[Clinical trials of BRL 25000 (clavulanic acid-amoxicillin) granules on skin and soft tissue infections in the field of pediatrics].
BRL 25000 is a combination of a newly-developed beta-lactamase inhibitor clavulanic acid (CVA) and amoxicillin (AMPC) in the ratio of 1 to 2. The drug, as medium granules, was administered to a total of 92 pediatric patients, ranging in age from 1 month to 13 years and 2 months, with cutaneous/soft tissue infections (70 impetigo, 6 furuncle, 7 phlegmon, 6 abscess and 3 cases of lymphadenitis). It was found subsequently that 2 of the 70 impetigo cases had received topical antibiotic medication and these were excluded from clinical evaluation to give a total of 90 evaluable cases. The daily dosage of BRL 25000 ranged from 23.7 to 75.0 mg/kg, given in 3 or 4 divided doses (average 48.5 mg/kg) and the duration of treatment was for 3 to 13 days (average 6 days). Clinical isolates of S. aureus from the above cases were examined for beta-lactamase production and their susceptibility determined to the 5 antibiotics BRL 25000, AMPC, CVA, cephalexin (CEX) and cefaclor (CCL). The drugs' clinical effects on the various diseases, bacteriological effects and side effects were also studied. At an inoculum of 10(8) cells/ml, major MICs of BRL 25000, AMPC, CVA, CEX and CCL against 71 strains of S. aureus, including beta-lactamase negative ones, were 3.13 mcg/ml, 12.5 mcg/ml, 50 mcg/ml, 12.5 mcg/ml and 12.5 mcg/ml, accounting for 60.6, 38.0, 49.3, 38.0 and 43.7% of the strains respectively, whilst at an inoculum of 10(6) cells/ml, major MICs were 1.56 mcg/ml, 3.13 mcg/ml, 25 mcg/ml, 6.25 mcg/ml and 3.13 mcg/ml, accounting for 57.7, 33.8, 83.1, 50.7 and 54.9%, respectively. It was noted that all drugs tended to show smaller MIC values as the inoculum size was reduced to 10(6) cells/ml and that BRL 25000 showed the most potent antibacterial activity of all 5 drugs.(ABSTRACT TRUNCATED AT 400 WORDS)
D000284:Administration, Oral; D000658:Amoxicillin / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D019980:Amoxicillin-Potassium Clavulanate Combination; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D002969:Clavulanic Acids / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004338:Drug Combinations / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010403:Penicillin Resistance; D012874:Skin Diseases, Infectious / Q000188:drug therapy*; D013211:Staphylococcus aureus / Q000187:drug effects
D000900:Anti-Bacterial Agents; D002969:Clavulanic Acids; D004338:Drug Combinations; D019980:Amoxicillin-Potassium Clavulanate Combination; D000658:Amoxicillin