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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034851
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : September 16, 2020
Sponsor:
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
Information provided by (Responsible Party):
Institut Investigacio Sanitaria Pere Virgili

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.


Condition or disease
Acute Pyelonephritis

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 183 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Phase 3- Dexamethasone Administration in 1st Episode of Febrile Urinary Tract Infection Episode as Renal Damage Prevention Strategy. DEXCAR
Study Start Date : April 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. renal scarring [ Time Frame: 6 month after the acute pyelonephritis episode ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 14 Years   (Child)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034851


Locations
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Spain
Hospital General Universitario Santa Lucía de Cartagena
Cartagena, Murica, Spain, E30202
Iispv- Hospital Sant Joan de Reus
Reus, Tarragona, Spain, E43204
Pius Hospital de Valls
Valls, Tarragona, Spain, E43800
Hospital Maternoinfantil Vall D'Hebron
Barcelona, Spain, E08035
Hospital de La Santa Creu I Sant Pau de Barcelona
Barcelona, Spain, E08041
Hospital Arnau de Vilanova de Lleida
Lleida, Spain, E25198
Iispv-Hospital Joan Xxii de Tarragona
Tarragona, Spain, E43007
Sponsors and Collaborators
Institut Investigacio Sanitaria Pere Virgili
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
Investigators
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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
Additional Information:

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Responsible Party: Institut Investigacio Sanitaria Pere Virgili
ClinicalTrials.gov Identifier: NCT02034851    
Other Study ID Numbers: IISPV_Pediatria_Dexcar
2011-005805-66 ( EudraCT Number )
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: April 2014
Keywords provided by Institut Investigacio Sanitaria Pere Virgili:
Acute pyelonephritis
Renal scarring
Dexamethasone
Children
Corticoids
Complementary treatment
Prevention strategy
Additional relevant MeSH terms:
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Urinary Tract Infections
Pyelonephritis
Infection
Urologic Diseases
Nephritis, Interstitial
Nephritis
Kidney Diseases
Pyelitis