Clinical Trial: Short-term Antibiotic Therapy for Pyelonephritis in Childhood
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Randomised Controlled Trial on Efficacy and Safety of Short Term Versus Long Term Antibiotic Therapy for Pyelonephritis in Childhood.
Brief Summary:
The purpose of this study is to evaluate the efficacy of oral ceftibuten for 7 days versus 10 days in acute pyelonephritis in children.
The main hypothesis is that the ceftibuten for 7 days will be not inferior to ceftibuten 10 days in the rate of renal scarring at 6-12 months.
Detailed Summary:
Acute pyelonephritis is one of the most common serious bacterial infections in childhood, particularly in young children, with an estimated prevalence in febrile infants of 5.3%. It has been considered an important risk factor for the development of renal scarring, and renal insufficiency. More recently the long term outcomes of pyelonephritis has ameliorated, probably because of prompt diagnosis and therapy, and the importance of urinary tract infection as a risk factor for renal insufficiency has been questioned.
Nevertheless, the optimal type and duration of antibiotic therapy for acute uncomplicated pyelonephritis in children is not established yet.
There is a general agreement that children who are dehydrated, unable to drink, or in whom sepsis is possible, should be admitted to hospital for intravenous antibiotic treatment.
Outside this conditions, evidence suggest that children with acute pyelonephritis can be treated effectively with cefixime, ceftibuten or amoxycillin/clavulanic acid. given orally (1).
A recently updated Cochrane review on antibiotic treatment for acute pyelonephritis in children identified twenty three studies (3407 children). No significant differences were found in persistent renal damage at six to 12 months (824 children: RR 0.80, 95% CI 0.50 to 1.26) or in duration of fever (808 children: WMD 2.05, 95% CI -0.84 to 4.94) between oral antibiotic therapy (10 to 14 days) and IV therapy (3 days) followed by oral therapy (10 days). Similarly no significant differences in persistent renal damage (3 studies, 341 children: RR 1.13, 95% CI 0.86 to 1.49) were found between IV therapy (3 to 4 days) followed by oral therapy and IV therapy for 7 to 14 days.
A
Sponsor: IRCCS Burlo Garofolo
Current Primary Outcome: Rate of renal SCAR [ Time Frame: 6-12 month from urinary tract infection ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Relapses [ Time Frame: up to12 months ]
- Adverse effects of drug therapy [ Time Frame: 10 days ]
Original Secondary Outcome: Same as current
Information By: IRCCS Burlo Garofolo
Dates:
Date Received: July 18, 2008
Date Started: July 2006
Date Completion:
Last Updated: February 15, 2012
Last Verified: February 2012
