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PubMed2004

Reassessment of the cefaclor breakpoint for Streptococcus pneumoniae.

Discrepancies between proven clinical success of cefaclor and its relatively poor activity in vitro were investigated against eight pneumococcal isolates. The bacteriostatic minimum inhibitory concentration (MIC) (the concentration resulting in no growth/kill relative to the starting inoculum) was derived from time kill studies. Bioassay results demonstrated an in vitro half-life of >24 and 9 h for cefuroxime and cefaclor, respectively. The mean NCCLS MIC for cefaclor was 1.4 and 0.3 mg/l for cefuroxime. The corresponding mean bacteriostatic MICs were 0.24 and 0.16 mg/l. Whilst cefaclor NCCLS MICs were significantly higher compared with cefuroxime MICs (P = 0.00058) there was no statistical differences between the bacteriostatic MICs (P = 0.259). Bacteriostatic MIC determination established that cefaclor and cefuroxime are equally active against pneumococci.

Anti-Bacterial Agents↗
PubMed1984

A randomized controlled trial of cefaclor compared with trimethoprim-sulfamethoxazole for treatment of acute otitis media.

We performed a randomized controlled trial of cefaclor administered twice daily compared with trimethoprim-sulfamethoxazole (TMP-SMZ) administered twice daily for the treatment of acute otitis media. Pathogens were eradicated from the middle ear exudate after 3 to 6 days of therapy in 35 of 37 (95%) patients given TMP-SMZ compared with 28 of 40 (70%) given cefaclor (P = 0.017). Haemophilus influenzae was eliminated in 13 of 14 (93%) patients given TMP-SMZ compared with 10 of 18 (56%) given cefaclor (P = 0.047). Clinical outcomes failed to distinguish between patients given TMP-SMZ or cefaclor. Symptoms improved despite persistent infection in 11 of 13 (85%) patients; middle-ear effusion persisted after therapy in 38 of 61 (62%) patients despite eradication of pathogens. We conclude that twice daily TMP-SMZ is more efficacious than twice daily cefaclor for the treatment of acute otitis media and that clinical outcomes may fail to detect differences between antibacterial agents in comparative drug trials in acute otitis media.

Acute Disease↗
PubMed1999

Indirect polarographic and cathodic stripping voltammetric determination of cefaclor as an alkaline degradation product.

Cefaclor is not reducible at a mercury electrode, but it can be determined polarographically and by cathodic stripping voltammetry as its initial alkaline degradation product which is obtained in high yield by hydrolysis of cefaclor in Britton-Robinson (B-R) buffer pH 10 at 50 degrees C for 30 min (reduction peak at pH 10, -0.70 V). Differential pulse polarographic calibration graphs are linear up to at least 1 x 10(-4) mol/l(-1). Recoveries of 93% of the cefaclor (n = 3) were obtained from urine spiked with 38.6 microg/ml(-1) using this polarographic method with 1 ml urine made up to 10 ml with pH 10 buffer. Using cathodic stripping voltammetry and accumulating at a hanging mercury drop electrode at - 0.2 V for 30 s, linear calibration graphs were obtained from 0.35 to 40 microg/ml(-1) cefaclor in B-R buffer pH 10. A relative standard deviation of 4.2% (eta = 5) was obtained, and the limit of detection was calculated to be 2.9 ng/ml(-1). Direct determination of cefaclor in human urine (1 ml of urine was made up to 10 ml with pH 10 buffer) spiked to 0.39 microg/ml(-1) was made (recovery 98.6%).

Cefaclor↗
PubMed2002

Comparative efficacy and safety of 5-day cefaclor and 10-day amoxycillin treatment of group A streptococcal pharyngitis in children.

A total of 384 children with group A beta-haemolytic streptococcal (GABHS) pharyngitis were randomized to receive either 40 mg/kg/day of cefaclor in two doses for 5 days (192 patients), or 40 mg/kg/day of amoxycillin in three doses for 10 days (192 patients). The signs and symptoms of pharyngitis were recorded and throat cultures were obtained at presentation and on days 6-7, 11-15, 16-20 and 28-35. Patient compliance was significantly higher in the children treated with cefaclor (100 vs. 95.1%; P = 0.003). At the end of follow-up, the percentage of clinical success was 91.4% for cefaclor and 91.9% for amoxycillin (P = 0.974); bacteriological success was obtained in 85.7 and 89.6% children (P = 0.348), respectively. Both treatments were well-tolerated with adverse event rates of 8.3% in the cefaclor group and 9.4% in the amoxcillin group (P = 0.857). Our study shows that five days' treatment with cefaclor is as effective and safe as the conventional 10-day course of amoxycillin in the treatment of GABHS pharyngitis, but compliance seems to be significantly greater.

Amoxicillin↗
PubMed1991

Cefaclor in the treatment of infective exacerbations of chronic bronchitis in cigarette smokers.

There is a direct correlation between number of cigarettes smoked and the incidence of lower respiratory tract infection in humans. In studies with smokers suffering from exacerbations of chronic bronchitis, the most common bacterial pathogens found were Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus aureus and Branhamella catarrhalis. Antibiotics should be effective against such possible pathogens. Cefaclor has demonstrated in vitro activity against all these pathogens. We designed the present study to evaluate the efficacy and safety of cefaclor in the treatment of acute exacerbations of chronic bronchitis in cigarette smokers. A total of 106 patients were enrolled in the study. H. influenzae was the most common bacterial species isolated in the sputum (in 23.6% of the total sample), followed by S. pneumoniae (18.9%), S. aureus (17.0%), K. pneumoniae (7.5%) and B. catarrhalis (5.7%), while mixed forms were present in 22.6% of cases and other pathogens in 4.7%. Cefaclor (500 mg) was given orally every 8h for 7 to 16 days (mean 10.73 +/- 2.11). Analysis of clinical response data indicates that 75.5% of patients were cured and 17.0% improved. This finding is important because it demonstrates that cefaclor's spectrum of activity encompasses all the most likely pathogens encountered in smokers. Because of its excellent response rate, cefaclor is of particular value in the treatment of lower respiratory tract infections in cigarette smokers.

Adult↗
PubMed1993

Comparison of the efficacy and safety of ceftibuten and cefaclor in the treatment of pneumonia and bronchiectasis.

In a multicentre, international study of 187 adult patients with bacterial pneumonia or bronchiectasis, the safety and efficacy of a regimen of 200 mg ceftibuten administered twice-daily was compared with cefaclor given in a dosage of 500 mg three times a day. Of the 94 evaluable patients, 66 received ceftibuten and 28 received cefaclor. The overall bacteriological response was similar in the two treatment groups with elimination of the original pathogen in 91% and 89% of the patients receiving ceftibuten and cefaclor, respectively. The overall clinical response mirrored the bacteriological results with a successful clinical outcome in 92% of ceftibuten-treated patients compared with 93% in patients receiving cefaclor. Adverse experiences were, in general, few and mild, being reported in 8% and 17% of patients receiving ceftibuten and cefaclor, respectively.

Adolescent↗
PubMed1988

In-vitro activity of cefaclor, cephalexin and ampicillin against 2458 clinical isolates of Haemophilus influenzae.

The zone sizes and MICs of ampicillin, cefaclor and cephalexin were determined for 2458 clinical isolates of Haemophilus influenzae collected in 1986 during a national survey of the prevalence of resistance in this species. Cefaclor showed greater in-vitro activity than cephalexin against all isolates, with a modal MIC of 4 mg/l compared with 8 mg/l. MIC50 values for the 2201 ampicillin-sensitive and 157 beta-lactamase-positive resistant strains were similar for both cephalosporins (4 mg/l for cefaclor, and 8 mg/l for cephalexin). A further 100 strains with a reduced zone (less than 20 mm) to a 2 micrograms ampicillin disc showed a definite (MIC greater than or equal to 4 mg/l) or intermediate (MIC 1 or 2 mg/l) degree of intrinsic resistance to ampicillin. Both cephalosporins showed a marked and significant rise in MIC values for this group. Cefaclor is the more active agent against ampicillin-sensitive and beta-lactamase-positive H. influenzae but strains with an intrinsic mechanism of resistance to ampicillin are markedly less sensitive to both cefaclor and cephalexin.

Ampicillin↗
PubMed1990

Comparison of cefpodoxime proxetil with cefaclor in the treatment of sinusitis.

The efficacy and tolerance of cefpodoxime proxetil were compared with those of cefaclor in a multicentre, international, prospective, double-blind, placebo-controlled study in adult outpatients suffering from acute sinusitis. At the end of treatment, cefpodoxime proxetil was more effective than cefaclor, producing complete clinical cure in 84% of cases (102/122) vs 68% of cases (77/114) in the cefaclor group (P = 0.01). The overall clinical efficacy (cure + improvement) was similar in the two groups with 95% (116/122) satisfactory responses in the cefpodoxime proxetil group and 93% (106/114) in the cefaclor group. Bacteriological response was similar with 95% eradication in the cefpodoxime proxetil group (55/58) vs 91% with cefaclor (63/69).

Acute Disease↗
PubMed1991

Ceftibuten versus cefaclor for the treatment of bronchitis.

Ceftibuten is an oral third generation cephalosporin with potent antimicrobial activity against Enterobacteriaceae, beta-lactamase positive Haemophilus influenzae, Moraxella catarrhalis, Neisseria meningitidis, Neisseria gonorrheae, penicillin-susceptible pneumococci, and beta-hemolytic streptococci. To study the efficacy and safety of ceftibuten for treatment of bronchitis, 58 patients were randomized to therapy with either ceftibuten 400 mg once a day or cefaclor 250 mg every 8 h at a ratio of two to one. Of 45 clinically evaluable patients, 28 (87.5%) of the 32 ceftibuten patients and 12 (92.3%) of the 13 cefaclor patients were clinically improved or cured. Of 33 microbiologically evaluable patients, 21 (87.5%) of the 24 ceftibuten patients and eight (80%) of the ten cefaclor patients were cured. Of 56 patients evaluable for adverse effects, three (7.9%) of the 38 ceftibuten patients and one (5.6%) of the 18 cefaclor patients had adverse reactions. In this small study, once-daily ceftibuten appeared as safe and as effective as cefaclor for the treatment of bronchitis.

Bacteria↗
PubMedDate not supplied

Duration of effusion after antibiotic treatment for acute otitis media: comparison of cefaclor and amoxicillin.

A double-blind randomized clinical trial was conducted at two sites comparing cefaclor and amoxicillin for the treatment of acute otitis media with effusion in 214 children (293 ears). Each child underwent unilateral or bilateral tympanocentesis and then was randomly assigned to receive a 14-day course of either amoxicillin or cefaclor. The symptomatic clinical response was the same for the two antibiotics, with four children considered "treatment failures" in each antibiotic treatment group. By 14 days after entry into the study 59 of 106 children (55.7%) in the cefaclor group had ears that were effusion-free as compared to 40 of 97 children (41.2%) in the amoxicillin group (P = 0.05). When considering all children with effusion-free ears as well as those "improved" from their original status (those with bilateral middle ear effusions at entry but only unilateral after treatment), 68 of 106 children (64.2%) receiving cefaclor were effusion-free or "improved," compared to 43 of 97 children (44.3%) receiving amoxicillin (P = 0.01). However, by 42 days after entry the percentage of children whose ears were without effusion or "improved" was equal in both treatment groups (68.9% in the cefaclor group and 67.5% in the amoxicillin group). The reasons for the differences observed at 14 days after entry are not readily apparent.

Acoustic Impedance Tests↗
PubMedDate not supplied

Comparison of cefaclor and trimethoprim-sulfamethoxazole in the treatment of acute otitis media.

The efficacy and safety of cefaclor and trimethoprim-sulfamethoxazole (TMP-SMX) were compared in 100 children with acute otitis media assigned to the two treatment groups in a double-blind, randomized fashion. Treatment was for 10 days. Each patient had a diagnostic tympanocentesis before starting therapy. Pathogens were isolated from the middle ear aspirate in 49% of the cases, and organisms considered nonpathogenic were isolated as pure cultures from an additional 19%. Of the 100 patients 4 of 50 in the cefaclor group and 2 of 50 in the TMP-SMX group were considered treatment failures. In three of the four failures with cefaclor, compliance with the first course of therapy could not be ascertained. All six patients showed a good therapeutic response to an additional 10-day course of cefaclor. We conclude that cefaclor and TMP-SMX have essentially equivalent efficacy in the treatment of acute otitis media.

Acute Disease↗
PubMedDate not supplied

Quantitative comparison of adverse reactions to cefaclor vs. amoxicillin in a surveillance study.

During an 18-month adverse events surveillance period, children with a history of recurrent suspected or proved bacterial infections were treated with either cefaclor (1017 patients, 2513 courses) or amoxicillin (1009 patients, 2358 courses) and followed prospectively to determine the relative incidence and character of adverse events. Patients were from 1 month to 16 years old. Otitis media, the principal diagnosis, occurred in 883 patients (2014 episodes) receiving cefaclor and in 856 (1888 episodes) receiving amoxicillin. Others were diagnosed as having pharyngitis (482 episodes), bronchitis (267 episodes), sinusitis (130 episodes), pneumonia (63 episodes) and urinary tract infection (27 episodes). Adverse events were elicited by telephone during therapy and by follow-up for 2 weeks after therapy and were reported in 5.7% of the cefaclor courses and 5.2% of courses of amoxicillin. Serum sickness-like reactions and erythema multiforme occurred in 5 and 6 children, respectively, given cefaclor (1.1%) and in no children given amoxicillin. Children in the cefaclor group had a greater incidence of urticaria. Other adverse experiences, including gastrointestinal events, were approximately equally distributed for the two groups.

Adolescent↗
PubMed1991

Comparative efficacy of erythromycin-sulfisoxazole, cefaclor, amoxicillin or placebo for otitis media with effusion in children.

We randomly assigned children with otitis media with effusion to receive either erythromycin-sulfisoxazole, cefaclor, amoxicillin or placebo for a 2-week period, primarily to determine whether either erythromycin-sulfisoxazole or cefaclor would have greater short term efficacy than that found previously for amoxicillin, and secondarily to supplement earlier data on outcomes in placebo-treated subjects. Interim analyses showed no statistically significant (P less than 0.05) differences between the three antimicrobial treatment groups in the primary outcome measures, i.e. the prevalence of middle-ear effusion 2 and 4 weeks after entry, and indicated that postulated differences favoring the erythromycin-sulfisoxazole and cefaclor groups over the amoxicillin group were unlikely to be found even if the originally calculated sample size were attained. Subject accrual was therefore terminated. Final analysis showed no significant between-group differences in other outcome measures as well. In antimicrobial vs. placebo comparisons neither erythromycin-sulfisoxazole nor cefaclor gave more favorable outcomes than placebo, whereas more children were effusion-free in the amoxicillin group than in the placebo group at 2 weeks (31.6% vs. 14.1%, P = 0.007), but not at 4 weeks. We conclude that when antimicrobial treatment for otitis media with effusion is deemed advisable, neither erythromycin-sulfisoxazole nor cefaclor should replace amoxicillin as first line treatment.

Amoxicillin↗
PubMed1992

Loracarbef vs. cefaclor in pediatric skin and skin structure infections.

A double blind, randomized clinical trial involving 214 children, ages 6 months to 12 years, compared the safety and effectiveness of the new carbacephem loracarbef and the cephalosporin cefaclor for the treatment of skin and skin structure infections. The two agents were given primarily as oral suspensions. Dosages were 15 mg/kg/day in two divided doses for loracarbef and 20 mg/kg/day in three divided doses for cefaclor. Assessment 72 hours after completion of the 7-day course of treatment indicated a favorable clinical response plus eradication of the pretherapy pathogen in 97.3% of the 74 loracarbef-treated patients eligible for evaluation and 92.3% of 78 evaluable cefaclor-treated patients. Favorable response rates at a second posttreatment visit 10 to 14 days after the end of therapy were 95.6% in 68 evaluable loracarbef-treated patients and 86.2% in 65 treated with cefaclor. The incidence of adverse reactions, including gastrointestinal effects, was low in both groups. No statistical difference in clinical or bacteriologic efficacy or safety was detected between patients treated with loracarbef and cefaclor.

Cefaclor↗
PubMed1993

A comparative evaluation of cefaclor and amoxicillin in the treatment of acute otitis media.

In an earlier study of 214 children with acute otitis media (AOM) randomly assigned to a 14-day course of either cefaclor or amoxicillin, 55.7% of cefaclor-treated subjects were effusion-free compared with 41.2% of amoxicillin-treated subjects at the end of treatment. The present study was conducted to determine whether, in a 1-year period, subjects treated with cefaclor for each episode would have middle ear effusion for significantly less time than those treated with amoxicillin for each episode. One hundred fifty-seven subjects with AOM were enrolled. No statistically significant differences were found between the cefaclor-treated and amoxicillin-treated groups in number of subjects effusion-free immediately after first treatment (47.9% vs. 42.3%, respectively), average percent of time with effusion (22.2% vs. 23.4%, respectively), or in rate of new episodes of AOM (3.05 vs. 3.26, respectively). We conclude that there is no clinically significant advantage to the use of cefaclor rather than amoxicillin as the routine first line drug in the treatment of AOM.

Acute Disease↗
PubMed1997

Comparison of cefdinir and cefaclor in treatment of community-acquired pneumonia.

Six hundred ninety patients were enrolled in a multicenter, randomized, double-blind trial comparing the efficacy and safety of cefdinir with those of cefaclor in the treatment of community-acquired pneumonia. Patients received either 10 days of treatment with cefdinir (n = 347) at 300 mg twice daily or 10 days of treatment with cefaclor (n = 343) at 500 mg three times daily. Microbiological assessments were performed on sputum specimens obtained at admission and at the two posttherapy visits, if available. Respiratory tract pathogens were isolated from 538 (78%) of 690 patient admission sputum specimens, with the predominant pathogens being Haemophilus parainfluenzae, Haemophilus influenzae, Streptococcus pneumoniae, and Staphylococcus aureus. The microbiological eradication rates at the test-of-cure visit were 92% (238 of 260 pathogens) and 93% (245 of 264 pathogens) for the evaluable patients treated with cefdinir and cefaclor, respectively. A satisfactory clinical response (cure plus improvement) was achieved in 89% (166 of 187) and 86% (160 of 186) of the evaluable patients treated with cefdinir and cefaclor, respectively. Except for the incidence of diarrhea, adverse event rates while on treatment were equivalent between the two treatment groups. Diarrhea incidence during therapy was higher for patients treated with cefdinir (13.7%) than for patients treated with cefaclor (5.3%). These results indicate that cefdinir is effective and safe in the treatment of patients with pneumonia.

Adolescent↗
PubMed1997

Cefaclor, an alternative to third generation cephalosporins for the treatment of gonococcal urethritis in the developing world?

OBJECTIVE: To reassess the in vivo and in vitro efficacy of cefaclor for the treatment of uncomplicated gonococcal infection. DESIGN: Open clinical trail conducted in South Africa among consecutive male patients with symptoms and signs of uncomplicated urethritis and laboratory evidence of gonorrhoea. METHODS: Patients were treated with 3 g of cefaclor plus 1 g probenecid as a single dose. Urethral specimens were cultured for Neisseria gonorrhoeae at the initial visit and at follow up. Patients were considered cured if follow up cultures were negative. Treatment was considered to have failed in the patients infected with identical gonococcal strains at the initial and at the control visit. Those with evidence of infection at the follow up visit were administered 400 mg of ofloxacin and doxycycline 100 mg twice daily for 7 days. Minimal inhibitory concentrations (MICs) of cefaclor were determined by an agar dilution technique on the gonococcal isolates from the study subjects. The results were compared with those of isolates from three other African countries. RESULTS: Of 155 patients evaluated, 151 were cured (97%). Thirty per cent of the patients complained of adverse effects, mainly gastrointestinal. Even though MICs for the isolates from the three other African countries were significantly higher than those for the isolates from the study, none was considered resistant to cefaclor in vitro. MICs were markedly influenced by the type of test medium used. CONCLUSION: The trial demonstrated the efficacy of a single oral dose of cefaclor with probenecid for the treatment of uncomplicated gonococcal urethritis in South Africa. Its potential as an alternative therapy to third generation cephalosporins deserves to be further investigated.

Administration, Oral↗
PubMed1998

Cefaclor: a contemporary look at susceptibility of key pathogens from around the globe.

The orally administered cephalosporin antibiotic, cefaclor, has been available for clinical use in many countries since 1979. Because widespread antibiotic use is often cited as a factor in the emergence of bacterial resistance to antibiotics, we sought to determine the degrees of resistance to cefaclor expressed by key pathogens recently isolated in 10 countries widely distributed around the world. Using the E-test, minimal inhibitory concentrations (MIC) were determined for cefaclor and several comparator antibiotics against approximately 700 fresh clinical isolates of each of six bacterial species. The results demonstrated that > 90% of Haemophilus influenzae (beta-lactamase producing and non-producing), Haemophilus parainfluenzae (beta-lactamase producing and non-producing), Moraxella catarrhalis (> 90% beta-lactamase producing), and methicillin-susceptible Staphylococcus aureus, and 85% of Escherichia coli were susceptible to cefaclor at the NCCLS interpretive breakpoints. MIC distributions showed that there has been no change in the activity of cefaclor against penicillin-susceptible strains of Streptococcus pneumoniae since 1977.

Anti-Infective Agents↗