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

Sponsor

Institut Investigacio Sanitaria Pere Virgili (Other)

Overall Status

Completed

CT.gov ID

NCT02034851

Collaborator

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

183

Enrollment

Locations

Duration (Months)

26.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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:

dexamethasone: 0'30 mg per kg every 12 hours during 3 days.
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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

183 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Dexamethasone Intervention group
Control Placebo group (physiological saline)

Outcome Measures

Primary Outcome Measures

renal scarring [6 month after the acute pyelonephritis episode]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital General Universitario Santa Lucía de Cartagena	Cartagena	Murica	Spain	E30202
2	Iispv- Hospital Sant Joan de Reus	Reus	Tarragona	Spain	E43204
3	Pius Hospital de Valls	Valls	Tarragona	Spain	E43800
4	Hospital Maternoinfantil Vall D'Hebron	Barcelona		Spain	E08035
5	Hospital de La Santa Creu I Sant Pau de Barcelona	Barcelona		Spain	E08041
6	Hospital Arnau de Vilanova de Lleida	Lleida		Spain	E25198
7	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

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