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 (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 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: May 2008

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.

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 IV treatments.

Intervention(s) in this Clinical Trial

• Drug: antibiotic
  • cephalosporine by oral route : cefixime
• Drug: antibiotics
  • cephalosporine : ceftriaxone by intra venous route and cefixime by oral route

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • cefixime antibiotic treatment by oral route
• Sham Comparator: 2
  • ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days

Primary Measures

• Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months
  • Time Frame: between six and eight months
    Safety Issue?: No

Secondary Measures

• Time to get apyrexia
  • Time Frame: 4 days
    Safety Issue?: Yes
• Incidence of urologic abnormalities on cystourethrography done during the first month after the infection
  • Time Frame: one month
    Safety Issue?: Yes

Inclusion Criteria:

• Infants and children more than 1 month old and less than 3 years old
• First episode of acute pyelonephritis with gram negative strains
• Fever more than 38.5°C
• Procalcitonin (PCT) value > 0.5 ng/ml
• Urine obtained by transurethral bladder catheterization, suprapubic aspiration or midstream collection
• Urine exam: more than 100.000 leukocytes and gram negative strains +
• Normal hemodynamic exam
• Normal renal ultrasonography
• Positive DMSA renal scan for pyelonephritis during the first week after diagnosis
• Parental informed consent

Exclusion Criteria:

• Newborn
• Children more than 3 years old
• Past urine infection
• Septic hemodynamic abnormalities
• Obstructive uropathy and any renal ultrasonography abnormalities
• Allergy to cefixime or ceftriaxone
• Antibiotic during the five previous days
• Gastrointestinal abnormalities able to interfere with antibiotic intake or absorption
• Absence of parental consent
• Social familial difficulties

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Month

Maximum Age for this Clinical Trial: 3 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Overall Clinical Trial Officials and Contacts

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

Overall Contact: LANDAIS PAUL, MD, PHD 33 1 44 49 46 14 paul.landais@nck.aphp.fr

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00136656

Study ID Number: P040422

ClinicalTrials.gov Identifier: NCT00136656

Health Authority: France: Ministry of Health