CLINICAL TRIALS OF CEFROXADINE ON SKIN AND SOFT TISSUE INFECTIONS IN THE FIELD OF PEDIATRICS

Abstract

CXD was administered orally at an average dose of 28.6mg/kg (18.3-42.3mg/kg) for an average 6 days (3-12days) to a total of99pediatric cases with skin and soft tissue infections (impetigo 89, abscess7 and furuncle 3) ranging from 3 months to 9 years old. The drug was given twice to4times per day after meals.The clinical and bacteriological effects and adverse reactions of CXD as well asthe susceptibility of the causative organisms against CXD and CEX were studied, and the results obtained are as described below:
1. According to judgement of the attending doctors, CXD had a high global efficacy rate of90.9%.
2. Analysis of the attending physicians' evaluations of the clinical effects on impetigo revealed that a dose of CXD 20.5-30.4mg/kg t.i.d. can produce satisfactory responses.
3. According to the assessments by Evaluation Committee, the global clinical effects after 3, 5 and 7 days were 81.4, 91.2 and 94.6%, respectively. This indicates that clinical responses increased with prolongation of the treatment period, viz. better responses obtained after 5 and 7 days. This suggests that a minimum of 5 days administration is required for treating these infections.
4. As for impetigo having the largest number of patients in this study, a dose of CXD 20.5-30.4 mg/kg per day seemed to produce satisfactory clinical effects.
5. As for dose per day, the t.i.d.regimen of CXD 20.5-30.4mg/kg seemed to exhibit satisfactory clinical responses, as already mentioned. Because of quite a small number of patients on the q i.d. egimen of higher doses, however, the question of whether the t.i.d. treatment with 20.5-30.4mg is adequate or not should be determined by a comparative study between the q.i.d. and t.i.d. treatments.
6. As for bacteriological responses, a high global effect of 87.1% was obtained with CXD against S. aureus and S. pyogenes isolated from 74 and 1cases, respectively.
7. As for impetigo with predominant number of cases, CXD was highly effective bacteriologically at a daily dose of 20.5-30.4mg/kg t.i.d. As an appropriate comparative evidence with the q.i.d. treatment was lacking, however, therapeutic validity of the t.i.d. treatment could not be determined definitely.
8. Utility was evaluted by the attending physicians on the total 99 cases, and CXD showed as high as 88.9%.
9. There were neither non-compliances nor adverse reactions to this treatment.
10. CXD showed a distribution of antimicrobial activity similar to that of CEX, against 74 isolates of S. aureus with the MICs of CXD ranging from 1.56 to 25mcg/ml and those of CEX ranging from.78 to 25mcg/ml, with peak MIC being 3.13mcg/ml for both drugs. As for S. pyogenes, only one isolate from the same species, CXD was antimicrobial activity at 0.2mcg/ml and CEX was antimicrobial at 0.39mcg/ml.
The above findings suggest that CXD is highly effective against acute skin and soft tissue infections in pediatrics.