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

• ClinicalTrials.gov Identifier: NCT02034851
• Recruitment Status: Completed
• First Posted: January 14, 2014
• Last Update Posted: September 16, 2020
• 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
• Information provided by (Responsible Party): Institut Investigacio Sanitaria Pere Virgili

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
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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• 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

More Information

Additional Information:

• 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
• 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:

Urinary Tract Infections; Pyelonephritis; Infection; Urologic Diseases; Nephritis, Interstitial; Nephritis; Kidney Diseases; Pyelitis