7432-s and Pyelonephritis

The hypothesis was tested that oral antibiotic treatment in children with acute pyelonephritis and scintigraphy-documented lesions is equally as efficacious as sequential intravenous/oral therapy with respect to the incidence of renal scarring. A randomised multi-centre trial was conducted in 365 children aged 6 months to 16 years with bacterial growth in cultures from urine collected by catheter. The children were assigned to receive either oral ceftibuten (9 mg/kg once daily) for 14 days or intravenous ceftriaxone (50 mg/kg once daily) for 3 days followed by oral ceftibuten for 11 days. Only patients with lesions detected on acute-phase dimercaptosuccinic acid (DMSA) scintigraphy underwent follow-up scintigraphy. Efficacy was evaluated by the rate of renal scarring after 6 months on follow-up scintigraphy. Of 219 children with lesions on acute-phase scintigraphy, 152 completed the study; 80 (72 females, median age 2.2 years) were given ceftibuten and 72 (62 females, median age 1.6 years) were given ceftriaxone/ceftibuten. Patients in the intravenous/oral group had significantly higher C-reactive protein (CRP) concentrations at baseline and larger lesion(s) on acute-phase scintigraphy. Follow-up scintigraphy showed renal scarring in 21/80 children treated with ceftibuten and 33/72 with ceftriaxone/ceftibuten (p = 0.01). However, after adjustment for the confounding variables (CRP and size of acute-phase lesion), no significant difference was observed for renal scarring between the two groups (p = 0.2). Renal scarring correlated with the extent of the acute-phase lesion (r = 0.60, p < 0.0001) and the grade of vesico-ureteric reflux (r = 0.31, p = 0.03), and was more frequent in refluxing renal units (p = 0.04). The majority of patients, i.e. 44 in the oral group and 47 in the intravenous/oral group, were managed as out-patients. Side effects were not observed. From this study, we can conclude that once-daily oral ceftibuten for 14 days yielded comparable results to sequential ceftriaxone/ceftibuten treatment in children aged 6 months to 16 years with DMSA-documented acute pyelonephritis and it allowed out-patient management in the majority of these children.

Topics: Administration, Oral; Adolescent; Anti-Bacterial Agents; Ceftibuten; Ceftriaxone; Cephalosporins; Child; Child, Preschool; Drug Administration Schedule; Female; Humans; Infant; Injections, Intravenous; Male; Pyelonephritis; Radionuclide Imaging; Technetium Tc 99m Dimercaptosuccinic Acid

This double-blind, multicentre study was performed at nine centres on a total of 171 patients who presented with fever (> 38.5 degrees C) and signs of acute pyelonephritis. All were initially treated with intravenous cefuroxime. After 2-3 d, when the fever had subsided and urinary culture had revealed growth of Gram-negative bacteria ( > 10(7) colony-forming units per litre), treatment was changed to oral administration of ceftibuten 200 mg b.i.d. or norfloxacin 400 mg b.i.d. for 10 d. The patients were followed for signs of bacterial or clinical relapse 7-14 d after the end of treatment. The initial clinical and bacteriological cure was excellent in both groups, but there were significantly fewer bacterial relapses after oral treatment with norfloxacin than with ceftibuten in acute febrile pyelonephritis initially treated with intravenous cefuroxime. The causal strain was eradicated in 75% of patients (73% of males, 76% of females) in the ceftibuten group and in 89% of patients (94% of males, 85% of females) in the norfloxacin group. The relative frequency of eradication was 0.84 (p < 0.05; 95%, confidence interval 0.74-0.97). Adverse events were reported by 47% of the patients in the ceftibuten group and by 38% in the norfloxacin group. This difference was not significant, but diarrhoea or loose stools occurred more frequently in the ceftibuten group.

Topics: Acute Disease; Administration, Oral; Adult; Aged; Aged, 80 and over; Anti-Infective Agents; Ceftibuten; Cefuroxime; Cephalosporins; Double-Blind Method; Drug Therapy, Combination; Escherichia coli; Escherichia coli Infections; Female; Humans; Injections, Intravenous; Male; Middle Aged; Norfloxacin; Prospective Studies; Pyelonephritis; Recurrence; Treatment Outcome

The available oral third generation of cephalosporin, "ceftibuten" was used to substitute the intravenous drug after defervescence in acute pyelonephritis in children. This randomized controlled study compared the efficacy of an oral ceftibuten switch therapy with a ceftriaxone in both short-term and long-term outcomes. 36 99mTc-dimercaptosuccinic acid (DMSA) scan proved pyelonephritis patients were randomized into the study group, "ceftibuten" (N=18) and the control group, "ceftriaxone" (N=18). Ceftriaxone (75 mg/kg/day) was the initial antibiotic in both groups. After defervescence for 24-48 hours, oral ceftibuten (9 mg/kg/day) was substituted in the study group and continued for 10 days. The subject characteristics and laboratory data were not different between the two groups. The urine culture at D14 was sterilized in both groups. The incidence of renal scarring was 66.6 per cent and 61.1 per cent in the study group and the control group respectively. The rate of recurrent infection showed no statistical significance. The duration of hospitalization was shorter in the study group than in the control. In conclusion, oral ceftibuten switch therapy can be recommended as a safe and effective treatment for acute pyelonephritis in children. The use of oral therapy may result in a significant reduction of health care expenditure.

Topics: Acute Disease; Administration, Oral; Adolescent; Ceftibuten; Ceftriaxone; Cephalosporins; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Infant; Infant, Newborn; Injections, Intravenous; Male; Prospective Studies; Pyelonephritis; Reference Values; Treatment Outcome