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Imipenem/cilastatin for pediatric infections in hospitalized patients
Insights
Intravenous imipenem/cilastatin effectively treated bacterial infections in children, showing high cure rates and good tolerability. This broad-spectrum antibiotic is a valuable option for pediatric bacterial infections.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Pharmacology
- Bacteriology
Background:
- Bacterial infections pose significant health risks to hospitalized children.
- Effective and well-tolerated antimicrobial agents are crucial for pediatric care.
- Imipenem/cilastatin is a broad-spectrum antibiotic with potential utility in pediatric infections.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of intravenous imipenem/cilastatin in pediatric patients with documented or suspected bacterial infections.
- To assess the tolerability and adverse event profile of imipenem/cilastatin in children.
- To determine the impact of imipenem/cilastatin on bacterial eradication in pediatric infections.
Main Methods:
- A prospective study involving 104 hospitalized children (22 days to 15 years) treated with intravenous imipenem/cilastatin.
- Dosage adjusted based on age: 100 mg/kg/day for children up to 3 years, 60 mg/kg/day for older children, divided into four doses.
- Clinical and microbiological outcomes were assessed in 74 evaluable patients.
Main Results:
- 95% of evaluable patients achieved clinical cure or improvement.
- Bacterial pathogens were isolated in 85% of patients prior to therapy.
- Most bacterial isolates (101/108), including gram-negative, gram-positive, aerobes, and anaerobes, were eradicated.
Conclusions:
- Intravenous imipenem/cilastatin demonstrated excellent clinical efficacy and was well tolerated in a wide range of pediatric bacterial infections.
- The antibiotic achieved high rates of clinical improvement and bacterial eradication.
- Adverse events were generally mild, with imipenem/cilastatin being a safe and effective treatment option for pediatric patients.
Abstract:
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.