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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00136656

Collaborator

(none)

700

Enrollment

Locations

Arms

43.1

Duration (Months)

58.3

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pyelonephritis	Drug: antibiotic Drug: antibiotics	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

700 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 cefixime antibiotic treatment by oral route	Drug: antibiotic cephalosporine by oral route : cefixime
Sham Comparator: 2 ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days	Drug: antibiotics cephalosporine : ceftriaxone by intra venous route and cefixime by oral route

Arm

Intervention/Treatment

Active Comparator: 1

cefixime antibiotic treatment by oral route

Drug: antibiotic

cephalosporine by oral route : cefixime

Sham Comparator: 2

ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days

Drug: antibiotics

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

Outcome Measures

Primary Outcome Measures

Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months [between six and eight months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 3 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hopital de Bicetre	Bicetre	France	94275
2	Hopital Pellegrin	Bordeaux	France	33000
3	Hôpital Ambroise Pare	Boulogne	France	92100
4	Hôpital Antoine Beclere	Clamart	France	92141
5	Chu de Limoges	Limoges	France	87042
6	La Timone	Marseille	France	13385
7	CHU NICE	Nice	France	06000
8	Saint Vincent de Paul	Paris	France	75014
9	Necker Enfants Malades	Paris	France	75015
10	Robert Debre	Paris	France	75019
11	Hôpital Armand Trousseau	Paris	France	75571
12	Hopital Andre Mignot	Versailles	France	78150

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: CHERON GERARD, MD, Hôpital Necker Enfants Malades Assistance Publique Hôpitaux de Paris - René Descartes University Paris 5
Study Chair: CHEVALLIER BERTRAND, MD, Ambroise Paré Hospital, Assistance Publique Hôpitaux de Paris
Study Chair: GAJDOS VINCENT, MD, Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris
Study Chair: LABRUNE PHILIPPE, MD, Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris
Study Chair: GRIMPREL EMMANUEL, MD, Trousseau Hospital AP HP
Study Chair: DESCHENES GEORGES, MD, TROUSSEAU HOSPITAL AP-HP
Study Chair: SERGENT ALINE, MD, TROUSSEAU HOSPITAL AP-HP
Study Chair: VAYLET CLAIRE, MD, TROUSSEAU HOSPITAL AP-HP
Study Chair: BADER MEUNIER BRIGITTE, MD, BICETRE HOSPITAL AP-HP
Study Chair: GUIGONIS VINCENT, MD, DUPUYTREN HOSPITAL CHU LIMOGES