Pyelonephritis Clinical Trial
— STUTIOfficial title:
Randomised Controlled Trial on Efficacy and Safety of Short Term Versus Long Term Antibiotic Therapy for Pyelonephritis in Childhood.
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.
Status | Terminated |
Enrollment | 36 |
Est. completion date | July 2010 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 5 Years |
Eligibility |
Inclusion Criteria: - Children aged 1 month to 5 years, with a first episode of pyelonephritis. Exclusion Criteria: - Children less than 1 month, or older than 5 years. - Relapse of pyelonephritis. - Sepsis and/or vomiting, or other conditions where it's impossible to administer an oral therapy. - Allergy to ceftibuten. - Previous antibiotic therapy for the same infection. - Long term antibiotic prophylaxis with an antibiotic of the same class, if laboratory antibiotic resistance is shown. - Children with uncontrolled other disease. - Complicated pyelonephritis (abscess). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Institute for Child Health Burlo Garofolo | Triest |
Lead Sponsor | Collaborator |
---|---|
IRCCS Burlo Garofolo |
Italy,
Hodson EM, Willis NS, Craig JC. Antibiotics for acute pyelonephritis in children. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003772. Review. Update in: Cochrane Database Syst Rev. 2014;7:CD003772. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of renal SCAR | 6-12 month from urinary tract infection | No | |
Secondary | Relapses | up to12 months | No | |
Secondary | Adverse effects of drug therapy | 10 days | Yes |
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