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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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.

Italy1 site
  • Institute for Child Health Burlo Garofolo

    Trieste, Triest, 34137

Other trials in Italy

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 groups in NCT00724256
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: ceftibuten
2Active comparatorNot described
Receives: Drug: ceftibuten

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of renal SCAR

    Measured: 6-12 month from urinary tract infection

Secondary outcomes (2)
  1. Relapses

    Measured: up to12 months

  2. 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.

  1. First posted29 Jul 2008 (estimated)
  2. Study startJul 2006
  3. Primary completionJul 2009
  4. Study completionJul 2010

Why it stopped: other upcoming studies; patients refusal of invasive follow up (DMSA)

Resources

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)
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

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.

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