PyelonephritisPhase 3STUTINCT00724256
Short-term Antibiotic Therapy for Pyelonephritis in Childhood
A Phase 3 study testing ceftibuten in people with Pyelonephritis, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Pyelonephritis
- What is being tested?
- ceftibuten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2006to Jul 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 month to 5 years, with a first episode of pyelonephritis.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read the detailed description
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.
Authors concluded that children with acute pyelonephritis can be treated effectively with oral antibiotics (cefixime, ceftibuten and amoxycillin/clavulanic acid) or with short courses (2 to 4 days) of IV therapy followed by oral therapy.
Oral treatment also is easier to use and does not require admission to hospital, leading to reduced costs.
Nevertheless, the exact duration of oral therapy is not established. Current guidelines recommend 7-14 days course of broad-spectrum antibiotics capable of reaching significant renal levels.
The objective of our study is to evaluate if oral ceftibuten for 7 days is equally effective as oral ceftibuten for 10 days in acute pyelonephritis in children.
This is a non-inferiority randomised controlled trial to determine whether a short term therapy with ceftibuten ( 7 days) will be therapeutically similar to a long term therapy ( 10 days), measuring as major outcome the prevalence of renal scars.
- Conditions
- Pyelonephritis
- Being tested
- ceftibuten
- Keywords
- Pyelonephritis., Urinary Tract Infections., Children., Randomised controlled trial., Therapy., Ceftibuten.
- Medical subject headings
- Pyelonephritis, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftibutenDrug
ceftibuten 9mg/kg once a day for 7 days.
ceftibutenDrug
ceftibuten 9mg/kg once a day for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ceftibuten |
| 2 | Active comparator | Not described Receives: Drug: ceftibuten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of renal SCAR
Measured: 6-12 month from urinary tract infection
Secondary outcomes (2)
Relapses
Measured: up to12 months
Adverse effects of drug therapy
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJul 2006
- Primary completionJul 2009
- Study completionJul 2010
Why it stopped: other upcoming studies; patients refusal of invasive follow up (DMSA)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PyelonephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marzia Lazzerini, IRCCS Burlo Garofolo
- Investigators
- Marzia Lazzerini, MD DTMH, Study director, IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724256
- Sponsor's protocol ID
- UTI_62-2006
- Acronym
- STUTI
- Status last verified
- Feb 2012
- First submitted
- 18 Jul 2008
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17943796
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial on Efficacy and Safety of Short Term Versus Long Term Antibiotic Therapy for Pyelonephritis in Childhood.
- ClinicalTrials.gov ID
- NCT00724256
- Acronym / sponsor ID
- STUTI / UTI_62-2006
- Conditions
- Pyelonephritis
- Keywords
- Pyelonephritis., Urinary Tract Infections., Children., Randomised controlled trial., Therapy., Ceftibuten.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: other upcoming studies; patients refusal of invasive follow up (DMSA)
- Enrolment
- 36 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Authors concluded that children with acute pyelonephritis can be treated effectively with oral antibiotics (cefixime, ceftibuten and amoxycillin/clavulanic acid) or with short courses (2 to 4 days) of IV therapy followed by oral therapy.
Oral treatment also is easier to use and does not require admission to hospital, leading to reduced costs.
Nevertheless, the exact duration of oral therapy is not established. Current guidelines recommend 7-14 days course of broad-spectrum antibiotics capable of reaching significant renal levels.
The objective of our study is to evaluate if oral ceftibuten for 7 days is equally effective as oral ceftibuten for 10 days in acute pyelonephritis in children.
This is a non-inferiority randomised controlled trial to determine whether a short term therapy with ceftibuten ( 7 days) will be therapeutically similar to a long term therapy ( 10 days), measuring as major outcome the prevalence of renal scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ceftibuten |
| 2 | Active comparator | Drug: ceftibuten |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 1 month to 5 years, with a first episode of pyelonephritis.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceftibutenceftibuten 9mg/kg once a day for 7 days. | Drug | 1 |
| ceftibutenceftibuten 9mg/kg once a day for 10 days. | Drug | 2 |
Primary outcome
Rate of renal SCAR
Time frame: 6-12 month from urinary tract infection
2 secondary outcomes
Relapses
Time frame: up to12 months
Adverse effects of drug therapy
Time frame: 10 days
Results and safety
The study was stopped early (reason given: other upcoming studies; patients refusal of invasive follow up (DMSA)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
- Background: PubMed 17943796Hodson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marzia Lazzerini, MD DTMH study director
IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ceftibuten in people with Pyelonephritis, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: other upcoming studies; patients refusal of invasive follow up (DMSA)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of renal SCAR (time frame: 6-12 month from urinary tract infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00724256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.