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

This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, October 2006

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

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

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
  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    
  More Information

Publications:

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
infant  
children  
pyelonephritis  
Renal scars  
DMSA scan  

Study placed in the following topic categories:
Cephalosporins
Succimer
Urologic Diseases
Nephritis
Pyelonephritis
Cefixime
Ceftriaxone
Kidney Diseases
Cicatrix

Additional relevant MeSH terms:
Nephritis, Interstitial
Pyelitis

ClinicalTrials.gov processed this record on September 05, 2008




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