Dexamethasone Administration in 1st Episode of Febrile Urinary Tract Infection (DEXCAR-0212)

September 15, 2020 updated by: Institut Investigacio Sanitaria Pere Virgili

Phase 3- Dexamethasone Administration in 1st Episode of Febrile Urinary Tract Infection Episode as Renal Damage Prevention Strategy. DEXCAR

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

183

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

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

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 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

  • 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.

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Dexamethasone
Intervention group
Control
Placebo group (physiological saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
renal scarring
Time Frame: 6 month after the acute pyelonephritis episode
6 month after the acute pyelonephritis episode

Collaborators and Investigators

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

Sponsor

Institut Investigacio Sanitaria Pere Virgili

Collaborators

Hospital Arnau de Vilanova
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
University Rovira i Virgili
Hospital General Universitario Santa Lucia
Hospital Universitari Joan XXIII de Tarragona.
Hospital Universitari Sant Joan de Reus
Maternal-Infantil Vall d´Hebron Hospital
Pius Hospital de Valls

Investigators

  • Principal Investigator: 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
  • Study Director: 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

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

April 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IISPV_Pediatria_Dexcar
  • 2011-005805-66 (EudraCT Number)

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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