Clinical Trial: Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old. Cefixime PO 10d vs Ceftriaxone IV 4d Followed by Cefixime PO 6d

Brief Summary:

The purpose of this study is to demonstrate the equivalence of the therapeutic efficacy of cefixime by mouth (PO) 10 days (d) and ceftriaxone intravenous route(IV) 4d followed by cefixime PO 6d on renal scars 6 months after a first acute pyelonephritis episode.

The investigators hypothesize that treatment with cefixime PO will allow no more renal scars than intravenous route (IV) treatment of pyelonephritis in infants and children less than 3 years old, 6 months after the first episode. If it is true, treatment will no longer need hospitalisation and the advantages for children, families and the health system will be very important.


Detailed Summary:

Guidelines for treatment of acute pyelonephritis in infants and children are different from one country to another. The main question is the incidence of renal scars.

intravenous route (IV) treatment is supposed to give the best results, but no previous study has ever given the incidence of renal scars after PO treatment.

This multicenter, randomised trial is an equivalence study of PO and intravenous route (IV) treatments.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months [ Time Frame: between six and eight months ]

Original Primary Outcome: Renal scars on DMSA renal scan at 6 months

Current Secondary Outcome:

  • Time to get apyrexia [ Time Frame: 4 days ]
  • Incidence of urologic abnormalities on cystourethrography done during the first month after the infection [ Time Frame: one month ]


Original Secondary Outcome:

  • Time to get apyrexia
  • Incidence of urologic abnormalities on cystourethrography done during the first month after the the infection


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: August 26, 2005
Date Started: July 2005
Date Completion:
Last Updated: February 11, 2009
Last Verified: February 2009