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

Purpose

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.

Condition	Intervention	Phase
Pyelonephritis	Drug: antibiotic Drug: antibiotics	Phase IV

MedlinePlus related topics:

Antibiotics Scars

ChemIDplus related topics:

Ceftriaxone Ceftriaxone Sodium Cefixime Succimer

U.S. FDA Resources

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

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.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months [ Time Frame: between six and eight months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to get apyrexia [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
Incidence of urologic abnormalities on cystourethrography done during the first month after the infection [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	700
Study Start Date:	July 2005
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator cefixime antibiotic treatment by oral route	Drug: antibiotic cephalosporine by oral route : cefixime
2: Sham Comparator 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

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136656

Contacts


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

Contact: PETIT Olivier	33 1 44 49 59 54	olivier.petit@nck.ap-hop-paris.fr

Locations


France
	Necker Enfants Malades	Recruiting
	PARIS, France, 75015
	Contact: CHERON GERARD, MD 33 1 44 49 42 92 gerard.cheron@nck.ap-hop-paris.fr
	Contact: SALOMON REMI, MD 33 1 44 49 42 90 remi.salomon@nck.ap-hop-paris.fr
	Sub-Investigator: bocquet nathalie, md
	Sub-Investigator: garel denis, md
	Sub-Investigator: chappuy helene, md
	Sub-Investigator: faesch sabine, md
	Sub-Investigator: wille chrystel, md
	Sub-Investigator: chalouhi chrystel, md
	Sub-Investigator: cojocaru bogdan, md
	Sub-Investigator: timsit sandra, md
	Principal Investigator: CHERON GERARD, MD
	Sub-Investigator: Valérie NOUYRIGAT, MD
	Robert Debre	Not yet recruiting
	PARIS, France, 75019
	Contact: VITOUX-BROT CHRISTINE, MD 33 1 40 03 20 00 christine.vitoux@rdb.ap-hop-paris.fr
	Contact: HOLVOET LAURENT, MD 33 1 40 03 20 00 laurent.holvoet@rdb.ap-hop-paris.fr
	Principal Investigator: VITOUX-BROT CHRISTINE, MD
	Sub-Investigator: HOLVOET LAURENT, MD
	Saint Vincent De Paul	Not yet recruiting
	PARIS, France, 75014
	Contact: GENDREL DOMINIQUE, MD 33 1 40 48 81 11 dominique.gendrel@svp.ap-hop-paris.fr
	Contact: CHALUMEAU MARTIN, MD 33 1 40 48 81 11 martin.chalumeau@wanadoo.fr
	Sub-Investigator: MOULIN FLORENCE, MD
	Sub-Investigator: BISCARDI SANDRA, MD
	Sub-Investigator: DE SUREMAIN NATHALIE, MD
	Sub-Investigator: MARC ELISABETH, MD
	Principal Investigator: GENDREL DOMINIQUE, MD
	Sub-Investigator: CHALUMEAU MARTIN, MD
	Hopital Andre Mignot	Not yet recruiting
	VERSAILLES, France, 78150
	Contact: FOUCAUD PIERRE, MD 33 1 39 63 91 33 p.foucaud@ch-versailles.fr
	Contact: NATHANSON SYLVIE, MD 33 1 39 63 91 33 sylvie.nathanson@ch-versailles.fr
	Principal Investigator: FOUCAUD PIERRE, MD
	Sub-Investigator: NATHANSON SYLVIE, MD
	Sub-Investigator: DOMMERGUES MARIE ALIETTE, MD
	Hopital Pellegrin	Not yet recruiting
	BORDEAUX, France, 33000
	Contact: LLANAS BRIGITTE, MD 33 5 56 79 56 79 brigitte.llanas@chu-bordeaux.fr
	Contact: PEDESPAN LAURENCE, MD 33 5 56 79 56 79 laurence.pedespan@chu-bordeaux.fr
	Principal Investigator: LLANAS BRIGITTE, MD
	Sub-Investigator: PEDESPAN LAURENCE, MD
	Sub-Investigator: PILLET PASCAL, MD
	Sub-Investigator: BARAT PASCAL, MD
	Sub-Investigator: RICHER PASCAL, MD
	Sub-Investigator: VAUTIER VANESSA, MD
	Chu De Limoges	Not yet recruiting
	LIMOGES, France, 87042
	Contact: GUIGONIS VINCENT, MD 33 1 5 55 05 68 67 vincent.guigonis@chu-limoges.fr
	Contact: LIENHARDT ANNE, MD 33 1 5 55 05 68 67 anne.lienhardt@chu-limoges.fr
	Principal Investigator: GUIGONIS VINCENT, MD
	Sub-Investigator: LIENHARDT ANNE, MD
	Sub-Investigator: AGUDZE ETIENNE, MD
	Sub-Investigator: BEDU ANTOINE, MD
	Sub-Investigator: BROSSET PHILIPPE, MD
	Sub-Investigator: BROUET DELPHINE, MD
	Sub-Investigator: CONSTANTY ANNE, MD
	Sub-Investigator: KETTERER SOPHIE, MD
	Sub-Investigator: LANGUEPIN JANE, MD
	Sub-Investigator: LAROCHE CECILE, MD
	Sub-Investigator: RIBEIRA-CANO ANNA, MD
	Sub-Investigator: MENETREY CELINE, MD
	Sub-Investigator: MESSAGER VERONIQUE, MD
	Sub-Investigator: PIGUET CHRISTOPHE, MD
	Sub-Investigator: THON SEVERINE, MD
	Sub-Investigator: Caroline OUDOT, MD
	HÔPITAL Ambroise Pare	Not yet recruiting
	Boulogne, France, 92100
	Contact: CHEVALLIER BERTRAND, MD 33 1 49 09 50 00 bertrand.chevallier@apr.ap-hop-paris.fr
	Contact: STHENEUR CHANTAL, MD 33 1 49 09 50 00 chantal.stheneur@apr.ap-hop-paris.fr
	Principal Investigator: CHEVALLIER BERTRAND, MD
	Sub-Investigator: STHENEUR CHANTAL, MD
	Sub-Investigator: BERARD LAURENCE, MD
	Sub-Investigator: DE GONNEVILLE AGNES, MD
	Sub-Investigator: EL AMMAR ZAKI
	Sub-Investigator: GIACCOBI VANINA, MD
	Sub-Investigator: LESPRIT EMMANUELLE, MD
	Sub-Investigator: PAYCHA FREDERIC, MD
	Sub-Investigator: Valérie SOUSSAN, MD
	CHU NICE	Not yet recruiting
	NICE, France, 06000
	Contact: HAAS HERVE, MD 33 4 92 03 61 73 haas.h@chu-nice.fr
	Contact: BERLIOZ MICHELE, MD 33 4 92 03 62 71 berlioz.m@chu-nice.fr
	Principal Investigator: HAAS HERVE, MD
	Sub-Investigator: BERLIOZ MICHELE, MD
	Sub-Investigator: MAS JEAN CHRISTOPHE, MD
	Sub-Investigator: TRIOLO VALERIE, MD
	Hopital De Bicetre	Not yet recruiting
	BICETRE, France, 94275
	Contact: BADER-MEUNIER BRIGITTE, MD 33 1 45 21 21 21 brigitte.bader-meunier@bct.ap-hop-paris.fr
	Sub-Investigator: DECOBERT MARION, MD
	Sub-Investigator: FERIAL ARNAUD, MD
	Sub-Investigator: GUITON CORINNE, MD
	Sub-Investigator: KELFAOUI FATIMA, MD
	Sub-Investigator: KHOURY WAFA, MD
	Sub-Investigator: LOROTTE STEPHANIE, MD
	Sub-Investigator: LYKAVIERIS PANAYOTIS, MD
	Sub-Investigator: MEDJAEL NADIA, MD
	Sub-Investigator: MEURIC STEPHANIE, MD
	Sub-Investigator: NOUYRIGAT VALERIE
	Principal Investigator: BADER-MEUNIER BRIGITTE, MD
	Principal Investigator: ARCHAMBAUD FREDERIQUE, MD
	HÔPITAL Armand Trousseau	Not yet recruiting
	Paris, France, 75571
	Contact: GRIMPREL EMMANUEL, MD 33 1 44 73 69 01 emmanuel.grimprel@trs.ap-hop-paris.fr
	Contact: DESCHENES GEORGES, MD 33 1 44 73 69 01 georges.deschenes@trs.ap-hop-paris.fr
	Sub-Investigator: CASTELO BEATRICE, MD
	Sub-Investigator: COSTEIRA CHRISTINE, MD
	Sub-Investigator: DELAMAR ANNE-LISE
	Sub-Investigator: ELANDALOUSSI BECHERKI, MD
	Sub-Investigator: KRAYEM LINA, MD
	Sub-Investigator: LASSERE SABINE, MD
	Sub-Investigator: MAMAN LINDA, MD
	Sub-Investigator: MANDELCWAJG ALEXIS, MD
	Sub-Investigator: PAREZ NATHALIE, MD
	Principal Investigator: SERGENT ALINE, MD
	Principal Investigator: VAYLET CLAIRE, MD
	Principal Investigator: GRIMPREL EMMANUEL, MD
	Principal Investigator: DESCHENES GEORGES, MD
	HÔPITAL Antoine Beclere	Recruiting
	CLAMART, France, 92141
	Contact: GAJDOS VINCENT, MD 33 1 45 37 44 44 vincent.gajdos@abc.ap-hop-paris.fr
	Contact: LABRUNE PHILIPPE, MD 33 1 45 37 44 44 philippe.labrune@abc.ap-hop-paris.fr
	Sub-Investigator: BOON GUILLAUME, MD
	Sub-Investigator: CLECH LAURE, MD
	Sub-Investigator: COUSIN MARIE-NOELLE, MD
	Sub-Investigator: MOLLET-BOUDJEMLINE ALIX, MD
	Sub-Investigator: SCHEID ANNETTE, MD
	Sub-Investigator: TRIOCHE-EBERSCHWEILER PASCALE, MD
	Principal Investigator: GAJDOS VINCENT, MD
	Principal Investigator: LABRUNE PHILIPPE, MD
	Principal Investigator: PERREAUX FRANCIS, MD
	LA TIMONE	Not yet recruiting
	MARSEILLE, France, 13385
	Contact: LE HORS HELENE, MD 33 4 91 38 66 82 helene.lehors@mail.ap-hm.fr
	Contact: TSIMARATOS MICHEL, MD 33 4 91 38 67 42 michel.tsimaratos@ap-hm.fr
	Principal Investigator: LEHORS HELENE, MD
	Sub-Investigator: TSIMARATOS MICHEL, MD
	Sub-Investigator: BREMOND VALERIE, MD
	Sub-Investigator: BRUNO DANIELLE, MD
	Sub-Investigator: COSTE MARIE EDITH, MD
	Sub-Investigator: GIRAUD PATRICIA, MD
	Sub-Investigator: LESCURE PHILIPPE, MD
	Sub-Investigator: LUC CAROLINE, MD
	Sub-Investigator: PORTAS MICHELE, MD
	Sub-Investigator: Mathilde CAILLIEZ, MD

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

Ages Eligible for Study:	1 Month to 3 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Responsible Party:	Department Clinical Reearch of Developpement ( Thérèse NGOUE )
Study ID Numbers:	P040422, AOM 04 105
First Received:	August 26, 2005
Last Updated:	January 16, 2008
ClinicalTrials.gov Identifier:	NCT00136656
Health Authority:	France: Ministry of Health

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00136656