Laboratory and clinical studies on cefminox in the pediatric field

Laboratory and clinical studies were performed as follows on cefminox (CMNX, MT-141), a new cephamycin antibiotic. Pharmacokinetics Serum concentrations of CMNX were measured in 4 patients given CMNX for prophylactic purpose during cardiac catheterization. In 2 patients given 20 mg/kg of CMNX by intravenous bolus injection, the average of peak serum concentration was 178.9 micrograms/ml at 15 minutes. The mean urinary recoveries in these 2 cases was 66.9% within 6 hours after injection. In 2 patients given 20 mg/kg of this drug by 1 hour drip infusion, the peak serum concentration was obtained at the time drip was completed, and the average value was 68.3 micrograms/ml. Clinical efficacy CMNX was administrated intravenously to 13 patients in dose of 52.9 approximately 96.0 mg/kg t.i.d. or q.i.d. for 4 approximately 7 days; 3 with tonsillitis, 6 with bronchitis, 1 with bronchopneumonia, 1 with UTI, 1 with lymphadenitis and 1 with enterocolitis. The overall efficacy rate was 92.3%, i.e., efficacy was excellent in 12, and poor in 1. Bacteriological efficacy was excellent, i.e., 3 of 3 strains disappeared. Side effects were observed in 3 cases, i.e., 1 case of eruption, 1 case of diarrhea and 1 case of transient eosinophilia. The above results suggest that CMNX is a useful antibiotic for treating pediatric bacterial infections.     

Clinical experience with cefminox in the pediatric field

Cefminox (CMNX, MT-141) was given intravenously to 20 children with the following acute bacterial infections; 10 cases of bronchopneumonia, 4 cases of urinary tract infection, 2 cases of staphylococcal scalded skin syndrome, each 1 case of acute pharyngitis, acute tonsillitis, purulent cervical lymphadenitis and acute tonsillitis, and pleuritis. Good clinical responses were obtained in 18 patients out of 20 patients and bacteriological effectiveness in 13 strains out of 14 strains. No side effect was observed except for 1 case with diarrhea and 1 case with slight elevation of GOT and GPT. From the above clinical results, it is apparent that CMNX is a useful antibiotic for treating pediatric patients with various kinds of bacterial infections.     

Clinical studies on cefminox in the field of pediatrics

A new antibiotic of cephamycin group, cefminox (CMNX, MT-141), was evaluated clinically in the treatment of bacterial infections in children. The following results were obtained. One case of lacunar tonsillitis (due to H. influenzae) and 5 cases of urinary tract infections (due to E. coli in 2 cases, mixed infection due to E. coli and E. faecalis in 1 case, due to K. pneumoniae in 1 case and causative organism was unknown in 1 case) were treated intravenously with CMNX at daily doses ranging from 58.1 to 122.7 mg/kg in 3 divided doses. One case in which the treatment was discontinued after 1 day because of rashes was excluded from assessment of efficacy. Among the remaining 5 cases, CMNX was found ineffective for 1 case of mixed infection due to E. coli and E. faecalis. However, in all of the other 4 cases excellent results were obtained. As side effects, rashes developed in 1 case and slight elevation in GOT in 1 case out of 6 cases. Blood levels following bolus intravenous injection of 20 mg/kg of CMNX were 68, 45, 27, 10.2 and 3.1 micrograms/ml at 1/2, 1, 2, 4 and 6 hours, respectively, with T 1/2 of 1.27 hours. The urinary recovery rate within the first 6 hours was 78.6%.     

Laboratory and clinical studies of cefminox in the pediatric field

The authors have carried out the pharmacokinetic and clinical studies of cefminox (CMNX, MT-141). The results were as follows: CMNX was given by intravenous drip infusion for 1 hour at a dose of 20 mg/kg b.w. to 2 children. The serum levels of CMNX were 103.02 micrograms/ml and 77.73 micrograms/ml at 1 hour after drip infusion, and the levels at 7 hours were 4.39 micrograms/ml and 4.19 micrograms/ml, respectively. The half life times were 1.20 hours and 1.32 hours, respectively. CSF concentrations of CMNX at 1 hour after drip infusion of a dose of 50 mg/kg in 3 patients with aseptic meningitis were 1.68 micrograms/ml (d.i. for 30 minutes), less than or equal to 0.25 micrograms/ml (d.i. for 1 hour) and 0.51 micrograms/ml (d.i. for 1 hour), respectively. CSF/serum ratios were 1.1% and 0.6%. Clinical efficacy was evaluated in 10 cases with purulent tonsillitis (3 cases), pneumonia (3 cases), pyelonephritis (1 case) and enteritis (3 cases). Excellent and good responses were obtained in all cases. Bacteriological response in the form of eradication was noted 8 of 9 cases. No side effects were observed.     

Clinical studies on cefminox in the field of obstetrics and gynecology

Clinical and laboratory studies on cefminox (CMNX, MT-141), a new injectable cephamycin antibiotic, were made in the field of obstetrics and gynecology, and following results were obtained. In the clinical trial, 12 cases were treated with CMNX given by intravenous drip infusion. The results were excellent in 2 cases, good in 8 cases and poor in 2 cases. The effectiveness rate was 83.3%. No side effect was recognized. No significant changes of laboratory findings were noticed.     

Clinical studies on cefmenoxime in pediatric field

A new cephalosporin antibiotic, cefmenoxime (CMX) was administered to 22 patients aged 5 days to 8 years, and who had moderate or severe pediatric infections, to examine its clinical effect. The infections were 3 of acute bronchitis, 2 cases of asthmatic bronchitis, 6 of acute pneumonia, 1 of Mycoplasma pneumonia, 2 of sepsis (1 accompanied with pneumonia), 3 of vacterial meningitis, 2 of urinary tract infection, 1 of acute appendicitis, 1 of aseptic meningitis and 1 of fever of undetermined origin. The drug was administered by one shot intravenous injection 4 times daily at the dose of 40 approximately 200 mg/kg/day. The drug was administered for 3 approximately 15 days, the total dosage administered being 0.7 approximately 43.5 g. Clinically, excellent, good and fair response was obtained in 2, 11 and 4 cases, respectively, the drug being effective in all cases excluding the 5 cases in which judgement was unknown. The 6 strains of bacteria isolated from the lesion as the assumed causative bacteria (1 strain of S. pneumoniae, 2 of H. influenzae, 2 of E. coli, 1 of K. pneumoniae) were all eradicated after drug administration. No notable side effects were produced.     

Clinical studies on aspoxicillin in the pediatric field

Studies on efficacy and safety of aspoxicillin (ASPC) were carried out to 14 cases of pediatric infections, and the following results were obtained. Clinical efficacy of ASPC to 10 respiratory infections, 1 urinary tract infection and 1 otitis media was excellent in 6 cases (50%) and good in 6 cases (50%). The efficacy rate was 100%. Bacteriological effect of ASPC to 6 cases which detected the causative organisms (S. aureus, E. faecalis, H. influenzae and P. mirabilis) was eliminate in 3 cases (50%) and replace in 3 cases (50%). The bacterial eliminated rate was 100%. Side effects of ASPC to 14 administered cases were observed in 2 cases, that were urticaria in 1 case and elevation of GOT in 1 case. From the above results, it was concluded that ASPC was the useful and secure antibiotic drug for treatment of infections in pediatric field.     

Clinical studies on ceftazidime in the pediatric field

Ceftazidime ( CAZ ) is a newly developed cephalosporin. Clinical studies on this drug was carried out and the results were as follows. Twenty-nine patients (acute purulent tonsillitis 2, acute bronchitis 1, pneumonia 15, acute purulent lymphadenitis 2, pyoderma 1, skin abscess 2 and urinary tract infection 6) were treated with CAZ in doses of 42-1 mg/kg (mean 59 mg/kg) divided 2-3 times per day for 3-10 days (mean 5.7 days) intravenously. The overall efficacy rate was 96.6%. As to adverse reaction, drug fever was observed in 1 patient. Abnormal laboratory data were noted in 4 cases (elevation of serum GOT, GPT and BUN in 1, elevation of serum GOT and GPT in 1, elevation of BUN in 1 and leukopenia in 1).     

Clinical studies on cefmenoxime in the pediatric field

Clinical studies in the field of pediatrics have been carried out with cefmenoxime (CMX), a new cephalosporin antibiotic and the following results were obtained. 1. CMX was administered intravenously by drip infusion in 23 patients with infectious diseases. These diseases consist of 10 pneumonia, 1 bronchitis, 6 upper respiratory tract infections, 2 acute pyelitis, 3 other urinary tract infections and 1 Douglas abscess. CMX was effective in all cases except 1 case of pneumonia with pyothorax. 2. No side effects have been observed in all cases. As for abnormal laboratory findings, 2 cases of eosinophilia, slight elevations of GOT in 3 cases and GPT in 2 cases were seen.     

Clinical studies on cefdinir granules in pediatric field

Cefdinir (CFDN, FK482) granules, a new oral antibiotic for children, were given to children with infections. The results obtained are summarized as follows. 1. The plasma level of CFDN peaked at 0.38-0.88 microgram/ml in 2-3 hours after administration of the drug at a dose of 3 mg/kg. Meanwhile, the plasma level peaked at 1.85 micrograms/ml in 3 hours after administration of 6 mg/kg. The plasma level was higher in the 6 mg/kg group than that in the 3 mg/kg group, thus a dose response was clearly observed. 2. The 8 hour urinary excretion accounted for 10.3-17.4% of administered amount of the drug in children with 3-6 mg/kg dosage. 3. CFDN granules were administered to a total of 42 children with upper or lower airway infections or with urinary tract infections at daily doses of 9.0-20.7 mg/kg in 3 divided portions. The clinical efficacy was "excellent" in 28 patients, "good" in 13, and "fair" in 1, hence an efficacy rate of 97.6% was obtained. 4. Bacteria identified from various diseases were 29 strains of 9 species, and the eradication rate was 82.8%. 5. No. side effects were noted in any of the children. Laboratory test results showed an abnormality in 1 case each with a rise of platelet count and eosinophilia.     

Clinical studies on ceftriaxone in the pediatric field

Clinical studies on ceftriaxone (Ro 13-9904, CTRX) were carried out and the results were as follows: Twelve patients (acute purulent tonsillitis 1, pneumonia 6, urinary tract infection 5) were treated with CTRX, in doses of 21-48 mg/kg divided 2 times per day for 3.5-8 days intravenously. The overall efficacy rate was 100%. No adverse reactions were observed. No abnormal laboratory data were noted.     

Clinical studies of cefixime in pediatric field

Pharmacokinetic and clinical studies of cefixime (CFIX) in children were done and the following results were obtained. Serum and urinary concentrations of CFIX were determined in 6 children aged 5 to 14 years given single doses of 1.5 or 6.0 mg/kg. Mean serum concentrations peaked at 4 hours after the administration of either 1.5 or 6.0 mg/kg, and respective peak values were 0.71 and 4.46 micrograms/ml. Biological half-lives for the low and the high doses were 5.28 and 4.45 hours, respectively. The 12-hours urinary recovery ranged from 7.0 to 13.8% after administration of 1.5 mg/kg, and the 8-hours urinary recovery was 18.1% after administration of 6.0 mg/kg. Therapeutic responses were recorded as excellent or good in 43 (97.7%) of the children, comprising 13 with tonsillitis and 31 with scarlet fever. The microbiological effectiveness of CFIX on identified pathogens comprising 29 strains of S. pyogenes and 2 strains of S. aureus was satisfactory as evidence by a high eradication rate of 93.5%. No clinical side effects were observed. Abnormal laboratory findings were elevation of GOT and/or GPT in 4 patients and eosinophilia in 1 patient. In conclusion, CFIX was found to be efficacious and safe for the treatment of bacterial infections in children.     

Fundamental and clinical studies on cefminox in the field of pediatrics

Cefminox (CMNX, MT-141) is a new injectable cephamycin antibiotic, which was studied for its antibacterial activity, absorption and excretion after administration and clinical efficacy of patients with infections. The following results were obtained. Antibacterial activity The antibacterial activity of CMNX against 19 clinical isolates consisting of 11 species made the results that its activity against E. coli, P. vulgaris and C. jejuni was superior to CMZ and CEZ. Concentration in serum and urine CMNX was given intravenously to 3 groups at 20 mg/kg by one shot (2 cases), 40 mg/kg by one shot (2 cases) and 40 mg/kg by 1 hour drip infusion (1 case). The half-lives were between 1.15 to 1.80 hours. We obtained over 70% of its excretion to urine within 6 hours after injection. Clinical efficacy Clinical evaluation was made on a total of 18 patients with various infections, 11 of whom had underlying diseases. The result was excellent in 1 case, good in 11 cases, fair in 2 cases and poor in 4 cases, and the effective rate was 66.7%. Side effect Clinical and laboratory abnormal findings related to CMNX were not found. It is concluded that CMNX seems to be effective and safetive antibiotic in the field of pediatrics.     

Clinical studies on sultamicillin fine granule in pediatric field

Pharmacokinetics, safety and effects on bacterial infection of sultamicillin (SBTPC) fine granule were evaluated in 17 children. The results obtained are summarized as follows. 1. Pharmacokinetics in 3 children receiving a single dose of 10 mg per kg body weight were evaluated. The half-life of ampicillin (ABPC) was 1.38 +/- 0.14 hours and that of sulbactam was 0.93 +/- 0.26 hour. 2. Fourteen cases, including 7 tonsillitis, 2 pharyngitis, 2 bronchitis, and 1 each of cystitis, scarlet fever and cellulitis were treated with SBTPC fine granule. The clinical efficacy rate was 100%. 3. Bacteriological efficacies classified by causative organisms were evaluated in 5 children. Staphylococcus aureus was responsible in 3 cases, Streptococcus pyogenes in 1 case, Escherichia coli and Proteus mirabilis in 1 case. Eradication rate was 100%. SBTPC was more active than ABPC against ABPC-resistant strains and almost equal to or more active than cephalexin or cefaclor. 4. The only abnormal laboratory test value observed was eosinophilia in 2 children. No side effects were recorded. From the above results it is concluded that SBTPC fine granule is one of first choices of effective, useful and safe antibiotics for the treatment of infections in pediatric field.     

Clinical studies of cefpodoxime proxetil in pediatric field

Clinical studies of cefpodoxime proxetil (CPDX-PR), a new cephem antibiotic, were carried out in 60 patients in the pediatric field. The overall efficacy rate on 54 patients with various infections was 98.1%, and few side effects, all of them very mild, were developed in 6 of 60 patients (10%). It was concluded that CPDX-PR was one of the most useful antibiotics in the pediatric field because of the high efficacy rate and the safety.     

Clinical studies of meropenem in pediatric field]

We have carried out clinical studies on meropenem (MEPM, SM-7338), the results are summarized as follows. Treatment with MEPM was made in 13 cases of pediatric bacterial infections including 9 cases of pneumonia and 2 cases of colitis and 1 case each of purulent tonsillitis, and pharyngitis. Results obtained were excellent in 10 cases, good in 3 cases. No significant side effects due to the drug were observed in any cases, except in 1 case each of eosinophilia, elevated gamma-GTP, elevated total bilirubin and elevated GPT.     

Clinical studies of cefodizime in the pediatric field

Cefodizime (CDZM, THR-221) was evaluated for its pharmacokinetics, safety and efficacy in 30 pediatric patients with bacterial infections. The following results were obtained. 1. The pharmacokinetics of CDZM in 6 children were investigated with a dose level of 20 mg/kg via intravenous injection. Mean serum half-lives (T 1/2 beta) of the drug were 120.9 minutes (HPLC) and 115.6 minutes (bioassay). In 8 hours after administration of CDZM, urinary excretion rates were 74.7% (HPLC) and 75.0% (bioassay). 2. The clinical efficacies of CDZM were studied in 29 pediatric patients, comprising 22 with respiratory tract infections, 2 with urinary tract infections, 2 with enteritis, 2 with lymphadenitis and 1 with gingivitis. The clinical efficacies were excellent in 13, good in 13 and fair in 3, with an efficacy rate of 89.7%. 3. The eradication rate for pathogens identified in 7 pediatric patients was 60% (6/10). The clinical efficacy rate in cases where pathogens were identified was 100% in terms of excellent+ good evaluations. 4. Only one case of mild diarrhea was observed as a side effect associated with CDZM. Laboratory tests revealed abnormal value of slightly elevated eosinophil in 3 cases. The data suggested that CDZM is a safe and effective injectable antibiotic for the treatment of infections in children.     

Clinical studies of flomoxef in the pediatric field

Flomoxef (FMOX, 6315-S) was evaluated pharmacologically and clinically in its application to bacterial infections in children. 1. Pharmacokinetics: A bullous intravenous injection of FMOX at 20 mg/kg body weight gave a peak serum concentration of 114.6 +/- 34.4 micrograms/ml in 1 minute after the injection and T1/2 of beta-phase was 0.86 +/- 0.15 hours. 2. Bacteriological effectiveness: MIC of FMOX against Staphylococcus aureus except resistant strains (10(6) cells/ml) was below 0.39 micrograms/ml and against Haemophilus influenzae, Escherichia coli and Klebsiella pneumoniae (10(6) cells/ml) were below 0.78 microgram/ml. 3. Clinical effectiveness: Clinical effectiveness of FMOX was excellent in 14 cases, good in 2 cases and fairly good in 1 case among 17 cases of bacterial infections examined. An increase in eosinophilic leukocytes was observed in 1 case but no other clinical adverse effects were detected. These findings indicate that FMOX is a useful and safe antibiotic as a first choice against bacterial infections in children.     

Clinical studies of cefuzonam in the pediatric field

Analysis on serum concentrations of cefuzonam (CZON, L-105) in 7 children who received different doses of CZON revealed a dose-response relationship. The half-life of the drug in blood was 0.90 hour. CZON was administered to 17 pediatric patients with bacterial infections. The clinical efficacy rate was 88% (15/17), and the eradication rate of pathogens was 80% (4/5). Only one case of mild diarrhea (1/17) was observed as a side effect associated with CZON.     

Clinical studies on sulbactam/cefoperazone in the pediatric field

Sulbactam, a new beta-lactamase inhibitor, in combination with cefoperazone was administered to 18 pediatric patients, 7 months to 10 years 6 months of age, at a daily dose of 56-320 mg/kg divided into 4 times by intravenous bolus infusion for 3 to 11 days, and the sum of 2.6-74.0 g of the drug was given. A total of 18 cases comprised 8 with RTI, 1 with gastric tract infection, 4 with UTI and 5 with sepsis (suspected). Clinical efficacy was excellent in 10 cases, good in 3 cases, fair in 1 case and poor in 4 cases, and efficacy rate was 72.2%. Out of 8 strains (1 of S. aureus, 1 of P. aeruginosa, 1 of Salmonella subgenus I, 2 of E. coli, 2 of P. mirabilis and 1 of K. pneumoniae), possible causative organisms isolated before the treatment, 6 strains were disappeared, 1 strain of K. pneumoniae persisted, and 1 strain of P. aeruginosa was replaced by S. aureus. Diarrhea was noted in 1 case as subjective side effect, and as abnormal laboratory findings, GOT and GPT elevations in 1 case, GPT elevation in 1 case and eosinophil elevation in 1 case were observed.