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

Pyelonephritis Clinical Trial

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. Multicenter, Randomised Trial of Equivalence.

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pyelonephritis

• NCT number: NCT00136656
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Phase: Phase 4
• Start date: July 2005
• Completion date: February 2009