s-1108 and Urinary-Tract-Infections

We aimed to reveal the usefulness of and problematic points with the Criteria for evaluation of clinical efficacy of antimicrobial agents on urinary tract infection (draft fourth edition) proposed by the UTI Subcommittee of the Clinical Evaluation Guidelines Committee, Japan Society of Chemotherapy, for evaluating antimicrobial agents for complicated urinary tract infections. We conducted a multicenter trial involving 159 patients with complicated urinary tract infections without indwelling urinary catheters. The antimicrobial agents used were cefcapene pivoxil and levofloxacin. "Early evaluation" took place the day after completion of 7 days of therapy; "late evaluation" took place 5-9 days after the end of treatment, and "follow-up evaluation" was done 4-6 weeks after treatment. In the early evaluation, overall clinical efficacy was judged as excellent in 52.9% of the patients, moderate in 26.1%, and poor in 21.0%, and the bacteriological response was judged as "eradicated" for 86.4% of the 198 bacterial strains isolated. Of 96 patients included in the "late evaluation" category in accordance with the draft fourth edition, the clinical outcome was judged as "cured" in 68.4% and the microbiological outcome was judged as "eradicated" in 59.4%. These rates may be low, because 25 patients in whom clinical efficacy was evaluated as "poor" at the end of treatment were separately classified as "failed" at the late evaluation. Of the 49 patients with an excellent clinical response at the end of treatment, symptoms were exacerbated in 18 at the follow-up evaluation. Overall, the draft fourth edition, with some modifications of the third edition criteria, such as the addition of a follow-up evaluation 7 days after the cessation of drug administration, has the potential to play a role in the international standards for evaluating antimicrobial drug efficacy for complicated urinary tract infections.

Topics: Adult; Aged; Aged, 80 and over; Amdinocillin Pivoxil; Anti-Infective Agents, Urinary; Cephalosporins; Female; Humans; Levofloxacin; Male; Middle Aged; Ofloxacin; Treatment Outcome; Urinary Tract Infections

We aimed to reveal the usefulness of and problematic points with the Criteria for evaluation of clinical efficacy of antimicrobial agents on urinary tract infection (draft fourth edition) proposed by the UTI Subcommittee of the Clinical Evaluation Guidelines Committee, Japan Society of Chemotherapy, for evaluating antimicrobial agents for complicated urinary tract infections. We conducted a multicenter trial involving 159 patients with complicated urinary tract infections without indwelling urinary catheters. The antimicrobial agents used were cefcapene pivoxil and levofloxacin. "Early evaluation" took place the day after completion of 7 days of therapy; "late evaluation" took place 5-9 days after the end of treatment, and "follow-up evaluation" was done 4-6 weeks after treatment. In the early evaluation, overall clinical efficacy was judged as excellent in 52.9% of the patients, moderate in 26.1%, and poor in 21.0%, and the bacteriological response was judged as "eradicated" for 86.4% of the 198 bacterial strains isolated. Of 96 patients included in the "late evaluation" category in accordance with the draft fourth edition, the clinical outcome was judged as "cured" in 68.4% and the microbiological outcome was judged as "eradicated" in 59.4%. These rates may be low, because 25 patients in whom clinical efficacy was evaluated as "poor" at the end of treatment were separately classified as "failed" at the late evaluation. Of the 49 patients with an excellent clinical response at the end of treatment, symptoms were exacerbated in 18 at the follow-up evaluation. Overall, the draft fourth edition, with some modifications of the third edition criteria, such as the addition of a follow-up evaluation 7 days after the cessation of drug administration, has the potential to play a role in the international standards for evaluating antimicrobial drug efficacy for complicated urinary tract infections.

Topics: Adult; Aged; Aged, 80 and over; Amdinocillin Pivoxil; Anti-Infective Agents, Urinary; Cephalosporins; Female; Humans; Levofloxacin; Male; Middle Aged; Ofloxacin; Treatment Outcome; Urinary Tract Infections

We studied the clinical use of S-1108 granules in the pediatric field. The results are summarized as follows. 1. S-1108 was administered orally at doses ranging 6.85 and 17.6 mg/kg/day t.i.d. to 9 patients, including 5 cases of pharyngitis and 1 case each of lacunar tonsillitis, bronchitis, pneumonia and urinary tract infection. Clinical efficacies were excellent in 4 cases and good in 5 cases, hence an efficacy rate of 100% was obtained. 2. Haemophilus influenzae, Haemophilus parainfluenzae (2 strains each) and Streptococcus pyogenes, Staphylococcus aureus, Escherichia coli and Enterococcus faecalis (1 strain each) were identified in these cases. Seven of the 8 strains were eliminated upon treatment and the other strain was decreased, hence an eradication rate of 87.5% was obtained. 3. Side effects observed were 1 case each of soft stools and diarrhea. As an abnormal laboratory test result, an increase in GPT level was observed. 4. No refusal of the drug occurred. 5. From the above results, we consider that this drug would be a useful new oral antibiotic for the pediatric field.

Topics: Administration, Oral; Cephalosporins; Child; Child, Preschool; Diarrhea; Female; Humans; Infant; Male; Prodrugs; Respiratory Tract Infections; Urinary Tract Infections

We have evaluated S-1108 fine granules for therapeutic effectiveness in children. The results are summarized as follows. 1. A clinical study was performed with 16 children with infections, including 8 with acute tonsillitis, 3 with acute pharyngitis, 2 with scarlet fever, 1 each with acute bronchitis, pertussis and urinary tract infection. Doses ranging from 8.8 to 10.6 mg/kg body weights were given in 3 divided portions. Durations of treatment ranged from 2 to 15 days. The therapeutic responses were considered "excellent" in 1 and "good" in 13, with an efficacy rate of 87.5%, and the bacteriological eradication rate was 91%. 2. No adverse reactions were observed. In laboratory tests, eosinophilia was observed in one patient. It was concluded the S-1108 was promising drug for the treatment of bacterial infections in children.

Topics: Administration, Oral; Cephalosporins; Child; Child, Preschool; Female; Humans; Male; Prodrugs; Respiratory Tract Infections; Urinary Tract Infections

Clinical studies of S-1108, a new oral cephem, in pediatric patients were conducted and results are summarized below. 1) Clinical effects of S-1108 against 18 cases of bacterial infections were excellent in 5 cases, good in 10 cases, fair in 1 case and poor in 2 cases, thus the clinical efficacy rates was 83.3%. 2) Bacteriological effects were evaluated in 16 strains. The elimination rate was 100%. 3) No adverse effects nor abnormal laboratory test results were observed in any of the cases.

Topics: Administration, Oral; Adolescent; Cephalosporins; Child; Child, Preschool; Female; Humans; Infant; Male; Prodrugs; Respiratory Tract Infections; Urinary Tract Infections

Pivoxil-containing cephalosporins can result in symptomatic hypocarnitinemia in children. We herein report a case of an 85-year-old man at risk of carnitine deficiency who developed relapsing symptomatic hypoglycemia after treatment with cefcapene pivoxil for urinary tract infection. On admission, laboratory tests showed low blood carnitine concentrations with low normal blood ketone levels. The patient was successfully treated by the oral administration of levocarnitine and dietary modification, including aggressive consumption of meat and dairy products, and remained symptom-free for nine months after the correction of carnitine concentrations. Healthcare providers should be cautious when prescribing pivoxil-containing antimicrobials to patients at high risk of hypocarnitinemia.

Topics: Administration, Oral; Aged, 80 and over; Blood Glucose; Cardiomyopathies; Carnitine; Cephalosporins; Humans; Hyperammonemia; Hypoglycemia; Male; Muscular Diseases; Recurrence; Urinary Tract Infections

Topics: Bacterial Infections; Cephalosporins; Child; Community-Acquired Infections; Humans; Prodrugs; Skin Diseases; Urinary Tract Infections

We performed laboratory and clinical evaluation of S-1108 granules, a new oral cephalosporin antibiotic, in the pediatric field. 1. Pharmacokinetics of S-1108 was examined with 6 patients, at a dose of 4 mg/kg that was orally ingested 30 minutes after meal. Mean plasma concentrations at 30 minutes, 1, 2, 4, 6 and 8 hours after dose were 0.35, 0.63, 0.86, 0.75, 0.37 and 0.09 microgram/ml, respectively, with a half life of 1.14 hours. The urinary recovery rate in the first 8 hours was 25.5%. 2. The clinical efficacy of S-1108 was evaluated in 31 patients with various infectious diseases. S-1108 was administered at doses ranging 2 to 4.2 mg/kg/dosage, 3 times a day for 1/3 to 10 days. Clinical effects were excellent in 19, good in 12, with an efficacy rate of 100%. Bacteriologically, all causative organisms except two of Staphylococcus aureus and Haemophilus influenzae were eradicated, with an eradication rate of 80%. As an adverse reaction, mild diarrhea was noted in 2 patients. Slight elevations of GOT and/or GPT were noted in 2 patients. Only 1 child had difficulty ingesting the antibiotic preparation. From the above results, we have concluded that S-1108 is a highly effective and safe for patients with various infectious diseases in the pediatric fields.

Topics: Absorption; Alanine Transaminase; Aspartate Aminotransferases; Bacteria; Bacterial Infections; Cephalosporins; Child; Child, Preschool; Diarrhea; Drug Evaluation; Female; Humans; Infant; Male; Respiratory Tract Infections; Urinary Tract Infections

We administered S-1108 to 16 children with ages ranging from 7 month to 15 years at doses between 1.8 and 6.0 mg/kg x 3/day for 3 to 13 days. We evaluated the efficacy and safety of S-1108 in 11 children with respiratory tract infections, 3 urinary tract infections, and 2 skin infections. The efficacy rate of S-1108 was 100% and bacteriological eradication rate was 83.3%. No adverse effects were observed. These results suggested that S-1108 could be used safely in children.

Topics: Adolescent; Bacteria; Bacterial Infections; Cephalosporins; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Respiratory Tract Infections; Skin Diseases, Bacterial; Urinary Tract Infections

A new oral cephem antibiotic, S-1108, was evaluated for its clinical efficacy and safety in children. S-1108 was effective in 95% of the 59 examined cases of respiratory, middle ear, skin and urinary tract infections. S-1108 was highly effective in infections of Streptococcus pyogenes, Haemophilus influenzae and Escherichia coli, but was less effective in penicillin-resistant Streptococcus pneumoniae and Staphylococcus aureus infections. The serum half-life was 1.26 +/- 0.36 hours upon after meal administration of 4 mg/kg. No severe adverse reaction was encountered. From these data, S-1108 appears to be safe and effective in children with susceptible bacterial infections.

Topics: Bacterial Infections; Cephalosporins; Child; Child, Preschool; Drug Evaluation; Escherichia coli Infections; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Infant; Male; Respiratory Tract Infections; Streptococcal Infections; Streptococcus pyogenes; Urinary Tract Infections

Laboratory and Clinical Studies on S-1108, a new oral cephem antibiotic, were carried out to evaluate its usefulness at a dose between 2 and 4 mg/kg a day for 7 to 14 days in the pediatric field. 1) Pharmacokinetic studies S-1108 at a dose of 2 mg/kg was administered to evaluate the pharmacokinetic parameters in 1 subject. Cmax, T1/2 and AUC were 0.69 hour, 1.42 hours and 2.15 micrograms.hr/ml, respectively. 2) Antimicrobial activities MICs against various clinically isolated organisms (Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Branhamella catarrhalis, Escherichia coli and Haemophilus influenzae) were determined. The MIC values of S-1006 were similar to those of cefteram, the MICs against S. pyogenes, and H. influenzae were < or = 0.025 and 0.10 microgram/ml, respectively. 3) Clinical studies S-1108 was administered to patients with various pediatrics infections in 34 cases (upper respiratory tract infections: 12 cases, lower respiratory tract infections: 5 cases, urinary tract infections: 9 cases, skin and soft tissue infection: 6 cases, otitis media: 2 cases). Clinical efficacy rate was evaluated according to "Standard of clinical evaluation in pediatrics field". The responses were all good or excellent. 4) Side reactions There were no serious adverse reactions in any cases. The above results suggest that S-1108 is potent effective and safe agent in the pediatric field at a dose between 2-4 mg/kg (t.i.d.) a day.

Topics: Bacteria; Bacterial Infections; Cephalosporins; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Respiratory Tract Infections; Urinary Tract Infections