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

This study has been terminated.
(other upcoming studies; patients refusal of invasive follow up (DMSA))
Sponsor:
Information provided by (Responsible Party):
Marzia Lazzerini, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT00724256
First received: July 18, 2008
Last updated: February 15, 2012
Last verified: February 2012

July 18, 2008
February 15, 2012
July 2006
July 2009   (final data collection date for primary outcome measure)
Rate of renal SCAR [ Time Frame: 6-12 month from urinary tract infection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00724256 on ClinicalTrials.gov Archive Site
  • Relapses [ Time Frame: up to12 months ] [ Designated as safety issue: No ]
  • Adverse effects of drug therapy [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Short-term Antibiotic Therapy for Pyelonephritis in Childhood
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pyelonephritis
  • Drug: ceftibuten
    ceftibuten 9mg/kg once a day for 7 days.
  • Drug: ceftibuten
    ceftibuten 9mg/kg once a day for 10 days.
  • Experimental: 1
    Intervention: Drug: ceftibuten
  • Active Comparator: 2
    Intervention: Drug: ceftibuten
Hodson EM, Willis NS, Craig JC. Antibiotics for acute pyelonephritis in children. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003772. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
36
July 2010
July 2009   (final data collection date for primary outcome measure)

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).
Both
1 Month to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00724256
UTI_62-2006
Yes
Marzia Lazzerini, IRCCS Burlo Garofolo
IRCCS Burlo Garofolo
Not Provided
Study Director: Marzia Lazzerini, MD DTMH IRCCS Burlo Garofolo
IRCCS Burlo Garofolo
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP