Study Stopped
other upcoming studies; patients refusal of invasive follow up (DMSA)
Short-term Antibiotic Therapy for Pyelonephritis in Childhood
STUTI
Randomised Controlled Trial on Efficacy and Safety of Short Term Versus Long Term Antibiotic Therapy for Pyelonephritis in Childhood.
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2006
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 18, 2008
CompletedFirst Posted
Study publicly available on registry
July 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFebruary 17, 2012
February 1, 2012
3 years
July 18, 2008
February 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of renal SCAR
6-12 month from urinary tract infection
Secondary Outcomes (2)
Relapses
up to12 months
Adverse effects of drug therapy
10 days
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Children aged 1 month to 5 years, with a first episode of pyelonephritis.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Child Health Burlo Garofolo
Trieste, Triest, 34137, Italy
Related Publications (1)
Hodson EM, Willis NS, Craig JC. Antibiotics for acute pyelonephritis in children. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003772. doi: 10.1002/14651858.CD003772.pub3.
PMID: 17943796BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marzia Lazzerini, MD DTMH
IRCCS Burlo Garofolo
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 18, 2008
First Posted
July 29, 2008
Study Start
July 1, 2006
Primary Completion
July 1, 2009
Study Completion
July 1, 2010
Last Updated
February 17, 2012
Record last verified: 2012-02