A Review of Results of Clinical Trials with Amikacin

Case records of 1,098 patients treated with amikacin at 79 research centers in 10 countries in a program of worldwide clinical trials were reviewed. Of the 697 patients eligible for use in evaluation of efficacy of the drug, 81% were cured, as evidenced by clinical remission and eradication of the i...

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Bibliographic Details
Published in:The Journal of infectious diseases 1976-11, Vol.134 (Supplement-2), p.S441-S445
Main Authors: Gooding, P. G., Berman, E., Lane, A. Z., Agre, K.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Amikacin - adverse effects
Amikacin - therapeutic use
Bacterial Infections - drug therapy
Bone Diseases - drug therapy
Bones
Child
Child, Preschool
Clinical trials
Clinical Trials as Topic
Dosage
Drug Resistance, Microbial
Enterobacteriaceae Infections - drug therapy
Humans
Infant
Infant, Newborn
Infections
Kanamycin - analogs & derivatives
Klebsiella
Medical cures
Middle Aged
Pathogens
Pseudomonas
Pseudomonas Infections - drug therapy
Respiratory Tract Infections - drug therapy
Sepsis
Sepsis - drug therapy
Serratia
Skin Diseases, Infectious - drug therapy
Urinary Tract Infections - drug therapy
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Summary:Case records of 1,098 patients treated with amikacin at 79 research centers in 10 countries in a program of worldwide clinical trials were reviewed. Of the 697 patients eligible for use in evaluation of efficacy of the drug, 81% were cured, as evidenced by clinical remission and eradication of the infecting pathogen. The usual dosage was 7.5 mg/ kg administered intramuscularly at 12-hr intervals. This dosage was modified in patients with renal impairment. Amikacin was effective in 90% of 322 patients with genitourinary infections, 85% of 97 patients with septicemia, 70% of 73 patients with infections of skin, soft tissue, or bone (excluding burns), and 69% of 68 patients with infections of the lower respiratory tract. Amikacin was effective in treatment of 88% of 85 infections due to gentamicin-resistant pathogens. The drug was generally well tolerated, and no side effects were reported in 80.6% of the 1,098 patients evaluated. Amikacin shares with other aminoglycosides the risk of ototoxicity and nephrotoxicity; previous exposure to gentamicin was a major factor in the development of such adverse effects. Other adverse reactions were relatively infrequent and in most cases were characterized as mild and transient.
ISSN:0022-1899
1537-6613
DOI:10.1093/infdis/135.Supplement_2.S441