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

Pyelonephritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136656
• Other study ID #: P040422
• Secondary ID: AOM 04 105
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2005
• Last updated: February 11, 2009
• Start date: July 2005
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: February 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 3 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pyelonephritis

Intervention

Drug:
• antibiotic
cephalosporine by oral route : cefixime
• antibiotics
cephalosporine : ceftriaxone by intra venous route and cefixime by oral route

Locations

Country	Name	City	State
France	Hopital de Bicetre	Bicetre
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	Hôpital Armand Trousseau	Paris
France	Necker Enfants Malades	Paris
France	Robert Debre	Paris
France	Saint Vincent de Paul	Paris
France	Hopital Andre Mignot	Versailles

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

Leroy S, Adamsbaum C, Marc E, Moulin F, Raymond J, Gendrel D, Bréart 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. Epub 2005 May 2. — View Citation

Leroy S, Marc E, Adamsbaum C, Gendrel D, Bréart 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. Epub 2005 May 12. — View Citation

Marc E, Ménager C, Moulin F, Stos B, Chalumeau M, Guérin 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. French. — View Citation

Sannier N, Le Masne A, Sayegh N, Gaillard JL, Chéron G. Ambulatory management of acute pyelonephritis in children. Acta Paediatr. 2000 Mar;89(3):372-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months		between six and eight months	No
Secondary	Time to get apyrexia		4 days	Yes
Secondary	Incidence of urologic abnormalities on cystourethrography done during the first month after the infection		one month	Yes