, 28 (78%) were cured, and a further 4 were improved, giving an overall efficacy rate (cure/improvement) of 89%. Of 36 evaluable patients in the cefetamet pivoxil treatment group, 31 (86%) were cured, and a further 4 were improved, giving an overall efficacy rate of 97%. Adverse events were reported in 4 patients: 1 cefaclor recipient and 3 patients in the cefetamet pivoxil treatment group. Diarrhoea, the most frequently observed adverse event, occurred in both treatment groups. The study results indicate that cefetamet pivoxil and cefaclor appear to have similar efficacy and safety in the treatment of AOM in children.

Acute Disease↗
PubMed1979

Cefaclor in the treatment of uncomplicated gonococcal urethritis.

Cefaclor is a cephalosporin antibiotic whose chemical structure is similar to that of cephalexin. The substitution of a chloro group for the methyl group of cephalexin has produced a compound with markedly improved antibacterial activity, while retaining the property of gastrointestinal absorption. Cefaclor has shown good in vitro activity against Neisseria gonorrhoeae. In a controlled clinical trial, 40 men with uncomplicated gonococcal urethritis received cefaclor given as a one gram loading dose, followed by 500 mg 4 times daily for 3 days, for a total dose of 7 g. All patients were re-evaluated at 3 to 7 days following completion of therapy. Two patients did not complete the entire course of therapy and were eventually treated with another regimen. Of 38 men who took the full course of therapy, 35 were clinically and bacteriologically cured. Two men were clinically infected but had negative pretreatment cultures. Of 19 men with beta-lactamase-positive gonococcal urethritis, 18 were cured, whereas among 17 men with penicillin-sensitive strains, all were cured. There were no adverse reactions to the drug, and all patients expressed a preference for the oral regimen. The success of cefaclor in this pilot study suggests that additional clinical trials should be performed.

Adult↗
PubMed1992

Cefaclor AF: correlation of microbiology and clinical outcome.

Cefaclor is active against Haemophilus influenzae and Moraxella catarrhalis in addition to the pathogens typically susceptible to first-generation cephalosporins. Cefaclor advanced formulation (cefaclor AF) provides the opportunity for once or twice daily dosing of this agent. Clinical trials using cefaclor AF have been carried out in a number of centres on bacterial infections of the respiratory tract, the urinary tract and the skin. In vitro susceptibility tests on selected pathogens from the clinical trials were carried out according to National Committee for Clinical Laboratory Standards recommendations, generally with excellent agreement between in vitro and in vivo response.

Bronchitis↗
PubMedDate not supplied

Cefprozil versus cefaclor in the treatment of acute and uncomplicated urinary tract infections. Cefprozil Multicenter Study Group.

Cefprozil is a new oral cephalosporin with an in vitro spectrum of activity that includes the pathogens most commonly associated with acute and uncomplicated urinary tract infections (UTIs). A multicenter, randomized study was conducted to compare the clinical efficacy and safety of cefprozil, administered once daily, with cefaclor, administered three times a day, for ten days in patients 2 years of age or older who had acute and uncomplicated UTIs. The rate of satisfactory clinical response in evaluable patients was 87% in the cefprozil group and 84% in the cefaclor group. The patient bacteriologic response rates were also similar: 83% for cefprozil and 85% for cefaclor. The overall effective response rate for both cefprozil and cefaclor was 77%. Both drugs were well tolerated, with no difference in the incidence of drug-related adverse events. Because of its efficacy and once-daily dosing regimen, cefprozil may be an alternative to currently available oral antibiotics in the treatment of UTIs.

Acute Disease↗
PubMed1989

[Cefaclor and trimethoprim-sulfamethoxazole for recurrent otitis media].

The efficacy of cefaclor and of trimethoprim-sulfamethoxazole (TMP-SMX) in the management of recurrent otitis media was evaluated in a randomized single-blind controlled trial. The median age of the patients was 12 months (range 5-37); there were 37 boys and 19 girls. All had received 1 or more courses of antibacterials for acute otitis media in the previous 2-3 weeks. 27 were treated with oral cefaclor suspension, 40 mg/kg/day in 3 divided doses, and 29 with 1 mg/kg/day of TMP-SMX (trimethoprim 8 mg, sulfamethoxazole 40 mg) in 2 divided doses, each group for 10 days. 70% of the cefaclor group and 90% of the TMP-SMX group were cured after the 10 days of therapy (0.1 greater than p greater than 0.05). Results were not better on the 21st day as compared with the 10th. Our data indicate a mild preference for TMP-SMX (although p was not less than 0.05), since it needs to be given only twice a day and costs less than cefaclor.

Acute Disease↗
PubMed1985

[The effect of cefaclor, doxycycline and other oral antibiotics on phagocytosis of polymorphonuclear granulocytes and PHA-induced stimulation of blood lymphocytes in man].

The influence of the orally applicable antibacterial agents, cefaclor (Panoral), doxycycline, erythromycin, and cotrimoxazole on phagocytosis by human neutrophil granulocytes was investigated. Further, the influence of cefaclor, erythromycin, and doxycycline on PHA stimulation of human blood lymphocytes was studied. Doxycycline (1 mg/ml) had strongly suppressive effects on phagocytosis, whereas cefaclor (1 mg/ml cotrimoxazole (0.1 mg/ml), and erythromycin (0.1 mg/ml) did not suppress phagocytosis. PHA-induced lymphocyte stimulation was strongly inhibited by doxycycline (10 micrograms/ml), whereas cefaclor (10 micrograms/ml) did not suppress at all. Erythromycin (10 micrograms/ml) exerted some inhibition (average 12.6%). These results are discussed with respect to immunoneutrality of antibacterial agents.

Anti-Bacterial Agents↗