A clinical study on imipenem/cilastatin sodium in the field of pediatrics

A clinical study on imipenem/cilastatin sodium (MK-0787/MK-0791) was carried out and the following results were obtained. MK-0787/MK-0791 was used for treatment of a total of 33 patients and clinical effectiveness, bacteriological efficacy and adverse reactions were evaluated. The clinical effects were excellent in 1 case, good in 21 cases and fair in 2 cases in a total of 24 cases with respiratory tract infections, were excellent in 5 cases and good in 1 case in a total of 6 cases with urinary tract infections, and were good in 2 cases and fair in 1 case in a total of 3 cases with gastroenteritis. Causative organisms isolated from 11 patients were 1 strain of Gram-positive cocci and 10 strains of Gram-negative bacilli. Ten out of 11 strains were eradicated for an eradication rate of 91%. The clinical efficacy was confirmed in 11 cases for an efficacy rate of 100%. The bacteriological study has shown that MK-0787/MK-0791 has a strong antimicrobial activity. No side effects were observed. There was only one abnormal laboratory finding, i.e., a case of eosinophilia.     

Studies on imipenem/cilastatin sodium in the field of pediatrics

Pharmacokinetic and clinical studies on imipenem (MK-0787)/cilastatin sodium (MK-0791), a combined drug of carbapenem antibiotics (MK-0787) and renal depeptidase inhibitor (MK-0791) in a 1:1 ratio, were performed in the field of pediatrics. Absorption and excretion Serum levels and urinary excretion of MK-0787/MK-0791 were determined in 7 children aged 4 to 11 years. Four cases were administered with a single dose of MK-0787/MK-0791 at 10 mg/10 mg/kg by intravenous drip infusion and the other 3 cases were given a single dose of 20 mg/20 mg/kg. Serum concentrations of MK-0787 reached their peaks at the end of drip infusion where the mean level was 17.5 +/- 1.0 micrograms/ml for the group given 10 mg/10 mg/kg, and 43.6 +/- 2.1 micrograms/ml for the group given 20 mg/20 mg/kg. Concentrations decreased with half-lives of 0.82 +/- 0.10 hour and 0.74 +/- 0.04 hour for the low and high doses, respectively, and serum levels at 6 hours after administration were 0.3 +/- 0.1 microgram/ml and 0.4 +/- 0.1 microgram/ml, respectively. Peak concentrations of MK-0791 were 22.6 +/- 4.8 micrograms/ml in the 10 mg/10 mg/kg group and 52.9 +/- 4.7 micrograms/ml in the 20 mg/20 mg/kg group at the end of the drip infusion. Half-lives were 0.56 +/- 0.17 hour and 0.46 +/- 0.11 hour for the 2 doses, respectively while MK-0791 levels were below detection limit at 6 hours after administration. Mean urinary recovery rates in 6 hours after administration were 54.0 +/- 15.3% and 49.3 +/- 7.8% for MK-0787 and MK-0791, respectively, in the group of 10 mg/10 mg/kg, and 62.0 +/- 7.4% and 65.3 +/- 9.2%, respectively, in the group of 20 mg/20 mg/kg. These results showed that pharmacokinetics of MK-0787 and MK-0791 in children were similar to that in adults. Clinical study MK-0787/MK-0791 was used for treatment in a total of 22 pediatric patients to evaluate clinical effectiveness, bacteriological efficacy and adverse reactions. Each of patients was treated 3 or 4 times per day at a single dose of 11.4-22.8 mg/kg (of MK-0787). Duration of treatment ranged from 2.5 to 18 days and total doses ranged from 1.36 to 19.92 g. Clinical efficacy in cases including 2 with acute purulent tonsillitis, 1 with acute purulent otitis media, 9 with acute pneumonia, 1 with pythorax, 3 with acute purulent lymphadenitis, and 6 with acute pyelonephritis were judged excellent in 20 cases and good in 2 cases; an efficacy rate of 100%.(ABSTRACT TRUNCATED AT 400 WORDS)     

Fundamental and clinical studies on imipenem/cilastatin sodium in the field of pediatrics

Fundamental and clinical studies on imipenem/cilastatin sodium (MK-0787/MK-0791) were performed in pediatric patients with infections. Results obtained were summarized below. The mean plasma half-life of MK-0787 was 0.84 hour with a dosage of 10 mg/kg and 0.90 hour with a dosage of 20 mg/kg. Mean plasma half-lives of MK-0791 were 0.40 hour and 0.71 hour for dosages of 10 mg/kg and 20 mg/kg, respectively. Urinary recovery of both MK-0787 and MK-0791 was high. The antibacterial activity of MK-0787 against clinically isolated organisms was determined. The MK-0787 was bactericidal against a broad spectrum of both Gram-positive and Gram-negative pathogens. The MK-0787/MK-0791 was administered to 32 pediatric patients with various infections. The overall clinical efficacy rate was 96.9%. Side effects observed were loose stools in one patient, diarrhea in another and slight elevations of platelet and direct bilirubin, and eosinophilia were observed in 3 patients, respectively.     

Clinical studies on imipenem/cilastatin sodium in pediatric field

Clinical studies on imipenem/cilastatin sodium (MK-0787/MK-0791) was carried out in 12 patients in pediatric field. The overall efficacy rate was 83.3%. As for adverse reaction, soft stool was observed in 1 patient. In clinical laboratory findings, there was 1 patient with granulocytopenia.     

Fundamental and clinical evaluation of imipenem/cilastatin sodium in the field of pediatrics

A combination drug of imipenem (MK-0787), a new carbapenem antibiotic, and cilastatin sodium (MK-0791) at a ratio of 1:1 was used to treat infections in 8 children, and the concentrations of MK-0787 were determined in plasma, urine and pus of 1 patient and in cerebrospinal fluid of another patient. Eight patients, aged 2 months to 12 years (males: 3, females: 5), were treated with MK-0787/MK-0791. They consisted of 3 with urinary tract infections (causative organisms: E. coli, K. oxytoca plus E. faecalis, and unknown), and 1 patient each with pneumonia (H. influenzae), enteritis (Salmonella C1), cellulitis (S. aureus), purulent lymphadenitis (unknown) and purulent meningitis (E. coli). The dose, ranging from 7.4 mg/7.4 mg/kg to 11.8 mg/11.8 mg/kg, 3 or 4 times daily, was administered by a 30-minute or 60-minute intravenous drip infusion for 5 to 11 days. To the patient with purulent meningitis, however, 25.85 mg/25.85 mg/kg on the 1st day and 12.9 mg/12.9 mg/kg from the 2nd day were administered 4 times daily. Clinical responses in urinary tract infections were excellent in 2 and good in 1, and responses in pneumonia, enteritis, cellulitis, purulent lymphadenitis and purulent meningitis were excellent, good, good, excellent and poor, respectively. The efficacy rate in a total of 8 patients was 87.5%. As adverse reactions, a rash was observed in one patient and a convulsion in another. The rash disappeared after discontinuation of the administration of the drug and the convulsion stopped after a reduction of the dosage. As abnormal laboratory findings, slight prolongation of the prothrombin time was observed in 1 patient, but no bleeding tendency was noted. When MK-0787/MK-0791 (500 mg/500 mg, or 8.7 mg/8.7 mg/kg) was given by a 60-minute intravenous drip infusion to a 12-year-old boy with cellulitis, the peak plasma concentration of MK-0787 was 31.4 micrograms/ml occurring at the end of the infusion, and then the concentration decreased to 13.9 micrograms/ml in 0.5 hour, 8.9 micrograms/ml in 1 hour, 2.8 micrograms/ml in 2 hours, 0.63 microgram/ml in 4 hours and 0.14 microgram/ml in 6 hours. The half-life was 0.83 hour. These plasma levels provided concentrations exceeding MIC90's against major infective bacteria for 2 hours. The urinary recovery in the first 7 hours was 75.0%, and the urinary concentration was greater than 100 micrograms/ml for 5 to 7 hours.(ABSTRACT TRUNCATED AT 400 WORDS)     

Clinical evaluation of imipenem/cilastatin sodium in the pediatric field

Imipenem/cilastatin sodium (MK-0787/MK-0791) was evaluated for its safety and efficacy in 7 pediatric patients with infections. The clinical efficacy ratio was 100 percent. No side effect was observed except for elevations of S-GOT and S-GPT and eosinophilia in 1 patient. It may be considered that MK-0787/MK-0791 is a safe and useful antibiotic for the treatment of pediatric infections.     

Fundamental and clinical studies on imipenem/cilastatin sodium in pediatrics

Fundamental and clinical studies were carried out on imipenem/cilastatin sodium (MK-0787/MK-0791) in pediatric patients. The following results were obtained. A total of 238 clinical isolates stocked by our department was employed to determine the minimum inhibitory concentrations (MICs) of MK-0787 against various species of bacteria. The MK-0787 showed strong antibacterial activities against E. coli, Salmonella, Klebsiella, Proteus, Serratia, E. faecalis and S. epidermidis. Somewhat weaker activities were observed against P. aeruginosa and S. aureus. The MK-0787/MK-0791 was drip-infused intravenously into patients over a period of 1 hour, and serum levels of MK-0787 and MK-0791 were determined. At the dose level of 10 mg/10 mg/kg, the mean serum levels of MK-0787 and MK-0791 were 29.9 micrograms/ml and 18.1 micrograms/ml at 1 hour and 3.4 micrograms/ml and 1.3 micrograms/ml at 3 hours, respectively. The half-lives were 0.89 hour for MK-0787 and 0.99 hour for MK-0791. At the dose level of 20 mg/20 mg/kg, the mean serum levels of MK-0787 and MK-0791 were 46.3 micrograms/ml and 45.2 micrograms/ml at 1 hour and 5.5 micrograms/ml and 3.1 micrograms/ml at 3 hours, respectively. The half-lives were 0.97 hour for MK-0787 and 0.83 hour for MK-0791. At the dose level of 40 mg/40 mg/kg, the mean serum levels of MK-0787 and MK-0791 were 104.0 micrograms/ml and 80.9 micrograms/ml at 1 hour and 7.8 micrograms/ml and 5.9 micrograms/ml at 3 hours, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)     

Clinical study of imipenem/cilastatin sodium in the perinatal period

A clinical study was carried out on imipenem/cilastatin sodium (IPM/CS) in the perinatal period, and the results obtained are summarized as follows. IPM/CS was given to 5 cases with puerperal intrauterine infection and 2 with puerperal fever. The clinical efficacies were evaluated as good in 6 cases and poor in 1. The clinical efficacy rate was 85.7%. In a bacteriological examination, 9 strains were isolated from 6 cases, and 7 strains were eradicated with an eradication rate of 77.8%. No side effects were observed in any of the cases treated with IPM/CS.     

Clinical studies on imipenem/cilastatin sodium in the field of obstetrics and gynecology

The penetration of imipenem/cilastatin sodium (MK-0787/MK-0791) into tissues of 6 patients and clinical efficacy in 21 patients with infectious diseases were studied in the field of obstetrics and gynecology. The results are summarized below. The transfer of MK-0787/MK-0791 into genital organ tissues was very good. The clinical efficacy was evaluated for 11 patients with intrauterine infections, 5 patients with intrapelvic infections and 5 patients with other infections. Clinical responses were excellent in 7 (33.3%), good in 13 (61.9%) and poor in 1 patient (4.8%), and the efficacy rate was 95.2 percent. Infective bacteria were eradicated in 4, diminished in 2, unchanged in 1 and replaced by other bacteria in 2 patients. No side effect was observed.     

Clinical study of intramuscular imipenem/cilastatin sodium in the field of obstetrics and gynecology]

We evaluated the clinical efficacy and safety of intramuscular (as a new route of administration) imipenem/cilastatin sodium (IPM/CS) in patients with intrauterine infections which are typical in the field of obstetrics and gynecology. The obtained results are summarized as follows. 1. Twenty-seven patients were treated with IPM/CS, 250 mg/250 mg b.i.d. (3 patients), 500 mg/500 mg b.i.d. (22) and other dosages (a change in dosing regimen, 2). The duration of treatment ranged from 3 to 11 days and the total dosage during an entire course of treatment varied from 1.5 to 9.0 g. The drug was suspended in a lidocaine solution and administered in the gluteal muscle of the patients. 2. Clinical efficacies were excellent in 7 patients (26%), good in 19 (70%) and poor in 1 (4%) and the overall efficacy rate was 96.3%. All of the 8 patients who had not previously showed improvements with treatment by other antibiotics responded well to this drug. 3. Bacteriologically, the clinical efficacy rate was 95.8% (23/24) and the eradication rate was 76.2% (16/21). 4. No adverse effects due to the drug were observed. As abnormal laboratory test results, transient elevations of GOT and GPT were noted in one patient.     

Clinical trials of imipenem/cilastatin sodium in the field of obstetrics and gynecology

Many different infections including urinary tract infections occur in the field of obstetrics and gynecology. Furthermore, in most cases, it is practically impossible to clearly identify causative organisms as in cases of pelvic peritonitis and parametritis. In many incidents, causative organisms consist mainly of Escherichia coli, and recently, Enterococcus faecalis, Bacteroides fragilis, Klebsiella pneumoniae, Pseudomonas aeruginosa, etc. have also been identified. Because the new antibiotic, imipenem/cilastatin sodium (MK-0787/MK-0791), is very effective against these bacteria, and because of its wide spectrum, we believe it is especially effective against infections of obstetrics and gynecology. The distribution of this antibiotic into various organs and tissues was similar to other drugs, and it reaches a high level in internal genital organs, hence it should be effective for the treatment of obstetric/gynecological infections. Its toxicity is low also, and no side effects nor abnormal laboratory findings were observed in our trials. Results of our trials are summarized below: Of 9 cases of obstetric/gynecological infections, the antibiotic showed excellent effectiveness against 2, good against 6, for the efficacy ratio of 89%. No side effects nor abnormal laboratory findings were observed.     

Clinical evaluation of imipenem/cilastatin sodium in children

Nine pediatric patients with moderate or severe bacterial infections (3 septicemia or bacteremia, 2 pyelitis, 2 tonsillitis, 1 pneumonia and 1 pyothorax) in hospital were treated with MK-0787/MK-0791. The drug was administered intravenously by 30 or 60 minutes drip infusion in 3 or 4 divided doses totalling 24 mg/24 mg-70.2 mg/70.2 mg per kg/day. Clinical effectiveness were excellent in 4 cases, good in 2 cases, poor in 2 cases and not evaluated in 1 case. The overall efficacy rate was 75%. A slight decrease of WBC was observed in 1 case. It was concluded that MK-0787/MK-0791 was a useful antibiotic for the treatment of infections in pediatric practices. Pharmacokinetics of intravenously administered MK-0787/MK-0791 was studied in 2 other cases. The MK-0787/MK-0791 was administered intravenously by 30 or 60 minutes drip infusion to 2 cases at a dose of 10 mg/10 mg/kg. The mean half-life (T1/2) of MK-0787 was 1.03 hours and MK-0791, 0.69 hour. The mean urinary recovery rate of MK-0787 within 6.5-7 hours after administration was 62.5% and MK-0791, 76.7%.     

Clinical studies on imipenem/cilastatin sodium in the field of obstetrics and gynecology]

The efficacy and safety of imipenem/cilastatin sodium (IPM/CS) were studied in patients with obstetric and gynecologic infections and in those given the drug as prophylaxis against postoperative infections. The following results were obtained: 1. Efficacy rates were 96.0% (48/50) in patients with obstetric and gynecologic infections and 100% (28/28) in those with urinary tract or other infections. The overall efficacy rate was 97.4% (76/78). Bacteriologically, 30 organisms were isolated from 28 patients. The eradication rate was 95.2% (20/21) and the efficacy rate was 96.4% (27/28). 2. Changes in blood elastase before and after treatment were compared with those in CRP, WBC, and ESR in the patients with obstetric and gynecologic infections. The changes in elastase were similar to those in CRP. 3. The efficacy rate was 98.0% (48/49) in the patients given prophylaxis against postoperative obstetric and gynecologic infections. 4. An adverse reaction was observed in only one patient (diarrhea), and abnormal laboratory findings were noted in 2 patients (elevation of GOT and GPT). These results indicate that IPM/CS is very useful for the treatment of obstetric and gynecologic infections.     

Clinical studies on imipenem/cilastatin sodium in the perinatal period

Clinical studies were carried out on imipenem/cilastatin sodium (IPM/CS) in the perinatal period, and the results are summarized below. 1. IPM/CS was administered to a total of 10 patients including 7 with puerperal intrauterine infections and 3 with pyelonephritis at a dose of 0.5 g/0.5 g twice daily through intravenous drip infusion. IPM/CS showed satisfactory results. Clinical efficacies were excellent in 1 patient, good in 9 with an efficacy rate of 100%. 2. As for bacteriological evaluation, 12 strains out of 14 detected in 8 patients before the treatment were eradicated upon IPM/CS administration, with an eradication rate of 85.7%. The remaining 2 strains persisted. 3. Neither subjective and objective side effects nor abnormal laboratory test values were observed in any of the patients or their babies.     

Clinical studies on imipenem/cilastatin sodium in perinatal use

The clinical efficacy and the safety of imipenem/cilastatin sodium (IPM/CS) in perinatal infections were studied. The results are summarized below. 1. Clinical efficacy was evaluated in 12 patients with intrauterine infections (endometritis), 3 patients with amniotic fluid infections, 2 patients with puerperal fever and 3 patients with other infections. The drug was administered by intravenous drip infusion at a 0.5g to 1.0g dose as IPM and the total doses during an entire course of treatment were 1.5g to 15g. 2. Clinical efficacies were excellent in 4 (20%) and good in 16 patients (80%) and the efficacy rate was 100%. Ten patients had not improved upon treatments with other previous antibiotics. 3. Infective bacteria were eradicated in 4, decreased in 1, and replaced in 6 patients. 4. No side effects or abnormal clinical laboratory test values were observed in any patient.     

Clinical study of imipenem/cilastatin sodium in children with severe infections

Clinical studies of imipenem/cilastatin sodium (IPM/CS) were conducted in 40 pediatric patients. 29 out of the 40 patients were treated for infections and 11 for prophylaxis. The following results were obtained. 1. The response rate in 29 patients with infections was 79.3%. Among the 29 patients, 16 patients who presented with malignant diseases showed the response rate of 68.8%. The response rate was lower in patients with severe infections than in those with mild or moderate infections, and a lower response rate was associated with severe neutropenia. However, there were no differences in the response rates between patients who had previously been treated and those who had been untreated with other antibiotics. The response rate in 6 patients from whom causative organisms were isolated was 83.3% and that in the remaining 23 patients was 78.3%. 2. The response rate in 11 patients to whom IPM/CS was administered prophylactically was 63.6%. 3. As for side effects, a rash was observed in 1 patient and hematuria in another, and the abnormal laboratory test results observed were elevations of GOT and GPT in 1 patient. However, they were not clinically significant. From the above results, it appears that IPM/CS may be used as a drug of the first choice for the treatment of patients with severe infections in which the causative organisms are unknown, and for the prophylaxis of infection in patients with neutropenia.     

Clinical evaluation of imipenem/cilastatin sodium in gynecological infection

The MK-0787/MK-0791 is a combination of imipenem (a carbapenem antibiotic) and cilastatin sodium (a dehydro peptidase-I inhibitor) in a 1 to 1 ratio, which produces a higher urinary recovery of imipenem than imipenem alone. The MK-0787/MK-0791 was used in 8 female patients with intrapelvic infections. Clinical efficacies were very good in all the patients. There were neither subjective nor objective side effects nor abnormal laboratory findings.     

Clinical evaluation of imipenem/cilastatin sodium in the internal medicine

Fifty-two patients with moderate or severe infections associated with internal medicine were treated with imipenem/cilastatin sodium (IPM/CS) and the efficacy and the safety of this drug were evaluated. There were 20 patients with pneumonia, 10 with acute exacerbation of chronic respiratory tract infections, 9 with sepsis, 2 with pyothorax, 3 with intraabdominal infection, 2 with urinary tract infection, 1 with pulmonary abscess, 1 with infective endocarditis, 4 with fever of unknown origin. Forty-four patients were evaluable for the efficacy. Clinical efficacies were excellent in 12 patients, good in 26, fair in 3 and poor in 3. The overall clinical efficacy was 86.4%. The efficacy rate was 63.6% in patients previously treated and 93.9% in patients previously untreated with other antibiotics. Bacteriologically, Staphylococcus aureus (8 strains), Streptococcus pneumoniae (5), Streptococcus pyogenes (1), other Gram-positive coccus (1), Klebsiella pneumoniae (8), Haemophilus influenzae (4), Pseudomonas aeruginosa (3), Serratia marcescens (3), Escherichia coli (3), Branhamella catarrhalis (1), Citrobacter freundii (1), Klebsiella oxytoca (1), Enterobacter sp. (1), and Peptostreptococcus sp. (1) were eradicated. P. aeruginosa (3) and Acinetobacter sp. (1) decreased. S. aureus (1), S. epidermidis (1), P. aeruginosa (5), and S. marcescens (1) persisted or appeared. The eradication rate was 83.7%. Six patients showed adverse reactions including general fatigue 1, epigastralgia 1, eruption 1, eosinophilia 1 and elevation of S-GOT 2. But all of the adverse reactions were mild or slight, and transient. These findings indicate that IPM/CS is a useful and safe drug against bacterial infections in internal medicine.     

Fundamental and clinical studies on imipenem/cilastatin sodium in the pediatric field

Fundamental and clinical studies were performed on a newly developed carbapenem antibiotic, imipenem/cilastatin sodium (MK-0787/MK-0791), and results were summarized as follows. The antibacterial activity of MK-0787 at an inoculum of 10(6) cells/ml against strains of S. aureus which were sensitive or resistant to cefazolin (CEZ), E. coli, P. mirabilis, K. pneumoniae, S. marcescens and P. aeruginosa were determined and compared with activities of ceftazidime (CAZ), CEZ, cefmetazole (CMZ), ceftizoxime (CZX), latamoxef (LMOX), cefamandole (CMD), cefoperazone (CPZ), cefsulodin (CFS) and piperacillin (PIPC). The peak MIC of MK-0787 was less than or equal to 0.024 micrograms/ml against S. aureus, which were sensitive or resistant to CEZ, 0.10 micrograms/ml against E. coli, P. mirabilis, or K. pneumoniae, 0.39 micrograms/ml against S. marcescens and 1.56 micrograms/ml against P. aeruginosa. The antibacterial activity of MK-0787 against these bacteria was, on the whole, superior to that of CAZ, CEZ, CMZ, CZX, LMOX, CMD, CPZ, CFS or PIPC. The pharmacokinetics of MK-0787/MK-0791 was studied in 10 children at dose levels of 10 mg/10 mg/kg and 20 mg/20 mg/kg by a 30-minute intravenous drip infusion. Maximum serum levels of MK-0787, at dose levels of 10 mg/10 mg/kg and 20 mg/20 mg/kg were 41.6 micrograms/ml and 72.9 micrograms/ml, respectively, at the end of infusion and 0.1 micrograms/ml at 6 hours, respectively, after drip infusion. The half-life of both dose levels was 0.9 hour. Mean peak serum levels of MK-0791, at dose levels of 10 mg/10 mg/kg and 20 mg/20 mg/kg, were 49.7 micrograms/ml and 87.0 micrograms/ml, respectively, with half-life of 1.1 and 0.6 hour, respectively. Urinary recovery rates of MK-0787 for 6 hours at dose levels of 10 mg/10 mg/kg and 20 mg/20 mg/kg, were 47.8-82.7% and 25.5-78.0%, respectively, and of MK-0791 for 6 hours were 51.7-93.4% and 40.3-94.4%, respectively. Twenty-four patients, including 1 with purulent meningitis, 1 with septicemia, 1 with pyothorax, 10 with bronchopneumonia, 7 with pyelonephritis and 4 with infections of cutaneous soft tissue were treated with MK-0787/MK-0791 at dose levels of over 100 mg/100 mg/kg/day with purulent meningitis and septicemia and 28.8 mg/28.8 mg-72.8 mg/72.8 mg/kg/day with other infections. The clinical response in all patients was excellent or good.(ABSTRACT TRUNCATED AT 400 WORDS)     

Basic and clinical studies on imipenem/cilastatin sodium in the pediatric field

Basic and clinical studies have been performed on imipenem/cilastatin sodium (MK-0787/MK-0791) in the pediatric field. Antibacterial activities of MK-0787 against 14 clinical isolates of S. aureus and 67 isolates of E. coli were determined. The MIC of MK-0787 was 0.10 microgram/ml or less against all 14 strains of S. aureus. The MIC of MK-0787 was 0.39 microgram/ml or less against all 67 strains of E. coli. The pharmacokinetics of MK-0787/MK-0791 was studied at dose levels of 10 mg/10 mg/kg and 20 mg/20 mg/kg. The peak serum levels of MK-0787 achieved approximately 1 hour after the administration of 10 mg/10 mg/kg and 20 mg/20 mg/kg doses were 38.6 micrograms/ml and 36.2 micrograms/ml, respectively. The serum half-lives were 0.8 hour and 0.9 hour, respectively. The total 6-hour urinary excretions were 82.1% and 66.7%, respectively. The MK-0787/MK-0791 was administered to 13 children with bacterial infections. The clinical results were excellent or good in all cases. The overall efficacy rate was 100%. As a side effect, diarrhea was observed in 1 patient. Abnormalities in laboratory findings observed were elevation of direct bilirubin in 1 patient, thrombocytosis in 2, and a prolonged prothrombin time in 1 patient. Based on the above results, it can be concluded that MK-0787/MK-0791 is a safe and effective drug to use for the treatment of pediatric infections.