Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old
NCT ID: NCT00136656
Last Updated: 2009-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
700 participants
INTERVENTIONAL
2005-07-31
2009-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
cefixime antibiotic treatment by oral route
antibiotic
cephalosporine by oral route : cefixime
2
ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days
antibiotics
cephalosporine : ceftriaxone by intra venous route and cefixime by oral route
Interventions
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antibiotic
cephalosporine by oral route : cefixime
antibiotics
cephalosporine : ceftriaxone by intra venous route and cefixime by oral route
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Month
3 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Department Clinical Research of Developpement
Principal Investigators
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CHERON GERARD, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Necker Enfants Malades Assistance Publique Hôpitaux de Paris - René Descartes University Paris 5
CHEVALLIER BERTRAND, MD
Role: STUDY_CHAIR
Ambroise Paré Hospital, Assistance Publique Hôpitaux de Paris
GAJDOS VINCENT, MD
Role: STUDY_CHAIR
Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris
LABRUNE PHILIPPE, MD
Role: STUDY_CHAIR
Antoine Béclère Hospital Assistance Publique Hôpitaux de Paris
GRIMPREL EMMANUEL, MD
Role: STUDY_CHAIR
Trousseau Hospital AP HP
DESCHENES GEORGES, MD
Role: STUDY_CHAIR
TROUSSEAU HOSPITAL AP-HP
SERGENT ALINE, MD
Role: STUDY_CHAIR
TROUSSEAU HOSPITAL AP-HP
VAYLET CLAIRE, MD
Role: STUDY_CHAIR
TROUSSEAU HOSPITAL AP-HP
BADER MEUNIER BRIGITTE, MD
Role: STUDY_CHAIR
BICETRE HOSPITAL AP-HP
GUIGONIS VINCENT, MD
Role: STUDY_CHAIR
DUPUYTREN HOSPITAL CHU LIMOGES
Locations
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Hopital de Bicetre
Bicêtre, , France
Hopital Pellegrin
Bordeaux, , France
Hôpital Ambroise Pare
Boulogne, , France
Hôpital Antoine Beclere
Clamart, , France
Chu de Limoges
Limoges, , France
La Timone
Marseille, , France
CHU NICE
Nice, , France
Saint Vincent de Paul
Paris, , France
Necker Enfants Malades
Paris, , France
Robert Debre
Paris, , France
Hôpital Armand Trousseau
Paris, , France
Hopital Andre Mignot
Versailles, , France
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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AOM 04 105
Identifier Type: -
Identifier Source: secondary_id
P040422
Identifier Type: -
Identifier Source: org_study_id
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