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Changes in the susceptibility of clinical isolates to faropenem and other antibiotics were investigated with the samples collected from the out-patients of respiratory or urinary tract infections at 382 facilities in Japan. The surveillances were conducted 6 times for every 2 months from February 1 st to March 31 st since 1998 to 2003. The incidence of methicillin-resistant Staphylococcus aureus (MRSA) was about 7% of all S. aureus isolates and that of methicillin-resistant Staphylococcus epidermidis (MRSE) was 42.9% to 58.3% of all S. epidermidis isolates. The incidence of penicillin-resistant Streptococcus pneumoniae (PRSP) increased from 2.7% to 19.0% of all S. pneumoniae isolates among 6 years. Imipenem (IPM) and faropenem (FRPM) had strong antibacterial activities against methicillin-susceptible S. aureus (MSSA) and methicillin-susceptible S. epidermidis (MSSE) and S. pneumoniae including PRSP. All β-lactam antibiotics had strong antibacterial activities against Streptococcus pyogenes. Clavulanic acid/amoxicillin (CVA/AMPC) had strong antibacterial activities against Enterococcus faecalis. Levofloxacin (LVFX) and IPM had strong antibacterial activities against gram-negative bacteria such as Branhamella catarrhalisand Escherichia coli. LVFX was the most active agent against Klebsiella spp. The incidence of β-lactamase-negative ampicillin-resistant Haemophilus influenzae (BLNAR) increased from 9.6% to 32.3% of all H. influenzae isolates among 6 years. LVFX was the most active agents against BLNAR. FRPM exhibited excellent antimicrobial activity against almost all strains except for MRSA, MRSE and BLNAR. The susceptibilities to FRPM of these strains have not changed among 6 years.

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We evaluated the performance of a vancomycin (VCM) dosing program in predicting dosages necessary to achieve desired serum VCM concentrations in five patients undergoing dialysis. Individual pharmacokinetic parameters were calculated after a first dose of 20mg/kg was administered. Appropriate dosages thereafter were determined using standard pharmacokinetic techniques based on predicted steady-state serum VCM concentrations. The predictive performance of the five patients verified the clinical application of this method. For patients undergoing hemodialysis three times a week, we recommend that VCM treatment be initiated with a first dose of 25mg/kg followed by a maintenance dose of 20mg/kg once a week. We also recommend that hemodialysis and nonhemodialysis clearance be determined to predict larger dosages appropriate for the treatment of patients with severe MRSA.

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A fact-finding questionnaire on the management of infectious complications in patients with acute leukemia, developed by the Supportive Care Committee of the Japan Adult Leukemia Study Group (JALSG), was distributed to 196 steering committees throughout Japan in autumn 2001, with responses by 125 (64%). New quinolones were used by 38% of respondents and polymixin B by 31% for antibacterial prophylaxis, amphotericin B (AMPH-B) by 42% and fluconazole (FLCZ) by 41% for fungal prophylaxis. No prophylaxis was given by 6% for bacterial infection or by 3% for fungal infection. Monotherapy with either cephem or carbapenem was used by 35% for empiric therapy of febrile neutropenia. Overall frequency of use of duotherapy with cephem, carbapenem, or antipseudomonal penicillin plus aminoglycoside was 50%. Vancomycin was used by only 1% as part of initial empiric therapy. Antifungal treatment was added by 51% after 3-4 days of ineffective empiric therapy; FLCZ (66%) was preferred over AMPH-B (28%) in such a scenario. FLCZ was selected by 59% in cases of stable disease, and AMPH-B by 57% in cases of unstable disease as therapy for Candidemia. AMPH-B was selected as therapy for invasive Aspergillosis, but a dose of 0.5-0.7 mg/kg, inadequate for this disease, was used by 44%. Most of the respondents used G-CSF in cases of life-threatening infection among patients with acute myelogenous leukemia (27%), but prophylactic use of G-CSF was common (52%) among patients with acute lymphocytic leukemia. This data should prove helpful in developing guidelines for the management of febrile neutropenia in Japan.

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A dose of 200mg of LVFX twice a day given to relatively elderly pneumococcal pneumonia patients yielded favorable results. Subjects were 5 men and 2 women (mean age 72 yrs) who first consulted a doctors at an average of 4.4 days, after symptom onset, and who all had fever, cough, and expectoration. Fever was alleviated at an average of 3.1 days, after LVFX was initiated. The mean leukocyte count at the first medical examination was 12, 200/μL, improved to 6, 571/μL one week after treatment was started, CRP improved from 10.7mg/dL to 1.27mg/dL. After administration of 200mg of LVFX twice a day, pneumococcus AUC/MIC value became 35, confirming clinical efficacy, with the pharmacokinetic expectation of sufficient efficacy.

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The in vitro and in vivo activity of gatifloxacin against clinical isolated BLNAR strains was examined. The in vitro activity of gatifloxacin against Haemophilus influenzae including ampicillin-resistant isolateswas high potent as well as levofloxacin. Those of cefcapene and cefditoren as the third generation cephem against BLPAR isolates and BLNAR isolates became gradually weaker than against ampicillin-susceptible isolates. In the BLNAR TUH 267 bronchopneumonia mice treated with a drug twice a day for three days, the number of bacteria in the infected tissues of mice treated with gatifloxacin at a dose of 1 mg/kg was less than the detectable limit. In the group of mice treated with cefcapene pivoxil at a dose of 10 mg/kg, the viable counts deceased significantly, compared with those in untreated mice. The present data indicate that gatifloxacin may directly decrease the rectal temperature.

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The purpose of organizing the anti-MRSA drugs TDM study group was to survey how anti-MRSA drugs are actually used in clinical settings and to collect information on the serum or plasma concentration, clinical efficacy and safety of anti-MRSA drugs aimed at the establishment of more suitable dosimetry regimens. Clinical cases in which an antiMRSA drug [arbekacin (ABK), vancomycin (VCM) or teicoplanin (TEIC)] was used and who had undergone TDM during the period from April 1999 to December 2002 at 50 participating medical facilities nationwide, were assessed for clinical efficacy, safety, etc. of the treatment. The total number of cases collected was 596 (479 treated with ABK, 93 with VCM and 24 with TEIC). After examination by the Review Committee for the Authenticity of MRSA Infection, 221, 203, 470 and 461 cases of the ABK treatment group, 42, 37, 86 and 87 cases of the VCM treatment group and 13, 11, 23 and 22 cases of the TEIC treatment group, respectively, were subjected to the analysis of clinical efficacy, bacteriological efficacy and safety based on the occurrence of adverse reactions and safety regarding clinical laboratory tests values. The clinical efficacy rates were 74.7%, 64.3% and 30.8%, the bacteriological efficacy rates were 43.8%, 35.1% and 45.5%, the occurrence of adverse reactions was 5.3%, 5.8% and 13.0% and that of abnormal clinical laboratory test values was 8.7%, 8.0% and 18.2%, for the ABK treatment group, VCM treatment group and TEIC treatment group, respectively. Since the number of cases and background factors differed from group to group, the investigation was performed mainly with the ABK treatment group, which was the largest group. In the ABK treatment group, the first TDM was performed within 3 days after initiation of treatment in 56.9% of the cases and within 5 days after the initiation of treatment in 84.6% of the cases, with the largest number of cases (approximately 1/4 of entire cases) having first TDM performed on day 3 of treatment. The ABK dosing regimen was changed (dose and dosing frequency) in 45.6% of the cases under a 100mg×2/day regimen, which was used in the largest number of cases, and in 25.9% of those under a 200mg×1/day regimen (the main dose). In 77 cases with no change in the dosing regimen, the clinical efficacy rates for the 100mg×2/day regimen and 200mg×1/day regimen were 78.4% and 87.5%, respectively, and the occurrence of adverse reactions was 5.5% and 5.0%, respectively. When these efficacy and safety results were analyzed by the χ² test at the 5% level of significance (two-sided), no significant difference was observed between the ABK 100mg×2/day regimen and the 200mg×1/day regimen.

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