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

Tracking Information

First Received Date ^ICMJE

August 26, 2005

Last Updated Date

February 11, 2009

Start Date ^ICMJE

July 2005

Current Primary Outcome Measures ^ICMJE

Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months [ Time Frame: between six and eight months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00136656 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Time to get apyrexia
Incidence of urologic abnormalities on cystourethrography done during the first month after the the infection

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 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.

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. 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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Pyelonephritis

Intervention ^ICMJE

Drug: antibiotic
Drug: antibiotics

Study Arms / Comparison Groups

Active Comparator: cefixime antibiotic treatment by oral route
Sham Comparator: ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

700

Completion Date

February 2009

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Expanded Access Status

Administrative Information

NCT ID ^ICMJE

NCT00136656

Responsible Party

Thérèse NGOUE, Department Clinical Research of Developpement

Secondary IDs ^ICMJE

AOM 04 105

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Investigators ^ICMJE

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

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP