NCT00136656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_4

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

2.9 years

First QC Date

August 26, 2005

Last Update Submit

February 11, 2009

Conditions

Pyelonephritis

Keywords

infantchildrenpyelonephritisRenal scarsDMSA scan

Outcome Measures

Primary Outcomes (1)

  • Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months

    between six and eight months

Secondary Outcomes (2)

  • Time to get apyrexia

    4 days

  • Incidence of urologic abnormalities on cystourethrography done during the first month after the infection

    one month

Study Arms (2)

1

ACTIVE COMPARATOR

cefixime antibiotic treatment by oral route

Drug: antibiotic

2

SHAM COMPARATOR

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

Drug: antibiotics

Interventions

antibioticDRUG

cephalosporine by oral route : cefixime

1
antibioticsDRUG

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

2

Eligibility Criteria

Age1 Month - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hopital de Bicetre

Bicêtre, 94275, France

Location

Hopital Pellegrin

Bordeaux, 33000, France

Location

Hôpital Ambroise Pare

Boulogne, 92100, France

Location

Hôpital Antoine Beclere

Clamart, 92141, France

Location

Chu de Limoges

Limoges, 87042, France

Location

La Timone

Marseille, 13385, France

Location

CHU NICE

Nice, 06000, France

Location

Saint Vincent de Paul

Paris, 75014, France

Location

Necker Enfants Malades

Paris, 75015, France

Location

Robert Debre

Paris, 75019, France

Location

Hôpital Armand Trousseau

Paris, 75571, France

Location

Hopital Andre Mignot

Versailles, 78150, France

Location

Related Publications (5)

  • 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.

    PMID: 10772296BACKGROUND

  • 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.

    PMID: 15890693BACKGROUND

  • 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.

    PMID: 15867014BACKGROUND

  • 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.

    PMID: 11998420BACKGROUND

  • 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.

    PMID: 22291112DERIVED

MeSH Terms

Conditions

Pyelonephritis

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Nephritis, InterstitialNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPyelitisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • CHERON GERARD, MD

    Hôpital Necker Enfants Malades Assistance Publique Hôpitaux de Paris - René Descartes University Paris 5

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 29, 2005

Study Start

July 1, 2005

Primary Completion

June 1, 2008

Study Completion

February 1, 2009

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

FR(12)