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Short-term Antibiotic Therapy for Pyelonephritis in Childhood (STUTI)

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ClinicalTrials.gov Identifier: NCT00724256
Recruitment Status : Terminated (other upcoming studies; patients refusal of invasive follow up (DMSA))
First Posted : July 29, 2008
Last Update Posted : February 17, 2012
Information provided by (Responsible Party):
Marzia Lazzerini, IRCCS Burlo Garofolo

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.

Condition or disease Intervention/treatment Phase
Pyelonephritis Drug: ceftibuten Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial on Efficacy and Safety of Short Term Versus Long Term Antibiotic Therapy for Pyelonephritis in Childhood.
Study Start Date : July 2006
Primary Completion Date : July 2009
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: ceftibuten
ceftibuten 9mg/kg once a day for 7 days.
Active Comparator: 2 Drug: ceftibuten
ceftibuten 9mg/kg once a day for 10 days.

Primary Outcome Measures :
  1. Rate of renal SCAR [ Time Frame: 6-12 month from urinary tract infection ]

Secondary Outcome Measures :
  1. Relapses [ Time Frame: up to12 months ]
  2. Adverse effects of drug therapy [ Time Frame: 10 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724256

Institute for Child Health Burlo Garofolo
Triest, Italy, 34137
Sponsors and Collaborators
IRCCS Burlo Garofolo
Study Director: Marzia Lazzerini, MD DTMH IRCCS Burlo Garofolo

Responsible Party: Marzia Lazzerini, MD, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT00724256     History of Changes
Other Study ID Numbers: UTI_62-2006
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Keywords provided by Marzia Lazzerini, IRCCS Burlo Garofolo:
Urinary Tract Infections.
Randomised controlled trial.

Additional relevant MeSH terms:
Nephritis, Interstitial
Kidney Diseases
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents