Comparison of cefprozil and cefaclor for treatment of acute urinary tract infections in women.

A total of 108 college women with acute urinary tract infections were treated for 10 days with either 500 mg of cefprozil (BMY-28100-03-800) once a day (n = 72) or 250 mg of cefaclor three times a day (n = 36). Clinical and bacterial cure rates at 1 week posttherapy were 94 and 93%, respectively, for the cefprozil group and 94 and 94%, respectively, for the cefaclor group (P, not significant). Both cefprozil and cefaclor were safe and effective.     

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.     

Prospective comparison of amoxicillin-clavulanic acid and cefaclor in treatment of uncomplicated urinary tract infections.

Patients with acute, uncomplicated urinary tract infections were treated with either amoxicillin-clavulanic acid (A-C) in fixed combination or cefaclor for 10 days in a prospective randomized comparison. The A-C group included 29 women and 1 man (mean age, 25.5 years), and the cefaclor group included 35 women and 1 man (mean age, 24.9 years). The cure rates were 26 (87%) of 30 with A-C and 26 (72%) of 36 with cefaclor (P greater than 0.20). There was one failure in each group, each caused by an isolate resistant to ampicillin. There were one relapse and two reinfections in the A-C group, compared with seven relapses and two reinfections in the cefaclor group. Side effects, including patients started on antibiotics but whose cultures did not confirm urinary tract infections, were diarrhea in 7 (16%) and rash in 1 (2%) of 44 A-C patients, compared with diarrhea in 1 (2%) and yeast vaginitis in 3 (6%) of 48 cefaclor patients. Although the A-C group had a greater proportion of antibody-coated bacterium-positive infections (22 versus 18 with cefaclor), there was a lower recurrence rate with fewer relapses in patients treated with A-C.     

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

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

Cefdinir versus cefaclor in the treatment of uncomplicated urinary tract infection

OBJECTIVE: This multicenter, double-blind, randomized, parallel-group study was conducted in Europe, South Africa, and Australia to compare the clinical and microbiologic efficacy and the tolerability of a cephalosporin antibiotic, cefdinir, with those of cefaclor in the treatment of uncomplicated urinary tract infection. METHODS: Patients were randomized in a 1:1 ratio to 5 days of treatment with either cefdinir 100 mg BID or cefaclor 250 mg TID. RESULTS: A total of 661 patients were randomized to treatment. They were 90% female, with a median age of 44 years. There were no clinically important differences between groups in terms of demographic characteristics or symptoms on admission. The most frequently isolated pathogens in admission urine cultures were Escherichia coli (383 patients), Proteus mirabilis (20 patients), Staphylococcus saprophyticus (14 patients), and Klebsiella pneumoniae (9 patients). Of the admission pathogens with documented susceptibility results, significantly more were resistant to cefaclor (6.7%) than to cefdinir (3.7%; P < 0.003). Significantly more admission isolates of E. coli were resistant to cefaclor (5.1%) than to cefdinir (2.0%; P < 0.007). A total of 383 patients were assessable for efficacy, 196 in the cefdinir group and 187 in the cefaclor group. Clinical cure rates and microbiologic response rates for cefdinir and cefaclor were statistically equivalent at 5 to 9 days posttherapy (test-of-cure visit), using a 95% CI approach. The rate of treatment-related adverse events was higher in cefdinir-treated patients (20.2%) than in cefaclor-treated patients (13.0%; P = 0.025), mainly due to the greater frequency of diarrhea in the former group. However, only 4 patients (1.2%) discontinued cefdinir treatment due to diarrhea. CONCLUSION: Empiric therapy with cefdinir appears to be a reasonable choice for patients with uncomplicated urinary tract infection in whom cephalosporin treatment is indicated.     

Single-dose cefuroxime axetil versus multiple-dose cefaclor in the treatment of acute urinary tract infections.

Eighty-nine college women with acute urinary tract infections were treated orally with either 1,000 mg of cefuroxime axetil in a single dose (n = 59) or 250 mg of cefaclor three times a day for 7 days (n = 30). At 1 week posttherapy, 88% of the patients in the cefuroxime axetil group and 97% in the cefaclor group were clinically and bacteriologically cured (P greater than 0.10). There was no statistically significant difference between the cure rates of the two treatment groups. However, this study has only a 50% power to detect a 10% difference. Therefore, there is a substantial possibility of a type II error, i.e., failing to find a difference that is actually present. At 4 weeks posttherapy, 78% of the patients in the cefuroxime group and 80% in the cefaclor group remained cured. By 36 weeks posttherapy, the cumulative rate of recurrence in both treatment groups was 60%. Of the patients with a positive antibody-coated bacteria test, fewer achieved a short-term cure after single-dose treatment with cefuroxime axetil than those with a negative antibody-coated bacteria test (67 versus 96%; P less than 0.01).     

Loracarbef versus cefaclor in the treatment of urinary tract infections in women.

In a double-blind, prospective, randomized study, 108 college women with acute urinary tract infections were treated for 7 days with either loracarbef (LY163892) at 200 mg once daily (n = 53) or cefaclor at 250 mg three times daily (n = 55). The cure rates at 5 to 9 days after treatment in the loracarbef and cefaclor groups were 96 and 90%, respectively. Both loracarbef and cefaclor are safe, well tolerated, and effective in the treatment of urinary tract infections in women.     

Comparative efficacy and safety of nalidixic acid versus trimethoprim/sulfamethoxazole in treatment of acute urinary tract infections in college-age women.

One hundred and thirty-five college-age women with acute urinary tract infections caused by gram-negative Enterobacteriaceae were treated by random allocation with either nalidixic acid (NA), 1 g every 6 h for 7 days, or trimethoprim/sulfamethoxazole (TMP/SMZ), 160/800 mg every 12 h for 10 days. The clinical and bacteriological cure rates were 98.0% in each group on the last day of therapy. At 1 and 4 week posttherapy, both the clinical and bacteriological cure rates for NA declined to 90.0 and 74.0% respectively; for TMP/SMZ, they declined to 93.0 and 72.0% respectively. By 4 weeks posttherapy, 96.0% of the TMP/SMZ group and 93.0% of the NA group had remained free of the initial urinary pathogens. Neither drug was associated with emergence of resistant bacterial mutants in urine. The antibody-coated bacteria tested (ACBT) localized 31.5% of the infections of the kidney and 67.7% to the bladder. Upper tract symptoms did not correlate with the presence of a positive ACBT. The response to therapy was similar for the two regimens regardless of ACBT results. After treatment, the emergence of resistant Enterobacteriaceae in fecal flora was 1.1% in the NA group and 2.3% in the TMP/SMZ group. The incidences of drug reactions were 7.0% with NA and 6.3% and TMP/SMZ.     

Single-dose amoxicillin therapy of acute uncomplicated urinary tract infections in women.

Of 210 women who were experiencing dysuria, frequent urination, pyuria, and significant bacteriuria and who were treated with a single 3-g dose of amoxicillin, 165 (79%) were cured of their original infections. Patients with infections that were negative by antibody-coated-bacteria assay were cured at a significantly higher rate than those with infections that were positive by antibody-coated-bacteria assay (90 versus 59%; P less than 0.001). Similarly, those with infections caused by amoxicillin-susceptible organisms were cured at a significantly higher rate than those with infections caused by resistant organisms (85 versus 50%; P less than 0.001). Of 27 patients who had infections caused by amoxicillin-susceptible organisms and who had relapses after single-dose therapy, 14 (52%) had relapses again after a conventional 10-day course of therapy, although all responded to a 6-week course. An additional 27 patients experiencing dysuria, frequent urination, and pyuria but who had a lower number of uropathogens in the urine (10(2) to 10(4.5)/ml of urine) were treated with single-dose therapy, with a 100% eradication of organisms and an 89% rate of symptomatic relief.     

Comparative efficacy of cefadroxil and cefaclor in the treatment of skin and soft-tissue infections

A ten-day, randomized, open-label study was conducted to compare the efficacy of 1,000 mg of cefadroxil once daily and 250 mg of cefaclor TID in 200 black patients with skin and soft-tissue infections caused by microorganisms sensitive to these cephalosporins. Statistically, the clinical results with each drug were not significantly different: 91% efficacy with cefadroxil and 95% efficacy with cefaclor. The important difference between cefadroxil and cefaclor is the remarkably longer half-life of cefadroxil, which makes once-a-day dosing possible and offers greater patient convenience and the likelihood of better compliance. In an analysis of compliance, only 2% of the patients in the cefadroxil group (20 capsules given to each patient) returned unused capsules; 77% in the cefaclor group (30 capsules given to each patient) returned unused capsules.     

Diagnosis and management of uncomplicated urinary tract infections

Most uncomplicated urinary tract infections occur in women who are sexually active, with far fewer cases occurring in older women, those who are pregnant, and in men. Although the incidence of urinary tract infection has not changed substantially over the last 10 years, the diagnostic criteria, bacterial resistance patterns, and recommended treatment have changed. Escherichia coli is the leading cause of urinary tract infections, followed by Staphylococcus saprophyticus. Trimethoprim-sulfamethoxazole has been the standard therapy for urinary tract infection; however, E. coli is becoming increasingly resistant to medications. Many experts support using ciprofloxacin as an alternative and, in some cases, as the preferred first-line agent. However, others caution that widespread use of ciprofloxacin will promote increased resistance.     

Cefoperazone-sulbactam combination in the treatment of urinary tract infections: efficacy, safety, and effects on coagulation

Seventy hospitalized patients with upper urinary tract infections were treated with cefoperazone (2 gm) and sulbactam (1 gm) every 12 hours for three or more days. All but six patients also received vitamin K. Forty of the 70 patients (57%) were cured of infection at one week after treatment, 13 relapsed, 11 had reinfections, and six were lost to follow-up. There were no treatment failures. Escherichia coli was the predominant pathogen (62% of isolates). Overall there was 15% resistance to cefoperazone and all resistant isolates were susceptible to the combination of agents. Synergy was demonstrated in 26% of isolates. One uroseptic patient who had an organism resistant to both study agents, but susceptible to the combination, was cured. Two of six patients who did not receive vitamin K demonstrated abnormal coagulation patterns and one had an associated major bleeding complication. Although 12 of 64 (19%) patients who received vitamin K had at least one coagulation abnormality, there were no significant bleeding complications in this group.     

头孢丙烯与头孢克洛随机对照治疗下呼吸道感染患者的临床评价

目的　评价头孢丙烯与头孢克洛随机对照治疗下呼吸道感染的疗效和安全性。方法　轻、中度下呼吸道感染患者 12 0例随机分成两组 ,头孢丙烯组 6 2例予头孢丙烯 5 0 0mg ,口服 ,2次 /d ;头孢克洛组 5 8例予头孢克洛5 0 0mg ,口服 ,3次 /d。两组均以 7～ 14天为 1个疗程。结果　头孢丙烯组与头孢克洛组的临床有效率分别为 91.9%与 89.7% (P >0 .0 5 ) ,细菌消除率为 89.8%与 88.9% (P >0 .0 5 ) ,两组均无明显不良反应。结论　头孢丙烯可作为治疗轻、中度下呼吸道感染有效和安全的抗生素     

Uncomplicated urinary tract infections. Bacterial findings and efficacy of empirical antibacterial treatment

OBJECTIVE: To assess bacterial aetiology, antimicrobial susceptibility and efficacy of empirical treatment in uncomplicated urinary tract infections and to evaluate the dipstick as a diagnostic tool. DESIGN: Prospective study. SETTING: Clinical microbiology laboratory and 17 general practice clinics in Telemark County, Norway. SUBJECTS: A total of 184 female patients between 15 and 65 years of age with symptoms of uncomplicated urinary tract infection. MAIN OUTCOME MEASURES: Results from dipstick testing (leucocyte esterase and nitrite), bacterial culture, susceptibility patterns and efficacy of empirical antibacterial therapy on symptoms. RESULTS: Significant bacteruria was detected in 140 (76%) of the 184 urines. The leukocyte esterase test was of little help in predicting culture-positive UTI. A positive nitrite test accurately predicted culture-positivity, while a negative result was ambiguous. The most common bacterium, E. coli, was found in 112 (80%) of the 140 positive urines and was predominantly sensitive to ciprofloxacin (100%), mecillinam (94%), nitrofurantoin (97%), trimethoprim (88%), and sulphonamide (81%), and to a lesser extent to ampicillin (72%). In 18 patients the causative bacterium was resistant to the therapeutic agent used; 7 of these returned to their GP with persisting symptoms while in 11 symptoms resolved without further treatment. CONCLUSION: The study confirms E. coli as the predominant cause of uncomplicated UTI. Since in the majority of cases the bacterium found was susceptible to the locally preferred antimicrobials and the patients' symptoms were cured, empiric therapy is found to be an effective practice in the study area and, by inference, in others with similar antimicrobial susceptibility patterns.     

Amoxicillin-clavulanic acid versus cefaclor in the treatment of urinary tract infections and their effects on the urogenital and rectal flora.

In a double-blind randomized study, amoxicillin-clavulanic acid (AM-CL) was compared with cefaclor for the treatment of acute urinary tract infections in 107 college women. A total of 53 patients received amoxicillin (250 mg) and clavulanic acid as the potassium salt (125 mg), and 54 received cefaclor (250 mg); each drug was administered every 8 h for 10 days. The cure rates at 1 and 4 weeks after treatment were 96 and 78%, respectively, in the AM-CL group and 92 and 75%, respectively, in the cefaclor group (P greater than 0.10). After AM-CL treatment, the prevalence of amoxicillin-resistant Escherichia coli significantly increased in the rectal flora. Also, the frequency of bacterial resistance to amoxicillin, AM-CL, and cefaclor increased among the urinary pathogens causing subsequent urinary tract infections (P less than 0.05). There were no adverse reactions in the cefaclor group; however, six patients in the AM-CL group (12%) experienced diarrhea, nausea, or vomiting (P less than 0.05). Elevated transaminase enzyme levels were observed in 23% of the patients in the AM-CL group and in 6% of the patients in the cefaclor group (P less than 0.05). Symptomatic Candida vaginitis developed in 16 and 13% of the patients in the AM-CL and cefaclor groups, respectively (P greater than 0.10).     

Treatment of acute uncomplicated urinary tract infections with single daily doses of cefuroxime axetil

Cefuroxime axetil in a single daily dose of 250 mg for ten days was given to 75 women with symptoms of acute uncomplicated urinary tract infections. Fifty-nine women were found to have significant bacteriuria but one was excluded as urethral catheterization was required. The dose was taken at night with a milk drink. Ninety-five per cent of women had a clear urine during treatment. Compliance studies showed that antimicrobial activity was detectable in early morning urines up to 8-10 h after the dose. Post treatment, 93% of women were clear of their original infecting organism but five women had become reinfected with a different strain of Escherichia coli. At the six week follow up 98% of women were still clear although one further reinfection had occurred. The overall cure rate was 86%, including 11% reinfection. Adverse events developed in 17 (23%) of the 75 women with candida vaginitis (8) and diarrhoea (4) being most common. Cefuroxime axetil is a valuable therapy for the treatment of urinary tract infection particularly when due to beta-lactamase producing bacteria.     

Management of acute uncomplicated urinary tract infection in adults

Acute uncomplicated UTI is one of the most common problems for which young women seek medical attention, and it accounts for considerable morbidity and health care costs. Acute cystitis is a superficial infection of the bladder mucosa, whereas pyelonephritis involves tissue invasion of the upper urinary tract. Localization tests suggest that as many as one third of episodes of acute cystitis are associated with silent upper tract involvement. Acute cystitis or pyelonephritis in the adult patient should be considered uncomplicated if the patient is not pregnant or elderly, if there has been no recent instrumentation or antimicrobial treatment, and if there are no known functional or anatomic abnormalities of the genitourinary tract. Most of these infections are caused by E. coli, which are susceptible to many oral antimicrobials. Because of the superficial nature of cystitis, single-dose and 3-day regimens have gained wide acceptance as the preferred methods of treatment. Review of the published data suggests that a 3-day regimen is more effective than a single-dose regimen for all antimicrobials tested. Regimens with trimethoprim-sulfamethoxazole appear to be more effective than those with beta-lactams, regardless of the duration. Acute pyelonephritis does not necessarily imply a complicated infection. Upper tract infection with highly virulent uropathogens in an otherwise healthy woman may be considered an uncomplicated infection. The optimal treatment duration for acute uncomplicated pyelonephritis has not been established, and 14-day regimens are often used. We prefer to use antimicrobials that attain high renal tissue levels, such as trimethoprim-sulfamethoxazole or quinolones, for pyelonephritis. Women with frequently recurring infections can be successfully managed by continuous prophylaxis, either daily or thrice-weekly, by postcoital prophylaxis, or, in compliant patients, by early self-administration of single-dose or 3-day therapy as soon as typical symptoms are noted. Our drug of choice for all these regimens is trimethoprim-sulfamethoxazole. Acute uncomplicated cystitis in adult men is very uncommon, but it is occasionally noted in homosexual men who practice insertive and intercourse or in heterosexual men whose partners have vaginal colonization with E. coli.     

Comparative study of cephradine and amoxicillin-clavulanate in the treatment of recurrent urinary tract infections.

Eighty-eight female patients with a history of recurrent urinary tract infections were treated according to a randomization scheme with either 1 g of cephradine every 12 h (47 patients) or 375 mg of amoxicillin-clavulanate every 8 h (41 patients) for 7 days. The treatments were equally effective (cure rates of 89% for cephradine and 88% for amoxicillin-clavulanate) and showed similar relapse rates (cephradine, 14%; amoxicillin-clavulanate, 11%). Adverse effects were similar in both groups (cephradine, 23%; amoxicillin-clavulanate, 22%).     

Randomized comparative study of ceftibuten versus cefaclor in the treatment of acute lower respiratory tract infections

In a randomized, single-blind trial, ceftibuten in doses of 200 mg and 300 mg administered b.i.d., was compared with cefaclor 500 mg t.i.d. in acute lower respiratory tract infections. A total 545 patients were enrolled, of which 263 were evaluable for efficacy. All patients were adults with a diagnosis of either bacterial pneumonia or bronchitis. The infective organism was eliminated in 83% of the patients in the ceftibuten 200-mg b.i.d. treatment group and in 85% of patients in the 300-mg b.i.d. treatment group. The organisms were eliminated in 79% of cefaclor-treated patients. Satisfactory clinical responses were obtained in 91% of patients in the ceftibuten 200-mg b.i.d. treatment group and in 92% of patients in the ceftibuten 300-mg b.i.d. group. Satisfactory clinical responses were obtained in 91% of cefaclor-treated patients. Predominant pathogens isolated were Streptococcus pneumoniae, Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, and strains of Enterobacteriaceae. Adverse experiences reported were similar for the ceftibuten and cefaclor treatment groups. Gastrointestinal side effects occurred in 6% of patients treated with ceftibuten 200 mg BID, 9% in those treated with 300 mg BID, and 7% of cefaclor-treated patients. Ceftibuten 200 and 300 mg twice daily was as effective as cefaclor bacteriologically and clinically in the treatment of lower respiratory tract infections.