Clinical trial NCT00136656: Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pyelonephritis
Keywords: infant
children
pyelonephritis
Renal scars
DMSA scan
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-08-29
Enrollment: 700
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months
timeFrame: between six and eight months
Secondary outcomes:
measure: Time to get apyrexia
timeFrame: 4 days
measure: Incidence of urologic abnormalities on cystourethrography done during the first month after the infection
timeFrame: one month
Other outcomes:
Locations:
city: Bicetre
country: France
facility: Hopital de Bicetre
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Boulogne
country: France
facility: Hôpital Ambroise Pare
city: Clamart
country: France
facility: Hôpital Antoine Beclere
city: Limoges
country: France
facility: Chu de Limoges
city: Marseille
country: France
facility: La Timone
city: Nice
country: France
facility: CHU NICE
city: Paris
country: France
facility: Saint Vincent de Paul
city: Paris
country: France
facility: Necker Enfants Malades
city: Paris
country: France
facility: Robert Debre
city: Paris
country: France
facility: Hôpital Armand Trousseau
city: Versailles
country: France
facility: Hopital Andre Mignot
Study officials:
affiliation: Hôpital Necker Enfants Malades Assistance Publique Hôpitaux de Paris - René Descartes University Paris 5
name: CHERON GERARD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ambroise Paré Hospital, Assistance Publique Hôpitaux de Paris
name: CHEVALLIER BERTRAND, MD
role: STUDY_CHAIR
affiliation: Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris
name: GAJDOS VINCENT, MD
role: STUDY_CHAIR
affiliation: Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris
name: LABRUNE PHILIPPE, MD
role: STUDY_CHAIR
affiliation: Trousseau Hospital AP HP
name: GRIMPREL EMMANUEL, MD
role: STUDY_CHAIR
affiliation: TROUSSEAU HOSPITAL AP-HP
name: DESCHENES GEORGES, MD
role: STUDY_CHAIR
affiliation: TROUSSEAU HOSPITAL AP-HP
name: SERGENT ALINE, MD
role: STUDY_CHAIR
affiliation: TROUSSEAU HOSPITAL AP-HP
name: VAYLET CLAIRE, MD
role: STUDY_CHAIR
affiliation: BICETRE HOSPITAL AP-HP
name: BADER MEUNIER BRIGITTE, MD
role: STUDY_CHAIR
affiliation: DUPUYTREN HOSPITAL CHU LIMOGES
name: GUIGONIS VINCENT, MD
role: STUDY_CHAIR
References:
citation: Sannier N, Le Masne A, Sayegh N, Gaillard JL, Cheron G. Ambulatory management of acute pyelonephritis in children. Acta Paediatr. 2000 Mar;89(3):372-3. No abstract available.
citation: Leroy S, Marc E, Adamsbaum C, Gendrel D, Breart G, Chalumeau M. Prediction of vesicoureteral reflux after a first febrile urinary tract infection in children: validation of a clinical decision rule. Arch Dis Child. 2006 Mar;91(3):241-4. doi: 10.1136/adc.2004.068205. Epub 2005 May 12.
citation: Leroy S, Adamsbaum C, Marc E, Moulin F, Raymond J, Gendrel D, Breart G, Chalumeau M. Procalcitonin as a predictor of vesicoureteral reflux in children with a first febrile urinary tract infection. Pediatrics. 2005 Jun;115(6):e706-9. doi: 10.1542/peds.2004-1631. Epub 2005 May 2.
citation: Marc E, Menager C, Moulin F, Stos B, Chalumeau M, Guerin S, Lebon P, Brunet F, Raymond J, Gendrel D. [Procalcitonin and viral meningitis: reduction of unnecessary antibiotics by measurement during an outbreak]. Arch Pediatr. 2002 Apr;9(4):358-64. doi: 10.1016/s0929-693x(01)00793-x. French.
citation: Bocquet N, Sergent Alaoui A, Jais JP, Gajdos V, Guigonis V, Lacour B, Cheron G. Randomized trial of oral versus sequential IV/oral antibiotic for acute pyelonephritis in children. Pediatrics. 2012 Feb;129(2):e269-75. doi: 10.1542/peds.2011-0814. Epub 2012 Jan 30.