Dexamethasone Administration in 1st Episode of Febrile Urinary Tract Infection (DEXCAR-0212)
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|ClinicalTrials.gov Identifier: NCT02034851|
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : September 16, 2020
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|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||183 participants|
|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|
Placebo group (physiological saline)
- renal scarring [ Time Frame: 6 month after the acute pyelonephritis episode ]
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
|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|
|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|