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

Phase 4

Completed

• Conditions: Pyelonephritis
• Interventions: Drug: antibiotics; Drug: antibiotic

• Registration Number: NCT00136656
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-26
• Study First Submitted QC: 2005-08-26
• Study First Posted: 2005-08-29
• Primary Completion: 2008-06
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-11
• Last Update Posted: 2009-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	antibiotics	ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days
1	antibiotic	cefixime antibiotic treatment by oral route

Primary Outcome Measures

Name	Time	Method
Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months	between six and eight months

Secondary Outcome Measures

Name	Time	Method
Time to get apyrexia	4 days
Incidence of urologic abnormalities on cystourethrography done during the first month after the infection	one month

Trial Locations

Locations (12)

Hopital Pellegrin; 🇫🇷 Bordeaux, France

Chu de Limoges; 🇫🇷 Limoges, France

Hôpital Antoine Beclere; 🇫🇷 Clamart, France

Hôpital Ambroise Pare; 🇫🇷 Boulogne, France

Hopital de Bicetre; 🇫🇷 Bicetre, France

La Timone; 🇫🇷 Marseille, France

CHU NICE; 🇫🇷 Nice, France

Necker Enfants Malades; 🇫🇷 Paris, France

Saint Vincent de Paul; 🇫🇷 Paris, France

Robert Debre; 🇫🇷 Paris, France

Hôpital Armand Trousseau; 🇫🇷 Paris, France

Hopital Andre Mignot; 🇫🇷 Versailles, France