Short-term Antibiotic Therapy for Pyelonephritis in Childhood

• Status: Terminated
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Burlo Garofolo
• Treatments: Anti-Bacterial Agents; Ceftibuten; Cephalosporins

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).