[Clinical studies of PC-904 in pediatrics (author's transl)]

PC-904 was administered to 24 patients: urinary tract infections (7 cases), bronchitis (2 cases), pneumonia (3 cases), brain abscess (1 case), septicemia and the suspected cases (10 cases), and buttock abscess (1 case). The daily dosage varied from 60 to 223.4 mg/kg and averaged 86.9 mg/kg. The drug was administered three times a day by 1-hour drip infusion, and the duration of the treatment averaged 11 days. Clinical results were obtained as excellent responses in 5 cases, good in 13, poor in 4, and unknown in 2, giving 75% of the clinical effectiveness. Bacteriological responses were excellent in 7, good in 2, poor in 2, and unknown in 13, and the overall effectiveness was evaluated as excellent in 2, good in 17, and unknown in 5. Antibacterial activities against clinically isolated bacteria were examined. MIC values of PC-904 were over 100 mg/ml 1 strain of E. coli and 2 strains of Klebsiella, however excellent sensitivities were observed in 3 strains of Ps. aeruginosa and MIC values varied 1.56 to 3.12 microgram/ml at 10(8) of inoculum size and 0.78 to 1.56 microgram/ml at 10(8). As to side effects, diarrhea was observed in 1 case, rash in 2, lowering ob blood pressure in 2, elevation of GOT in 1, and elevation of LDH in 2. Abnormal elevations of GOT (10 cases), GPT (5 cases), A1-P (1 case), LDH (7 cases), and BUN (1 case) were noticed in other patients, but it was considered to be due to underlying diseases.