[Summary of the clinical studies with azithromycin in the pediatric fields]

The clinical studies with azithromycin fine granules and capsules were conducted during the period from March 1993 to October 1994. Cmax's in 16 patients who received 10 mg/kg fine granules, were 0.29 +/- 0.24 microgram/ml, T1/2's were 42.0 +/- 11.8 hours, and AUC 0 approximately infinity's were 10.72 +/- 5.00 micrograms.hr/ml. The clinical results for azithromycin fine granule and capsules 10 mg/kg once daily for 3 days are as follows. The efficacy rate of fine granules, combining both "Excellent" and "Good", for pneumoniae where causative pathogenes were identified, was 95.3%, and for those which had failed to respond to previous chemotherapies, was 94.6%, respectively. The efficacy rate of capsules for 3 to 5 days was 100% in 40 cases where causative pathogenes were identified. Adverse reactions were found in 2.5%(fine granules) and in 5.4%(capsules) in cases eligible for evaluation. Abnormal changes in laboratory test were as follows: decrease of WBC by 5.6%(fine granules) and 9.3%(capsules) and increase in eosinophils by 7.1%(fine granules) and 11.4% (capsules). 59.8% of the patients claimed that the azithromycin 10% fine granules product was "easy to take". The result of a questionnaire on parents' demand on the improvement of antibiotics, showed that most concern was on the drug frequency(preferably once or twice daily) and the drug administering period(preferably short: 3 days). With regard to the efficacy, safety and compliance, it can be concluded that Azithromycin is one of the useful therapeutic regimens in the treatment of pediatric infections.