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.

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.

Study Overview

• Status: Terminated
• Conditions: Pyelonephritis
• Intervention / Treatment: Drug: ceftibuten; Drug: ceftibuten

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
• Enrollment (Actual): 36
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Triest, Italy, 34137
    • Institute for Child Health Burlo Garofolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 2	Drug: ceftibuten; ceftibuten 9mg/kg once a day for 7 days.; Drug: ceftibuten; ceftibuten 9mg/kg once a day for 10 days.
EXPERIMENTAL: 1	Drug: ceftibuten; ceftibuten 9mg/kg once a day for 7 days.; Drug: ceftibuten; ceftibuten 9mg/kg once a day for 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of renal SCAR	6-12 month from urinary tract infection

Secondary Outcome Measures

Outcome Measure	Time Frame
Relapses	up to12 months
Adverse effects of drug therapy	10 days

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Director: Marzia Lazzerini, MD DTMH, IRCCS Burlo Garofolo

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: July 18, 2008
• First Submitted That Met QC Criteria: July 25, 2008
• First Posted (ESTIMATE): July 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 17, 2012
• Last Update Submitted That Met QC Criteria: February 15, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Randomised controlled trial.; Children.; Therapy.; Pyelonephritis.; Urinary Tract Infections.; Ceftibuten.
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Nephritis; Nephritis, Interstitial; Pyelitis; Pyelonephritis; Anti-Infective Agents; Anti-Bacterial Agents; Ceftibuten
• Other Study ID Numbers: UTI_62-2006