We compared intravenously administered ciprofloxacin (CPFX) with ceftazidime (CAZ) in a randomized, well-controlled manner in terms of clinical efficacy, safety and usefulness. Patients with moderate to severe bacterial pneumonia received either CPFX 300 mg b.i.d. or CAZ 2g b.i.d. intravenously for 14 days. The following results were obtained in this trial:
1. A total of 201 patients were enrolled in this study. The cases evaluable for clinical efficacy, safety and usefulness were 91, 98 and 95 in the CPFX group, and 75, 87 and 80 in the CAZ group, respectively. Although a statistical bias was found in the severity of infections, it had no effect on the evaluation of clinical efficacy.
2. The clinical efficacy rate was 85.7%(78/91) in the CPFX group and 84.0%(63/75) in the CAZ group. There was no statistically significant difference between the two groups, and the statistical equivalence between them was shown at Δ=10%.
3. The elimination rate of causative organisms was 78.9%(30/38) in the CPFX group and 100%(28/28) in the CAZ group. Statistical significance was demonstrated between these values (p=0.017, Fisher's exact test).
4. Side effects were noted in 11.1%(11/99) in the CPFX group and 13.8%(12/87) in the CAZ group. The major events were local reactions at injection sites, hypersensitivity symptoms and central nervous system disorders.
5. Abnormal laboratory findings were detected in 22.3%(21/94) in the CPFX group and 29.4%(25/85) in the CAZ group. The major events were eosinophilia and elevation of transaminases.
6. The safety rate was 70.4%(69/98) in the CPFX group and 63.2%(55/87) in the CAZ group. There was no significant difference between these values.
7. The ratios judged as better than useful in the CPFX and CAZ groups were 76.8%(73/95) and 77.2%(61/80), respectively, not significantly different.
These results indicate that CPFX is a highly effective drug for the treatment of bacterial pneumonia.

View full abstract

The efficacy, safety and usefulness of injectable ciprofloxacin (CPFX) were investigated in a clinical study involving treatment of patients with severe and/or refractory infections in the internal medicine field. The test drug was administered by intravenous drip infusion at a dose of 300mg (as CPFX), twice daily for 3 to 14 days. A total of 66 cases were enrolled in this study: 16 cases with chronic bronchitis, 23 with infectious bronchiectasis, 20 with secondary infection with chronic respiratory disease and 2 with empyema, but 5 cases had ineligible diseases. The clinical efficacy rate was 69.1%(38/55 cases), being 92.3%(12/13) for chronic bronchitis, 59.1%(13/22) for infectious bronchiectasis, 72.2%(13/18) for secondary infection with chronic respiratory disease. The subtotals were 71.7%(38/53) for the above chronic lower RTIs and 0/2 for empyema. The efficacy rate in poor responders to antibiotic pretreatment was 66.7%(8/12 cases). The elimination rate of causative organisms was 65.7%(23/35 strains), in terms of bacteriological efficacy. Side effects were noted in 11.3%(7/62) with 10 events. The major signs and symptoms were central nervous system disorders and gastro-intestinal symptoms, all of which were mild to moderate, and disappeared during treatment or after the completion of treatment or drug discontinuation. Abnormal laboratory findings were seen in 13.1%(8/61) with 19 events, mostly GOT, GPT and/or γ-GTP elevation. In the evaluation of overall safety, a safety rate of 77.4%(48/62 cases) was obtained, yielding a 62.1%(36/58 cases) usefulness rate. Therefore, the present study confirmed good effectiveness and safety for injectable CPFX in the treatment of severe and/or refractory chronic airway infections.

View full abstract

A clinical investigation of intravenous ciprofloxacin (CPFX) in the surgical and gynecological fields was conducted in patients with sepsis, peritonitis, biliary tract infections, secondary infections (due to trauma, burns and operative wounds) and gynecological infections, all of which were severe and/or refractory. CPFX was administered intravenously 300 mg twice a day for 3 to 14 days to 87 patients: 4 with sepsis, 22 with peritonitis, 11 with biliary tract infections, 33 with secondary infections, 13 with gynecological infections and 4 with other infections. The clinical efficacy rate was 85.1%(63/74 cases): 100%(2/2 cases) with sepsis, 88.2%(15/17 cases) with peritonitis, 63.6%(7/11 cases) with biliary tract infections, 90.6%(29/32 cases) with secondary infections and 83.3%(10/12 cases) with gynecological infections. The eradication rate of causative organisms was 67.9%(55/81 strains) in terms of bacteriological efficacy. Side effects were noted in 1 case (1.2%) who developed anemia. Abnormal laboratory findings were observed in 18 cases (21.2%) and major findings were increased eosinophil counts and elevated transaminases. The evaluations of overall safety and usefulness were 80.0%(68/85 cases) and 83.8%(62/74 cases), respectively. Therefore, we found that intravenous CPFX is a highly effective drugs for severe and/or refractory surgical infections in the surgical and gynecological fields.

View full abstract

A 79-year-old man with chronic bronchitis was suffered from repeated exacerbations of Haemophilus influenzae infection, and frequent fluoroquinolone treatments were applied. The bacterial strains isolated from the early episodes were reported to be susceptible to ofloxacin or other antibiotics by routine disk susceptibility test, and frequent fluoroquinolone treatment was given. However, oral cephalosporine treatment did not achieve complete remission or bacterial eradication after this episode. Finally, he was treated by double-blind comparative trial of AM-1155 and levofloxacin, which failed to eradicate H. influenzae. The strains isolated from his sputum during and after the therapy were resistant to ofloxacin. The MICs of these strains against various fluoroquinolones were 2-32μg/ml, which were considered to be high enough to cause treatment failures.

View full abstract

The drug susceptibility pattern of clinical isolates from perforative peritonitis (first level) obtained in 1996 was investigated. The results are summarized as follows:
1. Extend-spectrum β-lactamase (ESBL) producers of similar β-lactamase producers are present in multiple drug resistant strains of Escherichia coli. The drug susceptibility patterns were divided into 14 patterns against 50 isolated strains. We found that 6 cefotiam (CTM)-resistant strains were also ampicillin (ABPC) and cefazolin (CEZ)-resistant, and 3 strains of cefmetazole (CMZ)-resistant strains were.
2. Piperacillin (PIPC) and CEPs-resistant strains of Peptostreptococcus spp. were about 20%.
3. The frequency of detection of CMZ-resistant Bacteroides fragilis group was high and the MIC90's of PIPC, CEZ, CTM and CMZ were high for both low and high β-lactamase producers. These results, strongly suggest that the resistance of the B. fragilis group to those drugs is caused by β-lactamase.
4. The frequency of detection of β-lactamase-producing Prevotella spp. was high, and the drug susceptibility pattern of β-lactamase producers was similar to that of the B. fragilis group.
5. Antimicrobial activities of sulbactam/cefoperazone (SBT/CPZ) against CEPs-resistant E. coli, ABPC and SBT/ABPC against CEPs-resistant Peptostreptococcus spp. and SBT/ABPC and SBT/CPZ against β-lactamase-producing Prevotella spp. were strong.
6. Parts of the B. fragilis group and Prevotella spp. were presumed etiologic agents of polymicrobial infection and β-lactamase in these bacterial species influenced indirectly to antimicrobial activity of CEPs. These results, the B. fragilis group and Prevotella spp. were direct and indirect pathogenicity of perforative peritonitis.

View full abstract

The agar dilution method was used to compare the in vitro activity of faropenem (FRPM) with that of sultamicillin (SBTPC), levofloxacin (LVFX) and clarithromycin (CAM) against 500 bacterial clinical isolates. FRPM was active against Staphylococcus, Streptococcus and Enterococcus. In particular, all penicillin-resistant strains of Streptococcus pneumoniae were susceptible at ≤0.39μg/ml. FRPM showed the same activity as LVFX against all Enterobacteriaceae, but almost all Citrobacter and Enterobacter strains were less susceptible. The MIC₉₀ of FRPM for the Bacteroides fragilis group, Peptostreptococcus, and Propionibacterium acnes was 0.39, 0.39 and 0.05μg/ml, respectively. These results suggest that faropenem has excellent in vitro antibacterial activity against clinical isolates and is a clinically useful oral antibiotic for the treatment of bacterial infections.

View full abstract