cefteram-pivoxil and Bacterial-Infections

Topics: Adolescent; Adult; Aged; Bacterial Infections; Cefmenoxime; Child; Humans; Microbial Sensitivity Tests; Middle Aged

Topics: Bacteria; Bacterial Infections; Cefmenoxime; Cephalosporins; Humans; Tissue Distribution

Cefteram pivoxil (CFTM-PI) is an oral antibiotic available in powder suspension and tablet formulations indicated in China for the treatment of bacterial infections. Although these 2 formulations are marketed in China, published information regarding their pharmacokinetics and bioequivalence in the Chinese population is not available.. The aim of this study was to compare the pharmacokinetics and bioequivalence of the powder suspension (test) and tablet (reference) formulations of CFTM-PI 100 mg available in China.. This single-dose, randomized-sequence, open-label, 2-period crossover study was performed at the Nanjing First Hospital of Nanjing Medical University. Eligible subjects were healthy male volunteers who were randomly assigned at a 1:1 ratio to receive a single 100-mg dose of the test or reference formulation, followed by a 1-week washout period and administration of the alternate formulation. The study drugs were administered after a 12-hour overnight fast. Plasma was assayed using a high-performance liquid chromatography method. For analysis of pharmacokinetic properties, including C(max), AUC from time 0 (baseline) to 6 hours (AUC(0-6)), and AUC from baseline to infinity (AUC(0-infinity)), blood samples were obtained at intervals over the 6-hour period after study drug administration. The formulations were considered bioequivalent if the log-transformed ratios of C(max) and AUC were within the predetermined equivalence range (80%-125%) as established by the US Food and Drug Administration (FDA). Tolerability was assessed by monitoring vital signs and laboratory tests (hematology, blood biochemistry, hepatic function, and urinalysis), and by questioning subjects about adverse events (AEs).. Twenty-four Chinese male subjects (mean [range] age,24.2 [23-32] years;weight,64.3 [58-67] kg; height, 172 [167-185] cm) enrolled; all completed the study. No period or sequence effect was observed. The 90% CIs for the log-transformed ratios of C(max), AUC(0-6;), and AUC(0-infinity) were 96.5 to 120.1, 95.7 to 110.2, and 96.2 to 110.4, respectively (all, P>0.05). Similar results were found for the data without log-transformation. No AEs occurred or were reported during the study.. In this small study in healthy Chinese adult male volunteers, a single 100-mg dose of the powder-suspension formulation was bioequivalent to a single 100-mg dose of the tablet formulation based on the US FDA's regulatory definition (rate and extent of absorption). Both formulations were well tolerated.

Topics: Administration, Oral; Adult; Bacterial Infections; Cefmenoxime; China; Chromatography, High Pressure Liquid; Cross-Over Studies; Dose-Response Relationship, Drug; Drug Compounding; Drug Tolerance; Follow-Up Studies; Humans; Male; Powders; Reference Values; Tablets; Therapeutic Equivalency

We studied the clinical efficacy and prophylactic effect of Tomiron (cefteram pivoxil; CFTM-PI), a new oral cephalosporin, in the surgical patients. CFTM-PI was administered at a daily dose of 300 or 600 mg after meals. Infectious diseases in 151 patients consisted of infected atheroma, wound infection, subcutaneous abscess, furuncle, phlegmon, mastitis, lymphangitis, periproctal abscess and biliary tract infection. Fifty patients were administered CFTM-PI to prevent secondary wound infection. The clinical efficacy rate was 75.5% in the treatment of infection and 86.0% in the prophylactic use. The clinical efficacy for skin and soft tissue infection was regarded as excellent in 25, good in 74, fair in 17 and poor in 8 out of 124 cases, with a clinical efficacy rate of 79.8%. The eradication rate in 40 cases of monomicro-bial infection was 97.4%, and in 12 cases of polymicrobial infection it was 72.7%. For biliary tract infection, the clinical efficacy was excellent in 1, good in 5, fair in 1 and poor in 1, with a clinical efficacy rate of 75.0%. Adverse effects were observed in 4 (2.0%) of 201 cases: allergic reaction in 3, and sleepiness in 1. Abnormal laboratory findings were observed in 2 cases, but it is not clear if these were due to this drug. These results indicate that Tomiron is a useful oral antimicrobial agent in the treatment and prophylaxis of surgical infection, mainly skin and soft tissue infection.

Topics: Adolescent; Adult; Aged; Bacterial Infections; Cefmenoxime; Connective Tissue Diseases; Female; Humans; Male; Middle Aged; Skin Diseases, Infectious; Surgical Wound Infection

Topics: Adult; Aged; Aged, 80 and over; Ampicillin; Bacterial Infections; Cefmenoxime; Cephalosporins; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Pneumonia

Topics: Adult; Aged; Aged, 80 and over; Bacterial Infections; Cefaclor; Cefmenoxime; Cephalexin; Cephalosporins; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Respiratory Tract Infections

Twenty-six children were treated with cefteram pivoxil (CFTM-PI) and the clinical efficacy and side effects were evaluated. Ages of the patients ranged from 8 months to 9 years. Doses of CFTM-PI ranged 7.5-20.1 mg/kg/day for 4 to 19 days. The twenty-six patients including 10 patients with tonsillitis, 1 pharyngitis, 3 otitis media, 2 scarlet fever, 1 bronchopneumonia, 1 lymphadenitis, 6 urinary tract infections, 1 vaginitis and 1 staphylococcal scalded skin syndrome were evaluated for clinical efficacy. Results were excellent in 11, good in 13, and fair in 2 patients. Out of the 26 patients, one case showed elevated GOT and GPT, and another case showed elevated GOT. The pharmacokinetic study of CFTM-PI was performed in 9 fasting patients whose ages ranged from 2 to 11 years. Serum peak concentrations of CFTM were 0.92 to 1.05 micrograms/ml (mean 0.99 microgram/ml) at 1 to 2 hours after a dose of 1.5 mg/kg each to 3 patients, 1.12 to 1.38 micrograms/ml (mean 1.25 micrograms/ml) after a dose of 3 mg/kg each to 3 patients and 0.66 to 2.1 micrograms/ml (mean 1.17 micrograms/ml) after a dose of 6 mg/kg each to 3 patients. The portions of the drug excreted into urine within 8 hours were 8.9% and 14.7% in 2 patients, each given a dose of 1.5 mg/kg, from 13.0 to 23.1% (mean 18.4%) in 3 patients, each given a dose of 3 mg/kg, and 6.3% and 8.7% in 2 patients, each given a dose of 6 mg/kg.

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male

Cefteram pivoxil (CFTM-PI), in fine granules, was studied in pediatric infections and the results obtained are summarized below. It is concluded that CFTM-PI fine granule is an effective drug for the treatment of pediatric infections. 1. The pharmacokinetics of CFTM-PI fine granules was studied in 7 patients (5 males, 2 females) whose ages ranged from 9 to 15 years. (1) In 2 patients, administered with the drug at a dose of 3 mg/kg in the fasting state, serum peak concentrations of CFTM at 2 hours after administration were 0.66 and 0.53 micrograms/ml, and T 1/2 were 1.40 and 1.32 hours, respectively. Urinary recovery rates in the first 8 hours were relatively low at 5.8 and 10.8%, respectively. (2) In 1 patient, the drug administered at a dose of 6 mg/kg in the fasting state, serum peak concentration of CFTM at 2 hours after administration was 3.0 micrograms/ml, T 1/2 was 2.16 hours, and urinary recovery rate in the first 8 hours was 13.8%. In another 2 patients, CFTM-PI administered at a dose of 6 mg/kg after meal, serum peak concentrations of CFTM at 4 hours after administration were 5.8 and 2.5 micrograms/ml, T 1/2 of the latter was 1.93 hours, and urinary recovery rates in the first 8 hours were 27.0 and 14.4%, respectively. (3) In yet another 2 patients, CFTM-PI tablets was administered at a dose level of 150 mg after meal. Serum peak concentrations of CFTM were 1.7 and 1.6 micrograms/ml at 2 hours and 4 hours after administration, respectively, T 1/2 of the former was 1.38 hours, and urinary recovery rates were 24.1 and 15.5%, respectively. 2. Clinical results CFTM-PI as fine granules was administered to 18 patients, and the following results were obtained. (1) 12 cases (6 males, 6 females) with their ages ranged from 3 months to 12 years were administered with the drug at a dose of 10 mg/kg/day, divided into 3 equal portions. Clinical efficacies were fair in 1 case with bronchopneumonia, good in 3 cases with bronchitis and in 4 cases with tonsillitis/pharyngitis, excellent in 1 and good in another with scarlet fever, and good in 1 and poor in another with urinary tract infection (UTI) (2) Six cases (4 males, 2 females) with their ages were 6 and 7 years were administered with CFTM-PI at a dose of 20 mg/kg/day divided into 3 equal portions. Clinical efficacies were good in 1 case with bronchopneumonia, 2 cases with bronchitis and 3 cases with tonsillitis/pharyngitis.

Topics: Adolescent; Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male

Cefteram pivoxil (CFTM-PI), a newly developed oral cephem antibiotic was administered to treat 16 children with various infections. The results were summarized as follows. 1. The clinical responses were "excellent" in 7, "good" in 5, "fair" in 3 and "poor" in 1, with 75.0% efficacy rate. 2. No side effects and no abnormal laboratory findings were observed.

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male

Pharmacokinetic and clinical studies of cefteram pivoxil (CFTM-PI, T-2588) fine granules in children were performed and the following results were obtained. 1. Peak serum concentrations in 4 children given orally a dose of 3 mg/kg and 2 children given orally a dose of 6 mg/kg after meal were reached in 3 to 4 hours and the concentration curves were dependent on dosage levels. The urinary recovery rates up to 8 hours were 29.7% in children given a dose of 3 mg/kg and 29.7% in children given a dose of 6 mg/kg. 2. Clinical efficacies were evaluated in 38 patients with bacterial infections. Twenty seven patients were given each doses of 3 mg/kg in 3 times a day and other 11 patients each doses of 6 mg/kg in 3 times. Clinical effects of CFTM-PI were excellent in 18, good in 19, fair in 1 case, hence the overall clinical efficacy rate was 97.4%. 3. Bacteriologically, 24 strains of causative organisms were isolated. The overall bacteriological eradication rate was 81.8%. Antimicrobial activities were excellent especially against Streptococcus pyogenes, Streptococcus pneumoniae, and Haemophilus influenzae. 4. As for the side effects, slight loose stools were observed in 2 cases, and in laboratory tests, elevations of GOT and GPT were observed in 1 case and an elevation of eosinophil was observed in 1 case. But no one needed any treatment. 5. CFTM-PI is a useful and safe oral antibiotic for the treatment of bacterial infections in pediatrics.

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male

Clinical evaluations of cefteram pivoxil (CFTM-PI, T-2588) were carried out. The obtained results are summarized as follows. 1. Clinical responses to CFTM-PI of 39 patients with pediatric infections were excellent in 16, good in 21, fair in 1 and poor in 1. The overall efficacy rate was 94.9%. 2. Bacteriologically, eradication rates for 39 isolates presumed to be pathogens were evaluated. The eradication rates obtained were 94.1% in 17 strains of Gram-positive cocci, 90.9% in 22 strains of Gram-negative rods. 3. Side effects observed were diarrhea in 2 patients, diarrhea and abdominal pain in 1, erythema and edema in 1. The incidence was 8.7%. An abnormal value found in clinical laboratory tests was eosinophilia in 1 patient. The results suggested that CFTM-PI might be a very useful and safe drug for the treatment of pediatric infections.

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male

A new oral cephem antibiotic, cefteram pivoxil (CFTM-PI, T-2588), was studied for clinical efficacy in the field of pediatrics. CFTM-PI was given orally to 23 patients with the following acute bacterial infections: 6 cases of acute tonsillitis, 8 of acute bronchitis, 2 of scarlet fever, 4 of bronchopneumonia, 1 of acute otitis media with sinusitis and 2 of urinary tract infections. Clinical results were "excellent" in 8, "good" in 14, "poor" in 1: the efficacy rate was 95.7%. As an adverse reaction, diarrhea was observed in 1 patient. From the above clinical results, it appears that CFTM-PI is a useful antibiotic for the treatment of pediatric patients with various bacterial infections.

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male; Microbial Sensitivity Tests

Bacteriological, pharmacokinetic and clinical studies were done on the effect of cefteram pivoxil (CFTM-PI, T-2588) (10% granules), a new oral cephalosporin, in the field of pediatrics. The results are summarized below. 1. Antibacterial activities Antibacterial activities of CFTM against Staphylococcus aureus and Streptococcus pyogenes were studied comparatively with activities of cefaclor (CCL), cephalexin (CEX) and ampicillin (ABPC). MICs of CFTM against S. aureus were distributed in a range between 0.78 and 12.5 micrograms/ml, with a peak value of 3.13 micrograms/ml, which were similar to MIC ranges of CEX and CCL. MICs of CFTM against all strains of S. pyogenes were less than or equal to 0.025 microgram/ml, which were similar to MIC of ABPC. CFTM was approximately 2 to 3 folds more effective than CCL or CEX. 2. Absorption and excretion. Serum concentrations and urinary excretions of CFTM were determined in doses of 3 mg/kg (non-fasting) and 6 mg/kg (non-fasting and fasting). In non-fasting subjects, peak concentrations of CFTM in serum were dose-dependent and were 1.15-2.3 micrograms/ml and 1.8-3.6 micrograms/ml at 2-3 hours, 0.125-0.78 micrograms/ml and 0.245-0.97 micrograms/ml at 6 hours, respectively, for the 2 dose levels. Serum half-lives were 1.03-2.65 hours for the dose of 3 mg/kg and 1.07-1.83 hours for 6 mg/kg. In fasting subjects, the mean peak serum concentrations were 1.73 micrograms/ml at 2 hours and 1.13 micrograms/ml at 6 hours for the dose of 6 mg/kg. Urinary recovery rates in the first 6 hours varied 5.3-19.2%. 3. Clinical study Clinical efficacies were examined in a total of 41 cases including 9 cases of bacterial pneumonia, 10 cases of bronchitis, 11 cases of tonsillitis, 7 cases of urinary tract infections, 3 cases of scarlet fever and 1 case of otitis media. Clinical efficacies were excellent in 30 cases, good in 10 cases, poor in 1 case, hence the efficacy rate was 97.6%. All of the 28 bacteria identified in these cases were eradicated after CFTM-PI treatments. No noticeable abnormalities were found as side effects. An elevation of eosinophil, an increase of platelet count and elevations of GOT and GPT were observed in 3 patients.

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Male; Microbial Sensitivity Tests

Cefteram pivoxil (CFTM-PI, T-2588), a new oral cephalosporin antibiotic, was evaluated for its safety and efficacy in children. Fifty-three patients with bacterial infections were treated with 8.3 to 21.8 mg/kg/day of CFTM-PI. The drug was very effective (efficacy rate 98.1%) in pharyngitis, otitis media, tracheobronchitis, pneumonia and skin infections. The antibacterial potency was very good against Haemophilus influenzae, Streptococcus pyogenes and Streptococcus pneumoniae, and was comparable with cephalexin against Staphylococcus aureus. No severe adverse reaction was encountered with the CFTM-PI therapy. The data suggest that CFTM-PI is a safe and effective antibiotic when used in children with susceptible bacterial infections.

Topics: Adolescent; Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male; Microbial Sensitivity Tests

Cefteram pivoxil (CFTM-PI) was administered to 37 patients with acute febrile upper or lower respiratory infections and 3 patients with urinary tract infections at 10 mg/kg/day divided into 3 portions. Good clinical effects were observed in all the cases. As for the bacteriological effect, the evaluable 24 strains (60.0%) were eradicated among 43 strains identified in 37 cases with the treatment with CFTM-PI. Only 2 strains were eradicated among 9 strains of Staphylococcus aureus. Among 3 patients with urinary tract infections with Escherichia coli, 2 strains were eradicated from urine after the administration of CFTM-PI. Four cases showed mild diarrhea among 40 cases. It was not clear whether the diarrhea was due to the administration of CFTM-PI.

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male; Microbial Sensitivity Tests

The usefulness of a new cephem antibiotic, cefteram pivoxil (CFTM-PI, T-2588), was evaluated in the field of pediatrics. 1. Thirty-one patients were enrolled in the study. They included 20 boys and 11 girls with ages 8 months to 8 years 7 months. 2. The patients were treated with CFTM-PI at a dose levels ranging 3.0-4.2 mg/kg in 3 divided portions. The administration was done orally for a duration between 3 and 13 days, with a total dose between 27.3 and 130.0 mg/kg. 3. The patients were diagnostically classified into the following categories: 11 with acute pharyngitis, 1 with acute nasopharyngitis, 6 with acute tonsillitis, 9 with acute bronchitis, 2 with scarlet fever, 1 with purulent parotitis and 1 with purulent cervical lymphadenitis. 4. Clinical responses to the treatment were excellent in 14, good in 13, fair in 1 and poor in 3 patients with an overall efficacy rate of 87.1%. 5. Bacteriological responses were as follows: of 29 bacterial strains presumed to be pathogens, 23 were eradicated, 2 unchanged and 4 unknown, with an eradication rate of 92.0%. 6. Neither adverse reactions nor abnormal changes in laboratory test values were observed with the medication in any patients during and after the end of the treatment. None of the patients refused the medication. CFTM-PI was found very effective and safe in treating pediatric infections: it is a useful drug in the field of pediatrics.

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male; Microbial Sensitivity Tests

Cefteram pivoxil (CFTM-PI, T-2588) was administered to pediatric patients with acute infectious diseases, and a summary of the results obtained are as follows. 1. Pharmacokinetic parameters determined in 1 patient appears to be comparable to those of adults. 2. Clinical efficacy was studied on 16 children with acute urinary tract infections, acute upper respiratory infections, acute sinusitis, acute otitis media and acute cervical lymphadenitis. Responses to the treatment were excellent in 7 (43.8%) and good in 9 (56.3%). 3. No adverse reactions were noted in this study.

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male

Laboratory and clinical studies on cefteram pivoxil(cefteram) a new cephem antibiotic, were carried out in the field of pediatrics. The results obtained are summarized as follows: 1. Serum concentrations, urinary concentrations and urinary recovery rates of cefteram (CFTM) were determined upon oral administration after meal of cefteram pivoxil (CFTM-PI) at doses of 3 mg/kg granules in 2 cases and 6 mg/kg granules in 2. Peak serum levels of CFTM were obtained at 3 hours in 2 cases and 4 hours in 2 cases after administration of the drug with a range of 0.74-2.2 micrograms/ml with half-lives of 0.77-3.62 hours. Urinary recovery rates in 8 hours after administration ranged from 9.6-23.0%. 2. MICs of CFTM against 22 clinical isolates (Streptococcus pyogenes 4 strains, Streptococcus pneumoniae 4, Staphylococcus aureus 2, Branhamella catarrhalis 1, Haemophilus influenzae 8, Haemophilus parainfluenzae 1, and Escherichia coli 2) were compared with those of cefaclor (CCL), cephalexin (CEX), and ampicillin (ABPC). The antibacterial activity of CFTM was superior to those of CCL and CEX, and was superior against Gram-negative rods and equal against Gram-positive cocci to those of ABPC. 3. Twenty-six pediatric patients with acute infectious diseases (scarlet fever 3 cases, tonsillitis 7, epiglottitis 1, bronchitis 5, pneumonia 5, urinary tract infection 3, cervical lymphadenitis 2) were treated with CFTM-PI at daily doses of 9.3-15.3 mg/kg t.i.d. as a rule. The efficacy rates were 100% clinically and 70% bacteriologically. 4. Side effects or abnormal laboratory test values were not observed except for an increased platelet count in 1 case.

Topics: Absorption; Bacterial Infections; Cefmenoxime; Child; Drug Evaluation; Female; Humans; Male; Microbial Sensitivity Tests

Cefteram pivoxil (CFTM-PI, T-2588), a new oral cephem antibiotic of ester type, was evaluated for its safety, efficacy and pharmacokinetics. 1. One child, 4 years of age (18 kg body weight), was administered orally 3 mg/kg after meal. The peak serum level of CFTM was 0.78 microgram/ml after 2 hours, and cumulative urinary excretion rate during the first 6 hours was 15.0%. 2. Clinical studies on CFTM-PI were carried out in 17 pediatric patients; 1 with acute pharyngitis, 2 with acute tonsillitis, 1 each with pertussis, acute bronchitis, 2 with broncho-pneumonia, 4 with scarlatina, 3 with acute otitis media, and 1 each with lymphadenitis, acrobystitis and urinary tract infection. Clinical responses were excellent in 9, good in 6, fair in 1, poor in 1, and the overall clinical efficacy rate was 88.2%. 3. Bacteriological efficacy was investigated with 10 strains of 5 species (Streptococcus pyogenes 4, Streptococcus pneumoniae 2, Haemophilus influenzae 2, Enterococcus and Bacteroides 1) isolated from 9 patients. All strains were eradicated. 4. As to adverse reactions, mild diarrhea was observed in 1 patient. But therapy had to be continued without procedure and the diarrhea disappeared after 6 days. No adverse hematological, renal or hepatic effects were noted.

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male

A newly developed cephalosporin, cefteram pivoxil (CFTM-PI, T-2588), was evaluated clinically in 40 patients. A pharmacokinetic study was also performed with 8 patients. CFTM-PI was administered as granules. One patient was given CFTM-PI at a dose of 1.5 mg/kg, each of 3 patients was given the drug at a dose of 3 mg/kg and each of 4 patients at a dose of 6 mg/kg. In most cases, serum concentrations of CFTM were determined at 2, 3, 4, and 6 hours after dosing. Urinary concentrations of CFTM were measured for urinary samples collected during periods of 0-2, 2-4, 4-6 and 6-8 hours after dosing. CFTM was assayed using the disk or the cup method using Klebsiella pneumoniae ATCC 10031 as the test organism. The clinical evaluation was conducted in 40 children including 13 patients of acute tonsillitis, 10 of acute lacunar tonsillitis, 10 of scarlet fever, 2 of acute bronchitis, 2 of pneumonia, and 1 each of pneumonia with enteritis, phlegmon and urinary tract infection. The patients were from 4 months to 13 years old. Daily doses were from 8.7 to 12 mg/kg. After CFTM-PI administration in doses 1.5 mg/kg, 3 mg/kg and 6 mg/kg, peak serum concentrations of CFTM were 0.38 microgram/ml, 0.73-2.25 micrograms/ml and 1.2-2.9 micrograms/ml, respectively, and half-lives were 1.55, 0.95-2.30 and 0.80-2.72 hours, respectively. Urinary excretion rates up to 6 or 8 hours after dosing were 10.8-24.7%. Clinical efficacies of CFTM-PI in 40 patients were "excellent" in 27 children, "good" in 12 children and "fair" in 1 with an efficacy rate of 97.5%. Twenty seven strains of causative organisms, including 15 strains of Streptococcus pyogenes, 1 of Escherichia coli, 1 of Salmonella 04, 6 of Haemophilus influenzae, 1 of Haemophilus parainfluenzae and 3 of Branhamella catarrhalis, were isolated. After treatment all strains except 1 strain of B. catarrhalis (unchanged), Salmonella 04 (unknown) and 1 strain of H. parainfluenzae (unknown) were eradicated. Side effects observed clinically were only 1 case of diarrhea. Eosinophilia was observed in 1 case.

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Humans; Infant

The clinical efficacy and the safety of cefteram pivoxil granule (CFTM-PI, T-2588), a newly prepared drug for pediatric use, were performed. A total of 60 patients with ages between 6 months and 14 years 3 months with pediatric infections were medicated with CFTM-PI at dose levels of 3.2-9.9 mg/kg 3 times daily for 3-11 days. Clinical responses to the drug were excellent in 3 of 3 patients with acute pharyngitis, excellent in 14, good in 5 and poor in 2 of 21 patients with acute purulent tonsillitis, excellent in 1 and good in 2 of 3 patients with acute bronchitis, excellent in 16 and good in 8 of 24 patients with acute pneumonia, excellent in 3 and good in 1 of 4 patients with acute urinary tract infection and excellent in 2 of 2 patients with acute purulent lymphadenitis, hence the overall clinical efficacy rate was 96.5% in a total of 57 patients. Bacteriological responses to the drug were as follows: Eradicated, 8 strains of Streptococcus pyogenes, 3 strains of Streptococcus pneumoniae, 19 strains of Haemophilus influenzae (beta-lactamase positive; 7, beta-lactamase negative; 12), 1 strain of Haemophilus parainfluenzae (beta-lactamase positive) and 4 strains of Escherichia coli (beta-lactamase positive; 1, beta-lactamase negative; 3), decreased, 1 strain of S. pyogenes, hence the eradication rate was 97.2%. No side effects were encountered in any of the patients but for 3 who had diarrhoea and 1 who had loose stool, though these changes were slight. As abnormal laboratory test data, elevation of GOT was noted in 1 case, thrombocytosis and elevation of GPT in another. Also, none of the patients refused or complained of difficulty in intaking of the drug via oral route. In conclusion, CFTM-PI appeared to be a safe and highly effective antibiotic against pediatric infections.

Topics: Adolescent; Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male; Microbial Sensitivity Tests

We have carried out laboratory and clinical studies on cefteram pivoxil (CFTM-PI, T-2588). The results are summarized as follows. CFTM-PI was given through oral administration to 2 children each at dose levels of 1.5 mg/kg, 3 mg/kg and 6 mg/kg. After administration, mean peak serum levels of CFTM obtained for the 3 dose levels were 0.66 +/- 0.01 microgram/ml, 1.26 +/- 1.05 micrograms/ml and 2.28 +/- 0.95 micrograms/ml at 2 hours, respectively, and mean half-lives were 1.07 +/- 0.52 hours, 1.32 +/- 0.76 hours and 2.53 +/- 1.70 hours, respectively. Mean urinary excretion rates of CFTM were 19.0 +/- 4.0%, 9.4 +/- 1.5% and 19.9 +/- 4.0% in the first 8 hours after administration of 1.5 mg/kg, 3 mg/kg, 6 mg/kg, respectively. Treatment with CFTM-PI was made in 36 cases of pediatric bacterial infections including 20 cases of tonsillitis, 3 cases of bronchitis, 6 cases of scarlet fever, 3 cases of UTI and 1 case each of bronchopneumonia, abscess, staphylococcal scalded skin syndrome and vaginitis. Results obtained were excellent in 22 cases, good in 14 cases. No significant side effect due to the drug was observed in any cases.

Topics: Adolescent; Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Male

Cefteram pivoxil (CFTM-PI), the pivaloyloxymethyl ester of cefteram (CFTM) in which aminothiazol was also introduced into the 7 position of cephem nucleus, is a new oral cephem antibiotic. CFTM-PI was absorbed through the intestines and hydrolyzed to CFTM by esterases in the intestinal wall and existed in the body fluids as CFTM. A tablet form of this drug has been released in Japan and now a granular form for pediatric patients has been developed. We have determined MICs of 5 drugs (CFTM, cephalexin (CEX), cefaclor (CCL), ampicillin (ABPC), erythromycin (EM], against stock strains and MICs of 6 drugs (CFTM, CEX, CCL, ABPC, methicillin, cloxacillin) against fresh strains from patients received to CFTM-PI, with an inoculum size of 10(6) cfu/ml. A total of 149 strains included Gram-positive cocci i.e. Staphylococcus aureus (11), Streptococcus pyogenes (85), Streptococcus agalactiae (16) and Streptococcus pneumoniae (4), and Gram-negative rods i.e. Haemophilus influenzae (11), Bordetella pertussis (11), Escherichia coli (9), Proteus mirabilis (1) and Morganella morganii (1). The granular form of CFTM-PI was administered to 9 boys (age: 8 years 3 months approximately 10 years 10 months) to determine serum and urinary concentrations of the drug and its urinary recovery rates using bioassay. Doses of 1.5, 3.0 and 6.0 mg/kg were given orally 30 minutes after meal to 3 boys, respectively. Urinary concentrations and its urinary recovery rates of T-2525A, a main metabolite of CFTM, were determined using high performance liquid chromatography (HPLC). To study clinical and bacteriological effects of this drug, a mean daily dose of 3.3 mg/kg divided 3-4 times a day (3 times: 133 cases, 4 times: 9 cases) was administered for 8 days on the average to a total of 142 cases with pharyngitis (22), tonsillitis (12), acute bronchitis (3), pneumonia (11), pleurisy (1), scarlet fever (28), acute purulent otitis media (16), impetigo (13), abscess (2), purulent lymphadenitis (1) and urinary tract infection (33). Adverse reactions and abnormal effects on laboratory test values attributable to this drug were studied in patients. The results obtained are summarized as follows. 1. With regard to Gram-positive cocci, MICs of CFTM against 11 fresh strains of S. aureus ranged from 3.13 to 6.25 micrograms/ml except for 1 strain, thus CFTM was equally effective to CEX, but less active than the other drugs tested.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Humans; Infant; Microbial Sensitivity Tests

The clinical effectiveness of cefteram pivoxil (CFTM-PI) granule, a new oral cephalosporin, was studied in pediatric patients. The results are summarized as follows. 1. CFTM-PI was given orally to 17 children in daily doses of 9.5 to 31.8 mg/kg in 3 to 4 divided portions for 2 to 10 days. Clinical evaluations were made on 14 patients. Clinical effects of CFTM-PI were excellent in 4, good in 5 of 9 patients with tonsillitis or pharyngitis, excellent in all cases of 2 patients with pneumonia, 1 patient with scarlet fever and 1 patient with pyelonephritis, and fair in 1 patient with purulent cervical lymphadenitis. Overall clinical effects were excellent in 8, good in 5, and fair in 1 with an efficacy rate of 92.9%. 2. No side effects were observed in any of the 17 patients. Hematological tests showed a slight elevation of blood platelet counts in 1 patient. 3. The taste and odor of CFTM-PI granule were well accepted by the children. 4. CFTM-PI is a useful oral antibiotic for the treatment of bacterial infections in pediatrics.

Topics: Bacterial Infections; Cefmenoxime; Child; Child, Preschool; Drug Evaluation; Humans; Infant

Topics: Acetylcholine; Aged; Bacterial Infections; Bile; Biliary Tract Diseases; Cefmenoxime; Chemical Phenomena; Chemistry; Female; Gastrointestinal Motility; Humans; Male; Middle Aged; Ursodeoxycholic Acid

T-2588, the pivaloyloxymethyl ester of T-2525, [6R, 7R]-7-[(z)-2-(2-aminothiazol-4-yl)-2-methoxyiminoacetoamido] -3- [(5-methyl-2H-tetrazol-2-yl)methyl]-3-cephem-4-carboxylic acid, is a new oral cephalosporin. T-2525 had a widely expanded antibacterial spectrum against gram-negative and gram-positive bacteria. T-2525 was more active in vitro than cefaclor, cephalexin, and amoxicillin against members of the family Enterobacteriaceae and Branhamella catarrhalis. Moreover, it exhibited superior in vitro activity against Streptococcus pyogenes, Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae. T-2525 was highly stable to various beta-lactamases, which were classified as Richmond and Sykes types Ia, Ib, Ic, III, IV, and Vc. It had high affinities for the lethal (essential) penicillin-binding proteins of Escherichia coli, Clostridium perfringens, and Bacteroides fragilis. T-2588 had excellent therapeutic effect on systemic infections in mice with various species of gram-negative bacteria, including beta-lactamase-producing bacteria.

Topics: Amoxicillin; Animals; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Bacterial Proteins; beta-Lactamases; Carrier Proteins; Cefaclor; Cefmenoxime; Cephalexin; Cephalosporins; Chemical Phenomena; Chemistry; Hexosyltransferases; Male; Mice; Mice, Inbred ICR; Muramoylpentapeptide Carboxypeptidase; Penicillin-Binding Proteins; Peptidyl Transferases; Protein Binding