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

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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.
Information provided by Assistance Publique - Hôpitaux de Paris

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Descriptive Information Fields

Brief Title ^†

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

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.

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 (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.

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

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 Measure ^†

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 ]

Condition ^†

Pyelonephritis

Intervention ^†

Drug: antibiotic
Drug: antibiotics

MEDLINE PMIDs

10772296, 15890693, 15867014, 11998420

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

700

Start Date ^†

July 2005

Completion Date

May 2008

Eligibility 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

Gender

Both

Ages

1 Month to 3 Years

Accepts Healthy Volunteers

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

Location Countries ^†

France

Administrative Information Fields

NCT ID ^†

NCT00136656

Organization ID

P040422

Secondary IDs ^††

AOM 04 105

Study Sponsor ^†

Assistance Publique - Hôpitaux de Paris

Collaborators ^††

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

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

October 2006

First Received Date ^†

August 26, 2005

Last Updated Date

January 16, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.