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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
700
cephalosporine by oral route : cefixime
cephalosporine : ceftriaxone by intra venous route and cefixime by oral route
Hopital de Bicetre
Bicêtre, France
Hopital Pellegrin
Bordeaux, France
Hôpital Ambroise Pare
Boulogne, France
Hôpital Antoine Beclere
Clamart, France
Chu de Limoges
Limoges, France
La Timone
Marseille, France
CHU NICE
Nice, France
Saint Vincent de Paul
Paris, France
Necker Enfants Malades
Paris, France
Robert Debre
Paris, France
...and 2 more locations
Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months
Time frame: between six and eight months
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
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