Randomised controlled trial on efficacy and safety of short term versus long term antibiotic therapy for pyelonephritis in childhood. - Short term antibiotic therapy for pyelonephritis in childhood.
- Conditions
- Acute pyelonephritisMedDRA version: 9.1Level: LLTClassification code 10037596Term: Pyelonephritis
- Registration Number
- EUCTR2008-003209-16-IT
- Lead Sponsor
- ISTITUTO PER L'INFANZIA BURLO GAROFOLO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Children aged 1 month to 5 years, with a first episode of upper urinary infection (pyelonephritis).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method