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Clinical Drug Investigation

, Volume 12, Supplement 1, pp 37–46 | Cite as

Gli Aminoglicosidi nel Trattamento delle Infezioni Pediatriche: Valutazione del Ruolo di Isepamicina

  • Alessandra Viganò
  • Nicola Principi
Article
  • 3 Downloads

Summary

A large proportion of aerobic Gram-negative organisms, which are responsible for a variety of serious infections especially in hospitalised patients, are susceptible to aminoglycosides. In paediatrics, the clinical situations in which these agents are useful include sepsis and pneumonia in neonates, sepsis in neutropenic patients, respiratory tract infections in patients with cystic fibrosis, endocarditis and urinary tract infections. Isepamicin is a new aminoglycoside antibiotic, which, compared with currently available agents of this class, demonstrates superior stability in the presence of aminoglycoside-inactivating enzymes.

A multicentre international study compared the efficacy and safety of isepamicin 7.5 mg/kg twice daily and amikacin at the same dosage regimen in the treatment of various infections in neutropenic and non-neutropenic paediatric patients. A total of 306 patients were enrolled and received treatment (204 isepamicin, 102 amikacin: intention-to-treat population); 181 patients satisfied all criteria for evaluation (120 isepamicin, 61 amikacin: efficacy population). The cure or improvement rates in the isepamicin and amikacin groups were 188/204 (92%) vs 94/102 (92%), respectively, in the intention-to-treat population, and 117/120 (98%) vs 58/61 (95%) in the efficacy population. The bacteriological elimination rates in the isepamicin and amikacin groups were, respectively, 75/76 (99%) vs 35/38 (92%) in the intention-to-treat population (p = 0.083) and 78/98 (79%) vs 37/48 (77%) in the efficacy population. Nephrotoxicity, defined as an increase in serum creatinine of ≥ 0.5 mg/dL or ≥ 44.8 mmol/L from baseline, occurred in 4/187 (2%) and 1/91 (1%) children treated with isepamicin and amikacin respectively. A definite ototoxicity at the ≥ 20dB threshold occurred in 3 (1 isepamicin and 2 amikacin) of 56 children evaluated with at least 2 audiograms. Thus isepamicin appears to be as effective and well tolerated as amikacin in the treatment of various infections in paediatric patients.

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Bibliografia

  1. 1.
    Mc Cracken GH, Mize SS, Threlked N. Intraventricular gentamycin therapy in Gram negative bacillary meningitis of infancy. Lancet 1980; 1: 787–90Google Scholar
  2. 2.
    Shapiro ED. Short course antimicrobial treatment of urinary tract infections in children: a critical analysis. Pediatr Infect Dis J 1982; 1: 294–7CrossRefGoogle Scholar
  3. 3.
    Moffat M, Embree J, Grimm P, et al. Short-course antibiotic therapy for urinary tract infections in children. A methodological review of the literature. Am J Dis Child 1988; 142: 57–62Google Scholar
  4. 4.
    Anon F. Thirty-first General Assembly of the West Japan Branch of the Japan Society of Chemotherapy, New Drug Symposium, HAPA-B, Kanagawa Prefectural Hall, November 29th, 1984Google Scholar
  5. 5.
    Guimarase MA, Sage R, Noone P. The comparative activity of eleven aminocyclitol antibiotics against 773 aerobic Gram-negative rods and staphylococci isolated from infected hospitalized patients. J Antimicrob Chemother 1985; 16: 555–61CrossRefGoogle Scholar
  6. 6.
    Jones RN, Barry AL, Fuchs PC, et al. l-N-(S-3-amino-2-hydroxy-propionyl) gentamicin B (SCH 21420): a collaborative in vitro susceptibility comparison with amikacin and gentamicin against 12,984 clinical bacterial isolates. Curr Micro 1978; 1: 259–64Google Scholar
  7. 7.
    Neu HC, Fu KP. 1-N HAPA gentamicin B, a new aminoglycoside active against gentamicin resistant isolates — activity compared to other aminoglycosides. J Antibiot (Tokyo) 1978; 31: 385–93CrossRefGoogle Scholar
  8. 8.
    Yamaji YA, Iyobe S, Mitsuhashi S, et al. Antibacterial activity of HAPA-B. Chemotherapy 1985; 33(S5): 1–21Google Scholar
  9. 9.
    Yokoiyama S, Toriya M, Morohoshi T et al. In vitro and in vivo antibacterial activity of HAPA-B, a new aminoglycoside antibiotic. Chemotherapy 1985; 33(S5): 29–46Google Scholar
  10. 10.
    Kamiryo Y, Katao M, Sanefuji T, et al. Clinical trial of complicated urinary tract infections of HAPA-B. Hinyokika Kiyo 1986; 32: 1379–85PubMedGoogle Scholar
  11. 11.
    Kobayashi H, Oshitani H, Yoshida M, et al. Comparison of HAPA-B and amikacin in the treatment of respiratory tract infections. J Infect Dis 1986; 60: 1184–215Google Scholar
  12. 12.
    Nakaruma T, Hashimoto I, Sawada Y, et al. Clinical studies on HAPA-B following intramuscular administration on biliary tract infection and acute peritonitis (tissue concentration and clinical efficacy). Chemotherapy 1985; 33(S5): 368–80Google Scholar
  13. 13.
    Ueda T, Sakai K, Fujimoto M, et al. Antimicrobial activity and clinical studies of HAPA-B in the field of surgery. Chemotherapy 1985; 33(S5): 411–9Google Scholar
  14. 14.
    Ota J, Okuyama Y, Taguchi T, et al. Clinical evaluation of HAPA-B in the surgical field. Chemotherapy 1985; 33(S5): 420–8Google Scholar
  15. 15.
    Hiraga Y, Kikuchi K, Yamamoto A, et al. Clinical studies of HAPA-B on respiratory tract infection. Chemotherapy 1985; 33(S5); 109–14Google Scholar
  16. 16.
    Takebe K, Kitaoka M, End K, et al. Clinical study of HAPA-B. Chemotherapy 1985; 33(S5): 127–32Google Scholar
  17. 17.
    Satoh M, Adachi M, Yamagata H, et al. Fundamental and clinical study on HAPA-B. Chemotherapy 1985; 33(S5): 165–78Google Scholar
  18. 18.
    Oyama K, Shimizu R. Clinical study of HAPA-B. Chemotherapy 1985; 33(S5); 258–9Google Scholar
  19. 19.
    Shimokata K, Sakai S, Nomura F, et al. Clinical studies on HAPA-B. Chemotherapy 1985; 33(S5): 259–63Google Scholar
  20. 20.
    Arakawa S, Fujii A, Kabawata G, et al. Fundamental and clinical evaluation of HAPA-B in the field of Urology. Chemotherapy 1985; 33(S5): 529–39Google Scholar
  21. 21.
    Kitada S, Soejima T, Kumazawa J, et al. Clinical experience of HAPA-B in complicated urinary tract infection. Chemotherapy 1985; 33(S5): 572–80Google Scholar
  22. 22.
    Kiyota H, Soejima T, Kumazawa J, et al. Clinical evaluation of HAPA-B in complicated urinary tract infections. Chemotherapy 1985; 33(S5): 477–84Google Scholar
  23. 23.
    Kumon H, Okimune M, Miyata K, et al. Fundamental and clinical studies on HAPA-B in complicated urinary tract infections. Chemotherapy 1985; 33(S5): 540–58Google Scholar
  24. 24.
    Suzuki K, Tamai H, Naide Y, et al. Clinical studies of HAPA-B, a new aminoglycoside antibiotic on complicated urinary tract infections by intramuscular administration. Chemotherapy 1985; 33(S5): 505–14Google Scholar
  25. 25.
    Tominaga T, Kitahra K, Kishi H, et al. Clinical evaluation of HAPA-B in the field of urology. Chemotherapy 1985; 33(S5): 466–76Google Scholar
  26. 26.
    Umehara T, Kumamoto Y, Hirose T, et al. Basic and clinical studies on HAPA-B treatment in complicated urinary tract infections. Chemotherapy1985; 33(S5): 450–65Google Scholar
  27. 27.
    British Society of Antimicrobial Chemotherapy (Working Party). J Antimicrob Chemother 1989; 23 (Suppl. B2): 31–3Google Scholar

Copyright information

© Adis International Limited 1996

Authors and Affiliations

  • Alessandra Viganò
    • 1
  • Nicola Principi
    • 1
  1. 1.Clinica Pediatrica IVUniversità degli Studi di Milano, Ospedale “Luigi Sacco”MilanoItalia

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