CLINICAL STUDY OF CEFPODOXIME PROXETIL DRY SYRUP FOR SKIN AND SOFT TISSUE INFECTIONS IN THE FIELD OF PEDIATRICS

Concurrently with administering a newly developed cephem derivative antibiotic (CEP), cefpodoxime proxetil (CPDX-PR, CS-807) dry syrup, to children with skin and soft tissue infections, activities of 7 drugs against a group of microorganisms were tested. The drugs tested included 4 drugs of the cephem group, R-3746, a Na-salt form of CPDX, cefaclor (CCL), cephalexin (CEX) and cefadroxil (CDX), and 3 drugs of the penicillin group, ampicillin (ABPC), methicillin (DMPPC) and cloxacillin (MCIPC). The bacterial strains tested were 71 strains of Staphylococcus aureus and 1 strain of Streptococcus pyogenes, all isolated from the above cases of pediatric infections. Inoculum sizes used in these tests were 106 and 108 cfu/ml. Ages of children in those cases to which the drug was administered ranged from 2 months to 15 years. A total of 66 cases were treated, including 60 cases of impetigo, 5 cases of subcutaneous abscess and 1 case of phlegmon. The drug was administered for an average of 6 days with a daily average dose level of 9.4 mg/kg divided into 3 doses except 1 case where a twice daily dose regimen was used. Clinical and bacteriological effects were examined, and the occurrence of adverse reactions and abnormal laboratory test results were recorded. The results of these tests are summarized below. 1. The activity test for R-3746 (Na-salt of CPDX) against 71 strains of S. aureus performed at an inoculum level of 108 cfu/ml showed 2 peaks of MIC values, one in a range of 1.56 to 6.25 μg/ml and the other higher than 100 μg/ml. The most prevalent MIC value was 3.13 μg/ml with MIC against 51 strains or 71.8% of the strains tested showing this value, and MIC values of 25 μg/ml or higher were obtained for 13 strains or 18.3% of the strains tested. The MIC80 was 6.25 μg/ml. Thus, R-3746 showed an antibacterial activity slightly weaker than MCIPC and DMPPC but similar to CCL, CEX and CDX. MIC values obtained at an inoculum level of 106 cfu/ml also had 2 peaks, one in a range of 1.56 to 3.13 μg/ml and the other higher than 25 μg/ml. Strains against which R-3746 had the MIC value of 3.13 μg/ml were the most numerous with 47 strains or 66.2%, and strains against which the MIC value of higher than 25 μg/ml was obtained were next with 13 strains or 18.3%. The MIC80 with 106 cfu, ml was 3.13 μg/ml, very close to the MIC80 obtained at the inoculum size of 108 cfu/ml. The antibacterial activity of R-3746 determined at 106 cfu/ml was in agreement with that determined at 108 c