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

February 11, 2009 updated by: Assistance Publique - Hôpitaux de Paris

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

700

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bicetre, France, 94275
        • Hopital de Bicetre
      • Bordeaux, France, 33000
        • Hopital Pellegrin
      • Boulogne, France, 92100
        • Hopital Ambroise Pare
      • Clamart, France, 92141
        • Hopital Antoine Beclere
      • Limoges, France, 87042
        • CHU de Limoges
      • Marseille, France, 13385
        • La Timone
      • Nice, France, 06000
        • CHU Nice
      • Paris, France, 75015
        • Necker Enfants Malades
      • Paris, France, 75571
        • Hôpital Armand Trousseau
      • Paris, France, 75019
        • Robert Debre
      • Paris, France, 75014
        • Saint Vincent de Paul
      • Versailles, France, 78150
        • Hôpital André Mignot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
cefixime antibiotic treatment by oral route
Drug: antibiotic
cephalosporine by oral route : cefixime
Sham Comparator: 2
ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days
Drug: antibiotics
cephalosporine : ceftriaxone by intra venous route and cefixime by oral route

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months
Time Frame: between six and eight months
between six and eight months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to get apyrexia
Time Frame: 4 days
4 days
Incidence of urologic abnormalities on cystourethrography done during the first month after the infection
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

February 12, 2009

Last Update Submitted That Met QC Criteria

February 11, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P040422
  • AOM 04 105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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