NCT00136656

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 1 Month – 3 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Pyelonephritis

Interventions

Type	Name	Description
DRUG	antibiotic	cephalosporine by oral route : cefixime
DRUG	antibiotics	cephalosporine : ceftriaxone by intra venous route and cefixime by oral route

Timeline

• Start date: 2005-07-01
• Primary completion: 2008-06-01
• Completion: 2009-02-01
• First posted: 2005-08-29
• Last updated: 2009-02-12

Locations

12 sites across 1 country: France