isepamicin and Escherichia-coli-Infections

In this study we compared the efficacy and safety of isepamicin versus amikacin at a dose of 7.5 mg/kg i.v. q12h for 10-14 days in children with pyelonephritis. Sixteen children were enrolled in the study; ten received isepamicin and six amikacin. Urine cultures grew Escherichia coli in all patients. All patients were treated successfully with either isepamicin or amikacin. Clinical and bacteriological response rates were 100% for both groups. No adverse events occurred. Peak serum levels ranged from 9.05 to 30.70 mg/l (median: 16.165) and from 12.20 to 25.90 mg/l (median: 19.05) for isepamicin and amikacin, respectively. Trough serum levels ranged from 0.11 to 3.20 mg/l (median: 0.75) and from 0.1 to 2.1 mg/l (median: 0.655), respectively. Isepamicin was shown to be as effective and safe as amikacin in the treatment of children with pyelonephritis and might prove an advantageous alternative in areas with high incidence of resistance to other aminoglycosides.

Topics: Amikacin; Anti-Bacterial Agents; Child; Child, Preschool; Escherichia coli; Escherichia coli Infections; Female; Gentamicins; Humans; Infant; Infant, Newborn; Male; Pyelonephritis; Treatment Outcome; Urine

In a series of three prospective, randomised, multicentre trials, isepamicin (15 mg/kg or 8 mg/kg once daily depending on severity of infection) was compared with amikacin (7.5 mg/kg twice daily) in a total 252 adult hospitalised patients (mean age 51-54 years) with urinary tract infection. Pretreatment pathogens included Escherichia coli, which was isolated from approximately 50% of patients, and Pseudomonas aeruginosa, which was isolated from approximately 10% of patients with severe infections. The most commonly occurring primary diagnoses were complicated pyelonephritis, uncomplicated pyelonephritis and complicated lower urinary tract infection. For the patients included in the efficacy population, elimination of the pathogens occurred for all infections combined, in 92/101 (91%) patients in the isepamicin group and 51/55 (93%) patients in the amikacin group. Adverse events occurred in 15% of isepamicin patients and 6% of amikacin patients. Ototoxicity at the > or = dB threshold was noted in one isepamicin and two amikacin patients, but none of these patients had associated clinical signs of auditory or vestibular toxicity. Four isepamicin and four amikacin patients had potentially significant increases in serum creatinine indicative of possible nephrotoxicity.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amikacin; Anti-Bacterial Agents; Escherichia coli Infections; Female; Follow-Up Studies; Gentamicins; Humans; Male; Middle Aged; Prospective Studies; Pseudomonas aeruginosa; Pseudomonas Infections; Urinary Tract Infections

Two hundred and three patients with skin and skin structure infections were treated with isepamicin once daily or amikacin twice daily in an open, randomised, comparative multicentre trial. Patients were randomised to treatment with isepamicin or amikacin in a 2:1 ratio. Severe infections (63 patients) were treated with isepamicin 15 mg/kg once daily (n = 15) or amikacin 7.5 mg/kg twice daily (n - 18), less severe infections (140 patients) with isepamicin 8 mg/kg once daily (n = 93) or amikacin 7.5 mg/kg twice daily (n = 47). The overall clinical response rate at the end of treatment was excellent in all treatment groups (94-96% cured or improved) with no significant differences between isepamicin and amikacin in patients with either server or less severe infections. The most commonly isolated target pathogens were Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis and Staphylococcus aureus. Overall, in patients who had a valid target pathogen isolated prior to treatment and who met other evaluability criteria, bacteriological eradication was achieved in over 90% of patients; amikacin patients with severe infections had a somewhat lower eradication rate (82%). Over all infections, 4/110 (4%) patients in the isepamicin group and 5/54 (9%) patients in the amikacin had organisms which persisted. Adverse events were reported in 12% of patients in the isepamicin group and 6% in the amikacin group. The most frequently reported adverse event in the isepamicin group as headache. Two patients (one in each treatment group), both of whom experienced skin rashes, were withdrawn. Potentially clinically significant changes in serum creatinine occurred in two patients, who received isepamicin and one who received amikacin (who was withdrawn from the study). Ototoxicity was rare, occurring in one patient treated with isepamicin.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amikacin; Anti-Bacterial Agents; Drug Administration Schedule; Escherichia coli Infections; Female; Gentamicins; Gram-Negative Bacterial Infections; Humans; Male; Middle Aged; Proteus Infections; Proteus mirabilis; Pseudomonas aeruginosa; Pseudomonas Infections; Skin Diseases, Bacterial; Staphylococcal Skin Infections; Staphylococcus aureus

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.

Topics: Adolescent; Amikacin; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Drug Administration Schedule; Enterococcus faecalis; Escherichia coli Infections; Female; Gentamicins; Humans; Infant; Infant, Newborn; Klebsiella Infections; Klebsiella pneumoniae; Male; Staphylococcal Infections; Staphylococcus epidermidis; Streptococcal Infections