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| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:dateCreated |
1996-6-14
|
| pubmed:abstractText |
The efficacy and safety of isepamicin 7.5 mg/kg of body weight twice daily or amikacin the same dosage regimen for the treatment of various infections in neutropenic and non-neutropenic paediatric patients were compared in a prospective randomised trial. In total, 306 patients were enrolled and received at least one dose of randomised treatment (204 isepamicin, 102 amikacin: intent-to-treat population); 181 patients satisfied all criteria for evaluability (120 isepamicin, 61 amikacin: efficacy population). Clinical cure or improvement rates in the isepamicin and amikacin groups were: intent-to-treat population, 188/204 (92%) and 94/102 (92%), respectively; efficacy population, 117/120 (98%) and 58/61 (95%), respectively. The bacteriological elimination rate (efficacy population) in the isepamicin and amikacin treatment groups was 75/76 (99%) vs 35/38 (92%). Nephrotoxicity, defined as an increase in serum creatinine of 0.5 mg/dL or > or = 44.2 mumol/L from baseline, occurred in 4/187 (2%) and 1/191 (1%) children treated with isepamicin and amikacin, respectively. Definite ototoxicity at the > or = 20 dB threshold occurred in 3 (1 isepamicin and 2 amikacin) out of 56 children evaluated with at least two audiograms. Thus isepamicin was as effective and as well tolerated as amikacin in the treatment of various infections in paediatric patients.
|
| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
IM
|
| pubmed:chemical | |
| pubmed:status |
MEDLINE
|
| pubmed:month |
Jun
|
| pubmed:issn |
1120-009X
|
| pubmed:author | |
| pubmed:issnType |
Print
|
| pubmed:volume |
7 Suppl 2
|
| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
95-101
|
| pubmed:dateRevised |
2009-8-4
|
| pubmed:meshHeading |
pubmed-meshheading:8622117-Adolescent,
pubmed-meshheading:8622117-Amikacin,
pubmed-meshheading:8622117-Anti-Bacterial Agents,
pubmed-meshheading:8622117-Bacterial Infections,
pubmed-meshheading:8622117-Child,
pubmed-meshheading:8622117-Child, Preschool,
pubmed-meshheading:8622117-Drug Administration Schedule,
pubmed-meshheading:8622117-Enterococcus faecalis,
pubmed-meshheading:8622117-Escherichia coli Infections,
pubmed-meshheading:8622117-Female,
pubmed-meshheading:8622117-Gentamicins,
pubmed-meshheading:8622117-Humans,
pubmed-meshheading:8622117-Infant,
pubmed-meshheading:8622117-Infant, Newborn,
pubmed-meshheading:8622117-Klebsiella Infections,
pubmed-meshheading:8622117-Klebsiella pneumoniae,
pubmed-meshheading:8622117-Male,
pubmed-meshheading:8622117-Staphylococcal Infections,
pubmed-meshheading:8622117-Staphylococcus epidermidis,
pubmed-meshheading:8622117-Streptococcal Infections
|
| pubmed:year |
1995
|
| pubmed:articleTitle |
A randomised comparison of isepamicin and amikacin in the treatment of bacterial infections in paediatric patients.
|
| pubmed:affiliation |
Department of Paediatrics, University of Milan, L. Sacco Hospital, Italy.
|
| pubmed:publicationType |
Journal Article,
Clinical Trial,
Comparative Study,
Randomized Controlled Trial,
Multicenter Study
|