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CompletedNCT02034851DEXCAR-0212Updated Sep 16, 2020

Dexamethasone Administration in 1st Episode of Febrile Urinary Tract Infection

An observational study in Acute Pyelonephritis, sponsored by Institut Investigacio Sanitaria Pere Virgili. Completed at 7 sites in Spain. Open to participants aged 2 Months to 14 Years. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Institut Investigacio Sanitaria Pere Virgili · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
183
Ages
2 Months to 14 Years
Sex
All
01

Study 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.

Read the detailed description

The urinary tract infection (UTI) is one of the most common bacterial infections in children. These infections can be grouped clinically as asymptomatic bacteriuria , cystitis (lower urinary tract infection ) and acute pyelonephritis (APN ) when the infection reaches the upper urinary tract. This classification is of great clinical relevance because while cystitis is usually a benign condition without further complications , the APN is associated with an increased risk of kidney damage, acquired through renal scarring . Renal scarring is a consequence of the inflammatory and immune response that is triggered to eradicate the bacteria involved in the UTI. Parenchymal infection can be solved , but there are a number of poorly understood factors that may perpetuate inflammation and this would promote the formation of scar nephritis. One of the most relevant factors involved in the renal scarring development are the production of inflammatory mediators (complement proteins, bactericidal peptides, cytokines such as IL6 and IL8, chemokines, and adhesion molecules defensins). Thus, it is obvious to think that the use of anti-inflammatory drugs may prevent the release of these mediators and the development of permanent kidney damage.

Intervention: the two parallel groups will receive the conventional therapy plus:

  1. dexamethasone: 0'30 mg per kg every 12 hours during 3 days.
  2. placebo (physiological saline)at the same dosing regimen.

Centralized lecture of the late DMSA after 6 months of the pyelonephritis episode will be performed. Renal scarring presence and grade will be reported.

02

Conditions studied

  • Acute Pyelonephritis

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Keywords

  • Acute pyelonephritis
  • Renal scarring
  • Dexamethasone
  • Children
  • Corticoids
  • Complementary treatment
  • Prevention strategy
03

In context

Pyelonephritis

79 studies on the registry are indexed under Pyelonephritis; 12 are open to participants now.

This study's enrollment of 183 is above the median of 153 across 15 observational studies indexed under Pyelonephritis.

Browse Pyelonephritis studies →

Lead sponsor

Institut Investigacio Sanitaria Pere Virgili is the lead sponsor of 39 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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:

    1. high fever (>38.5 Celsius) in 3-6 month old children.
    2. unusual germ risk factors.
    3. family history of vesicoureteral reflux.
    4. recurrent febrile urinary infections. With absence of a previous renal scarring objectivated after a DMSA.
    5. high elevation of acute phase reactants.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
183 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Dexamethasone

    Intervention group

  • Control

    Placebo group (physiological saline)

06

What researchers measure

Primary outcomes

  1. renal scarring

    Time frame: 6 month after the acute pyelonephritis episode

07

Study locations

7 sites
  • Hospital General Universitario Santa Lucía de Cartagena
    Cartagena, Murica E30202, Spain
  • Iispv- Hospital Sant Joan de Reus
    Reus, Tarragona E43204, Spain
  • Pius Hospital de Valls
    Valls, Tarragona E43800, Spain
  • Hospital Maternoinfantil Vall D'Hebron
    Barcelona, E08035, Spain
  • Hospital de La Santa Creu I Sant Pau de Barcelona
    Barcelona, E08041, Spain
  • Hospital Arnau de Vilanova de Lleida
    Lleida, E25198, Spain
  • Iispv-Hospital Joan Xxii de Tarragona
    Tarragona, E43007, Spain
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References and documents

Publications

  • 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. PubMed 35041042 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02034851
Lead sponsor
Institut Investigacio Sanitaria Pere Virgili
Collaborators
Hospital Universitari Sant Joan de Reus, Hospital Universitari Joan XXIII de Tarragona., Pius Hospital de Valls, Hospital Arnau de Vilanova, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Maternal-Infantil Vall d´Hebron Hospital, Hospital General Universitario Santa Lucía, University Rovira i Virgili
Responsible party
Sponsor
First posted
Jan 14, 2014
Start date
Apr 2013
Primary completion
May 2016
Completion
Jun 2019
Last update
Sep 16, 2020

Study contacts

Escribano J Joaquin, PhD MD
principal investigator · IISPV- URV-Hospital Universitari Sant Joan de Reus- Research unit in pediatrics, nutrition and human development
Closa R Ricardo, MD PhD
principal investigator · IISPV-URV- Hospital Universitari Joan XXIII de Tarragona-Research unit in pediatrics, nutrition and human development
Ferré N Natalia, PhD
principal investigator · IISPV-URV-Research unit in pediatrics, nutrition and human development
Ibars Z Zaira, MD PhD
study director · HOSPITAL ARNAU DE VILANOVA DE LLEIDA
Maria Gloria MG Fraga, MD PhD
study director · HOSPITAL DE LA SANTA CREU I SANT PAU, DE BARCELONA
Madrid A Alvaro, MD PhD
study director · HOSPITAL MATERNOINFANTIL VALL D'HBRON, BARCELONA
Samper M Manuel, MD PhD
study director · Pius Hospital de Valls
Gonzalez JD Juan David, MD PhD
study director · HOSPITAL GENERAL UNIVERSITARIO SANTA LUCÍA DE CARTAGENA
Parada E Esther, MD PhD
study director · HOSPITAL JOAN XXII DE TARRAGONA

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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