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