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

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.

Conditions

• Pyelonephritis

Interventions

DRUG

antibiotic

cephalosporine by oral route : cefixime

DRUG

antibiotics

cephalosporine : ceftriaxone by intra venous route and cefixime by oral route

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• CHERON GERARD, MD · Hôpital Necker Enfants Malades Assistance Publique Hôpitaux de Paris - René Descartes University Paris 5

• CHEVALLIER BERTRAND, MD · Ambroise Paré Hospital, Assistance Publique Hôpitaux de Paris

• GAJDOS VINCENT, MD · Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris

• LABRUNE PHILIPPE, MD · Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris

• GRIMPREL EMMANUEL, MD · Trousseau Hospital AP HP

• DESCHENES GEORGES, MD · TROUSSEAU HOSPITAL AP-HP

• SERGENT ALINE, MD · TROUSSEAU HOSPITAL AP-HP

• VAYLET CLAIRE, MD · TROUSSEAU HOSPITAL AP-HP

• BADER MEUNIER BRIGITTE, MD · BICETRE HOSPITAL AP-HP

• GUIGONIS VINCENT, MD · DUPUYTREN HOSPITAL CHU LIMOGES

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-07-31

Primary Completion

2008-06-30

Completion

2009-02-28

Countries

• France

Study Locations