Imipenem/cilastatin for pediatric infections in hospitalized patients.
One hundred and four children who were hospitalized for documented or suspected non-CNS bacterial infections (56 males/48 females, 22 days to 15 years old) were treated with intravenous imipenem/cilastatin for 9.4 days (range 3 to 28 days). Children up to three years of age received 100 mg/kg/day and older children 60 mg/kg/day, administered in four divided doses. Bacterial pathogens were isolated before therapy in 85%. Diagnoses in the 74 evaluable patients included bronchopneumonia with or without empyema (20%), peritonitis complicating appendicitis (16%), skin/soft tissue abscesses (14%), septicemia (11%) and miscellaneous other infections (39%). Among evaluable patients, 95% were clinically cured or improved. One patients, a marasmic child with pneumonitis due to pseudomonas, died during therapy. One evaluable patient each with shigellosis, Klebsiella pneumoniae empyema and streptococcal pneumonia had bacteriologic eradication or suppression but, due partly to noninfectious complications, had no overall clinical improvement. Most bacterial isolates (101/108) were eradicated, including many gram-negative and gram-positive aerobes and anaerobes; three pathogens persisted (one Proteus mirabilis and one Salmonella typhi, one Staphylococcus aureus); and one Escherichia coli pyelonephritis recurred after therapy ended too early. Imipenem/cilastatin was well tolerated by 91% of children. Clinical adverse experiences (AEs), none serious except for the one death, occurred in 19%; 12% were judged possibly related to imipenem/cilastatin, but none probably or definitely related. No serious laboratory AEs occurred; the most common AEs were eosinophilia (11%), urine discoloration, and infusion site pain. Imipenem/cilastatin is well tolerated and has excellent clinical efficacy in a wide variety of pediatric infections.
Nalin
D R
DR
Merck Sharp & Dohme Research Laboratories, Rahway, New Jersey 07065.
Hart
C B
CB
Shih
W J
WJ
Aziz
M A
MA
D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D015377:Cilastatin; D000077728:Cilastatin, Imipenem Drug Combination; D002986:Clinical Trials as Topic; D003521:Cyclopropanes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004338:Drug Combinations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D015378:Imipenem; D007223:Infant; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D008297:Male; D013845:Thienamycins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
D000900:Anti-Bacterial Agents; D003521:Cyclopropanes; D004338:Drug Combinations; D013845:Thienamycins; D015377:Cilastatin; D015378:Imipenem; D000077728:Cilastatin, Imipenem Drug Combination