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Clinical and laboratory studies with amikacin in newborns, infants, and children
Abstract:
Thirty (86%) of 35 infants and older children with proven gram-negative sepsis had a complete clinical remission after treatment with amikacin. In 27 (82%) of 33 infectious episodes for which bacteriologic results were available before and after treatment, the organism was eradicated. The dosage of amikacin was either 7.5 mg/kg or 15 mg/kg given intramuscularly at 12-hr intervals. No adverse clinical effects or laboratory abnormalities were observed during treatment, which lasted from five to 14 days. All bacteria were sensitive to amikacin when tested by the disk diffusion method, and all but a single strain of Pseudomonas were sensitive when tested by the agar dilution method. Assays of serum and urine demonstrated adequate levels of amikacin after single intramuscular injections of 3.75 or 7.5 mg/kg; simultaneous assays of serum and cerebrospinal fluid in two cases demonstrated comparable concentrations of drug suggestive of a high degree of penetration into the cerebrospinal fluid in two cases demonstrated comparable concentrations of drug suggestive of a high degree of penetration into the cerebrospinal fluid during infection. Serial measurements of amikacin in serum from 0.5 to 12 hr after administration of single doses of 7.5 mg of drug/kg to six newborns revealed no significant differences in the concentrations achieved with intramuscular or intravenous administration of the drug.
Insights
Amikacin effectively treated gram-negative sepsis in children, achieving clinical remission in 86% and eradicating bacteria in 82%. This antibiotic showed good safety and penetration into cerebrospinal fluid.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Bacteriology
Background:
- Gram-negative sepsis poses a significant threat to infants and children.
- Effective and safe antibiotic treatments are crucial for managing sepsis.
Purpose of the Study:
- To evaluate the efficacy and safety of amikacin in treating gram-negative sepsis in pediatric patients.
- To assess amikacin's pharmacokinetic properties, including penetration into cerebrospinal fluid.
Main Methods:
- A clinical study involving 35 infants and children with proven gram-negative sepsis.
- Treatment administered intramuscularly with amikacin at dosages of 7.5 mg/kg or 15 mg/kg every 12 hours for 5-14 days.
- Bacteriologic assessments, serum, urine, and cerebrospinal fluid amikacin levels were measured.
Main Results:
- Complete clinical remission was observed in 30 (86%) patients.
- Bacterial eradication occurred in 82% of infectious episodes.
- Amikacin demonstrated good safety with no observed adverse clinical or laboratory effects.
- Adequate drug levels were achieved in serum, urine, and cerebrospinal fluid, indicating good penetration.
Conclusions:
- Amikacin is an effective and well-tolerated antibiotic for treating gram-negative sepsis in pediatric patients.
- The drug exhibits favorable pharmacokinetic properties, including penetration into the central nervous system.