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
  Purpose

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 Intervention Phase
Pyelonephritis
Drug: ceftibuten
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by IRCCS Burlo Garofolo:

Primary Outcome Measures:
  • Rate of renal SCAR [ Time Frame: 6-12 month from urinary tract infection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: July 2006
Study Completion Date: July 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   1 Month to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724256

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

Publications:
Responsible Party: Marzia Lazzerini, MD, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT00724256     History of Changes
Other Study ID Numbers: UTI_62-2006
Study First Received: July 18, 2008
Last Updated: February 15, 2012
Health Authority: Italy: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by IRCCS Burlo Garofolo:
Pyelonephritis.
Urinary Tract Infections.
Children.
Randomised controlled trial.
Therapy.
Ceftibuten.

Additional relevant MeSH terms:
Pyelonephritis
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis
Anti-Bacterial Agents
Ceftibuten
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 24, 2014