Clinical and pharmacokinetic study of a single daily dose of amikacin in paediatric patients with severe gram-negative infections.
The efficacy and safety of a single 20 mg/kg daily dose of amikacin was studied in an open, uncontrolled trial in 56 infants and children. Most of the patients suffered from severe Gram-negative infection which had failed to respond to previous antibacterial therapy. Amikacin was given in combination with a beta-lactam antibiotic in 43 cases, with other antibiotics in five cases and monotherapy in eight cases. Pseudomonas aeruginosa was the most frequently isolated organism (27 cases). Clinical results were satisfactory in 98% of the infections treated. Two patients died, one from the infection and the other 8 weeks after therapy from unrelated causes. Amikacin serum concentrations were high during the first hour after iv infusion, low after 8 h and undetectable at 24 h. Nephrotoxicity and ototoxicity was not detected in any patient. Amikacin when used as a single daily dose in combination with a beta-lactam antibiotic was effective and safe in treating infants and children with severe Gram-negative infection.
Kafetzis
D A
DA
Second Department of Pediatrics, University of Athens, Greece.
Sianidou
L
L
Vlachos
E
E
Davros
J
J
Baïramis
T
T
Papandreou
Y
Y
Paraskaki
E
E
Scouroliakou
M
M
Hadzis
A
A
Papadatos
J
J
D000293:Adolescent; D000583:Amikacin / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D001424:Bacterial Infections / Q000188:drug therapy* / Q000378:metabolism; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000493:pharmacokinetics; D005260:Female; D006090:Gram-Negative Bacteria; D006309:Hearing / Q000187:drug effects; D006801:Humans; D007223:Infant; D007668:Kidney / Q000187:drug effects; D007769:Lactams; D008297:Male; D011550:Pseudomonas aeruginosa
D000900:Anti-Bacterial Agents; D007769:Lactams; D000583:Amikacin