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The efficacy and safety of two fluoroquinolone antimicrobial agents, lomefloxacin and ciprofloxacin, were compared in a randomized, investigator-blinded, multiple-dose study that enrolled 150 adult outpatients with complicated or recurrent urinary tract infections. A total of 75 patients were treated with 400 mg of lomefloxacin once daily for 10-14 days; an equal number of patients received 500 mg of ciprofloxacin every 12 hours for 10-14 days. Both groups of patients were comparable in terms of demographics and distribution of underlying conditions. The most frequently occurring pathogens in both groups were Escherichia coli and Klebsiella pneumoniae. A total of 142 patients met the criteria for efficacy evaluation, 72 in the lomefloxacin group and 70 in the ciprofloxacin group. Eradication of the initial pathogen (post-treatment culture of less than or equal to 10(4) colony-forming units (CFU)/mL) was noted in 97.2% of patients treated with lomefloxacin and in 95.7% of ciprofloxacin-treated patients. Clinical success (disappearance or amelioration of presenting signs and symptoms) occurred in 98.6% of lomefloxacin-treated patients and in 95.7% of patients treated with ciprofloxacin. The differences in outcome between the two treatment groups were not statistically significant. Both drug regimens were well tolerated. There were no clinically significant changes in clinical laboratory values during treatment. In the lomefloxacin group three patients reported nausea, one nervousness, and one pruritus; in the ciprofloxacin group, two patients reported nausea and three pruritus. Two lomefloxacin-treated patients (3%) and four patients treated with ciprofloxacin (5%) withdrew from treatment because of adverse events. A single daily dose of 400 mg lomefloxacin was comparable to 500 mg ciprofloxacin every 12 hours for the treatment of complicated or recurrent urinary tract infections.
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PMID:A comparison of the safety and efficacy of lomefloxacin and ciprofloxacin in the treatment of complicated or recurrent urinary tract infections. 131 77

Cefprozil is a new oral semi-synthetic cephalosporin with broad antibacterial spectrum and prolonged serum elimination half-life. In vitro, cefprozil demonstrates excellent activity against common urinary tract pathogens such as Escherichia coli and Klebsiella pneumoniae. Cefprozil, 500 mg once a day, was compared to cefaclor, 250 mg three times a day, in an open, randomized, comparative, clinical trial for the treatment of acute, uncomplicated, urinary tract infection. One hundred and two adult patients were eligible for safety evaluation; four patients were excluded due to side-effects (abdominal discomfort, nausea and vomiting). Ninety-eight patients were eligible for evaluation of efficacy. Clinical and bacteriological responses were comparable for both antibiotics. Leucopenia, nausea, and vaginal yeast infections were slightly more common in the cefprozil group. Cefprozil, 500 mg once daily, appears to be an appropriate alternative for the treatment of acute, uncomplicated urinary tract infections.
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PMID:Comparative efficacy and safety of cefprozil and cefaclor in the treatment of acute uncomplicated urinary tract infections. 176 53

In a prospective, open clinical study, 50 urological patients with acute pyelonephritis were treated with the oral cephalosporin cefixime. The medication (2 x 200 mg/day) was given for seven to ten days. Clinical, bacteriological as well as hematological examinations were carried out prior to, during and immediately after therapy. A late check-up was performed five to nine days after the end of therapy. 46 of the 50 cases were evaluable for efficacy, and all 50 patients were included in safety evaluation. The most frequent pathogens isolated prior to therapy were Escherichia coli (34 times), Proteus mirabilis (six times), Klebsiella pneumoniae (twice) and coagulase-negative staphylococci (twice). Immediately after the end of therapy the pathogens were eradicated in 44 (97.5%) patients. At the late check-up the urine was sterile in 29 (63%) patients. A relapse was observed in 11 patients, a reinfection in four and the initially isolated pathogens had persisted in two. Immediately after the end of therapy 44 (95.7%) patients were clinically cured and two patients had improved. At the late check-up 41 patients were classified as clinically cured, three showed improvement, and two improvement with relapse. Adverse reactions (one case nausea and exanthem, and one case of meteorism) occurred in two patients. No changes in the blood counts or in the liver and kidney functions were observed. In the study described here cefixime proved to be an effective and well tolerated antibiotic for the treatment of upper urinary tract infections; it is of particular interest that 16 of the 50 patients presented with underlying disease favoring infection.
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PMID:[Effectiveness and tolerance of cefixime in the treatment of acute pyelonephritis]. 207 74

A total of 27 patients, 21 of them females, with a median age of 56 were treated with pefloxacin for urinary tract infections. Some 74% of these infections were associated with upper tract symptoms, and Escherichia coli was the most common causative micro-organism (75% of cases). Fifteen patients had co-existent diseases with/without urological abnormalities. All strains of E coli were sensitive to pefloxacin; Actinobacter and one strain of Klebsiella and Streptococcus faecalis were resistant. Two patients who defaulted and one who had an initial negative bacterial culture were excluded from the analysis of the outcome. The overall bacteriological cure rate at four to eight weeks was 87.5% (21/24). The incidence of possible side-effects was high, occurring in 59% of the patients. Nausea, dizziness and vomiting were the most common. These were mild and did not require termination of treatment. Peripheral neuropathy, which disappeared four weeks after stopping pefloxacin, occurred in one patient.
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PMID:Clinical experience with pefloxacin in patients with urinary tract infections. 210 45

In a double-blind randomized trial, we evaluated the efficacy and safety of three oral dosage regimens of fleroxacin, a new fluoroquinolone, once daily in 62 patients for the treatment of complicated urinary tract infections. The regimens compared were 200 mg for 10 days (n = 20), 400 mg for 10 days (n = 21), and 600 mg for 10 days (n = 21). Forty-five patients were evaluable for efficacy. A clinical cure was reached in 78% of the patients. Overall, a favorable bacteriological response (negative culture or reinfection at 4 to 6 weeks) was obtained in 36 of 45 (80%) patients. No significant difference could be found among the three dosage groups. During therapy, one Klebsiella ozaenae strain became resistant and one Pseudomonas aeruginosa strain became less susceptible to fleroxacin. In 13 patients, therapy had to be discontinued due to major adverse events (oliguria [n = 1], psychosis [n = 1], photosensitivity [n = 1], insomnia [n = 1], and nausea [n = 9]). Minor side effects were seen in 13 other patients. Increased dosage correlated significantly (P less than 0.01) with total number of adverse events.
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PMID:Double-blind, dose-range-finding study of fleroxacin (RO 23-6240; AM-833) for treatment of complicated urinary tract infections. 211 Apr 37

In an open study, 70 in-patients and 23 out-patients aged between 1 and 14 years with sinusitis (n = 1), perforated otitis media (n = 4), pharyngotonsillitis (n = 25), tracheobronchitis (n = 30) or broncho-pneumonia (n = 33) were treated daily with a combination of 40 mg/kg amoxycillin and 10 mg/kg clavulanic acid in three equal doses for between 6 and 15 days. Purulent specimens were cultured when obtainable and pathogenic organisms identified were Staphylococcus aureus, beta-haemolytic streptococcal group A, Pseudomonas aeruginosa, Pseudococcus species and Klebsiella pneumoniae infections, of which 45.7% were beta-lactamase-producing and 54.3% were ampicillin-susceptible. After treatment, only one beta-lactamase-producing Streptococcus and one Staphylococcus infection persisted. Side-effects (vomiting, nausea, diarrhoea, maculopapular exanthema, rash) occurred in 16 patients and treatment was withdrawn in eight. It is concluded that the amoxycillin--clavulanic acid combination is a suitable first choice for the treatment of respiratory tract infections in children in whom the pathogenic organism may not have been established.
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PMID:Treatment of respiratory tract infections in children: a study of a combination of amoxycillin and clavulanic acid. 222 80

A vaccine has been prepared with ribosomes of Candida albicans serotypes a and b plus, as adjuvant, membrane proteoglycan from a nonencapsulated Klebsiella pneumoniae. A preliminary phase II trial without placebo control was conducted in 22 women with a history of frequent recurrences of vulvovaginal candidiasis (VVC). Initially, all the patients were treated locally with an antimycotic cream. Beginning at the same time, vaccine was taken orally in capsules containing 0.55 microgram active components. It was administered intermittently over six months, groups of women taking doses of two, three, six or nine capsules. Tolerance was excellent except for mild nausea, probably due to the excipients, in two patients taking nine capsules. Twenty patients completed the study. Only seven of them had a documented recurrence of VVC during the 6 months on vaccine. No recurrence occurred in the eight women taking six or nine capsules per day. Before the study, these 20 patients had had an average of 3.59 attacks of VVC per 6 months. On vaccine, the average rate of recurrence was only 0.55 attacks per 6 months. A multicentre placebo-controlled study of the efficacy of this vaccine is in progress to validate these encouraging preliminary results.
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PMID:Phase II study of D.651, an oral vaccine designed to prevent recurrences of vulvovaginal candidiasis. 268 57

A 35-year-old obese black American woman presented with nausea, vomiting, diarrhea, fever, cough, and chest pain of 2 weeks duration. She was pancytopenic and acidotic, with respiratory failure and hypotension. A diagnosis of septic shock was made, and the patient died 48 hours after admission. Blood cultures were positive for organisms that were reported to be Klebsiella rhinoscleromatis. At autopsy she had massive hepatic necrosis with numerous Mikulicz's cells. The lungs, spleen, and bone marrow were also involved. To our knowledge, this is the first report of a case of systemic infection with K rhinoscleromatis.
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PMID:Disseminated Klebsiella rhinoscleromatis infection. 268 80

In a single-blind, placebo-controlled randomized trial, 100 successive patients were enrolled with serious skin and soft-tissue infections, whose illnesses had precipitated an initial hospital admission or an extension of inpatient care. There were 93 evaluable patients who received either ofloxacin, 400 mg orally every 12 hours plus an intravenously administered placebo every eight hours, or cefotaxime, 2.0 g intravenously every eight hours plus an orally administered placebo every 12 hours. The average length of therapy was 12 days. Both patient groups had similar demographics and underlying conditions. Wound infection was the most common diagnosis, followed by abscess, cellulitis, and trophic ulcer. Multiple pathogens were commonly isolated from infected sites (1.4 pathogens/patient). The most common pathogen was Staphylococcus aureus, followed by Escherichia coli, Klebsiella spp., Pseudomonas aeruginosa, Serratia marcescens, Proteus/Providencia spp., and Enterobacter spp. Persistence of the initial pathogen at the end of therapy was observed in 22.5 percent of the cefotaxime-treated group, but in only 10 percent of the ofloxacin-treated group. There was one clinical failure in the cefotaxime group, caused by a susceptible strain of Enterobacter cloacae, and there was one clinical failure in the ofloxacin group, in which the patient had an Acinetobacter calcoaceticus var. anitratus wound infection and subsequently developed a P. aeruginosa superinfection. Adverse experiences, including rash, insomnia, and nausea, occurred in 16 percent of the patients in each group. It was concluded that oral ofloxacin is as safe and efficacious as parenteral cefotaxime in the treatment of serious skin and skin structure infections.
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PMID:A comparative evaluation of oral ofloxacin versus intravenous cefotaxime therapy for serious skin and skin structure infections. 269 Jun 21

Lomefloxacin (NY-198), a new antimicrobial quinolone, was examined for its antimicrobial activities against clinical isolates and clinical efficacies to biliary tract infections. The following results were obtained. 1. The MICs of NY-198 against Escherichia coli (20 strains) and Klebsiella pneumoniae (20 strains) were good and similar to those of ofloxacin (OFLX) or norfloxacin (NFLX). The MICs of NY-198 against Pseudomonas aeruginosa (20 strains) were inferior by 1 dilution factor to OFLX or NFLX, and against Enterococcus faecalis (10 strains), they were similar to NFLX and slightly inferior to OFLX. 2. NY-198 was administered to 8 patients with biliary tract infections (acute cholecystitis 7 cases, chronic cholangitis 1 case). The results were good in 7 and unevaluable in 1 case because the duration of the therapy was too short. 3. As for side effects, mild urticaria was observed in 1 case and epigastralgia with nausea in another. As for abnormal laboratory test values slight elevations of GOT and GPT were recognized in 1 case. 4. In conclusion, we consider NY-198 is a useful oral drug for the treatment of biliary tract infections.
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PMID:[Studies of lomefloxacin in biliary tract infections]. 276 34


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