NCT02034851

Brief Summary

Hypothesis: Administration of corticoids (dexamethasone) together with the conventional antibiotherapy in the acute phase of a febrile urinary tract infection could reduce the risk of renal scarring after 6 months of the primo-infection. Primary objectives:To evaluate the reduction in incidence of renal scarring after 6 months of a acute pyelonephritis between the control group (conventional therapy plus placebo) and intervention group (conventional therapy plus dexamethasone. Design: Multicentre randomized clinical trial,placebo controled, including children between 2 months and 14 years with a acute pyelonephritis proven by a acute phase DMSA (dimethylsuccinic acid ). A total of 180 children in to parallel groups (intervention and placebo) will be included.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 16, 2020

Status Verified

April 1, 2014

Enrollment Period

3.1 years

First QC Date

January 10, 2014

Last Update Submit

September 15, 2020

Conditions

Acute Pyelonephritis

Keywords

Acute pyelonephritisRenal scarringDexamethasoneChildrenCorticoidsComplementary treatmentPrevention strategy

Outcome Measures

Primary Outcomes (1)

  • renal scarring

    6 month after the acute pyelonephritis episode

Study Arms (2)

Dexamethasone

Intervention group

Control

Placebo group (physiological saline)

Eligibility Criteria

Age2 Months - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Those children between 2 months and 14 years with a provable acute pyelonephritis that fulfill the hospitalization criteria defined in the Spanish Clinical practice guide.

You may qualify if:

  • Those children between 2 months and 14 years with a provable acute pyelonephritis that fulfill the hospitalization criteria defined in the Spanish Clinical practice guide. Briefly:
  • age under 3 months.
  • general affectation, toxic appearance.
  • vomiting or oral intolerance.
  • dehydration, bad peripheric perfusion.
  • or other intermedia situations that include:
  • high fever (\>38.5 Celsius) in 3-6 month old children.
  • unusual germ risk factors.
  • family history of vesicoureteral reflux.
  • recurrent febrile urinary infections. With absence of a previous renal scarring objectivated after a DMSA.
  • high elevation of acute phase reactants.

You may not qualify if:

  • those eligible patients that do not fulfill the hospitalization criteria.
  • patients with a procalcitonin under 0.05 ng per ml.
  • patients with previous uropathy or renal scarring
  • patients allergic to dexamethasone.
  • endocrinologic disease.
  • history of cancer.
  • serious illness.
  • immunosuppressor treatment.
  • previous treatment with corticoids (continuous oral or parenteral treatment) during the last 2 months.
  • the patient included in the study that do not present pyelonephritis after the acute phase DMSA evaluation will be excluded.
  • the patient included in the study that suffered a second pyelonephritis episode during the following 6 months (before the second DMSA evaluation) will be excluded for the primary output analyses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital General Universitario Santa Lucía de Cartagena

Cartagena, Murica, E30202, Spain

Location

Iispv- Hospital Sant Joan de Reus

Reus, Tarragona, E43204, Spain

Location

Pius Hospital de Valls

Valls, Tarragona, E43800, Spain

Location

Hospital Maternoinfantil Vall D'Hebron

Barcelona, E08035, Spain

Location

Hospital de La Santa Creu I Sant Pau de Barcelona

Barcelona, E08041, Spain

Location

Hospital Arnau de Vilanova de Lleida

Lleida, E25198, Spain

Location

Iispv-Hospital Joan Xxii de Tarragona

Tarragona, E43007, Spain

Location

Related Publications (1)

  • Rius-Gordillo N, Ferre N, Gonzalez JD, Ibars Z, Parada-Ricart E, Fraga MG, Chocron S, Samper M, Vicente C, Fuertes J, Escribano J; DEXCAR Study Group. Dexamethasone to prevent kidney scarring in acute pyelonephritis: a randomized clinical trial. Pediatr Nephrol. 2022 Sep;37(9):2109-2118. doi: 10.1007/s00467-021-05398-w. Epub 2022 Jan 18.

    PMID: 35041042DERIVED

Study Officials

  • Escribano J Joaquin, PhD MD

    IISPV- URV-Hospital Universitari Sant Joan de Reus- Research unit in pediatrics, nutrition and human development

    PRINCIPAL INVESTIGATOR

  • Closa R Ricardo, MD PhD

    IISPV-URV- Hospital Universitari Joan XXIII de Tarragona-Research unit in pediatrics, nutrition and human development

    PRINCIPAL INVESTIGATOR

  • Ferré N Natalia, PhD

    IISPV-URV-Research unit in pediatrics, nutrition and human development

    PRINCIPAL INVESTIGATOR

  • Ibars Z Zaira, MD PhD

    HOSPITAL ARNAU DE VILANOVA DE LLEIDA

    STUDY DIRECTOR

  • Maria Gloria MG Fraga, MD PhD

    HOSPITAL DE LA SANTA CREU I SANT PAU, DE BARCELONA

    STUDY DIRECTOR

  • Madrid A Alvaro, MD PhD

    HOSPITAL MATERNOINFANTIL VALL D'HBRON, BARCELONA

    STUDY DIRECTOR

  • Samper M Manuel, MD PhD

    Pius Hospital de Valls

    STUDY DIRECTOR

  • Gonzalez JD Juan David, MD PhD

    HOSPITAL GENERAL UNIVERSITARIO SANTA LUCÍA DE CARTAGENA

    STUDY DIRECTOR

  • Parada E Esther, MD PhD

    HOSPITAL JOAN XXII DE TARRAGONA

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 14, 2014

Study Start

April 1, 2013

Primary Completion

May 1, 2016

Study Completion

June 1, 2019

Last Updated

September 16, 2020

Record last verified: 2014-04

Locations

ES(7)