Status:

TERMINATED

Short-term Antibiotic Therapy for Pyelonephritis in Childhood

Lead Sponsor:

IRCCS Burlo Garofolo

Conditions:

Pyelonephritis

Eligibility:

All Genders

1-5 years

Phase:

PHASE3

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 n...

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 considere...

Eligibility Criteria

Inclusion

  • Children aged 1 month to 5 years, with a first episode of pyelonephritis.

Exclusion

  • 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).

Key Trial Info

Start Date :

July 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2010

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT00724256

Start Date

July 1 2006

End Date

July 1 2010

Last Update

February 17 2012

Active Locations (1)

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Institute for Child Health Burlo Garofolo

Trieste, Triest, Italy, 34137