Dexamethasone Administration in 1st Episode of Febrile Urinary Tract Infection

NCT ID: NCT02034851

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 183 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2019-06-30

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.

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.

Conditions

Acute Pyelonephritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Dexamethasone

Intervention group

No interventions assigned to this group

Control

Placebo group (physiological saline)

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Sant Joan de Reus

OTHER

Sponsor Role: collaborator

Hospital Universitari Joan XXIII de Tarragona.

OTHER

Sponsor Role: collaborator

Pius Hospital de Valls

UNKNOWN

Sponsor Role: collaborator

Hospital Arnau de Vilanova

OTHER

Sponsor Role: collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: collaborator

Maternal-Infantil Vall d´Hebron Hospital

OTHER

Sponsor Role: collaborator

Hospital General Universitario Santa Lucía

OTHER

Sponsor Role: collaborator

University Rovira i Virgili

OTHER

Sponsor Role: collaborator

Institut Investigacio Sanitaria Pere Virgili

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Escribano J Joaquin, PhD MD

Role: PRINCIPAL_INVESTIGATOR

IISPV- URV-Hospital Universitari Sant Joan de Reus- Research unit in pediatrics, nutrition and human development

Closa R Ricardo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

IISPV-URV- Hospital Universitari Joan XXIII de Tarragona-Research unit in pediatrics, nutrition and human development

Ferré N Natalia, PhD

Role: PRINCIPAL_INVESTIGATOR

IISPV-URV-Research unit in pediatrics, nutrition and human development

Ibars Z Zaira, MD PhD

Role: STUDY_DIRECTOR

HOSPITAL ARNAU DE VILANOVA DE LLEIDA

Maria Gloria MG Fraga, MD PhD

Role: STUDY_DIRECTOR

HOSPITAL DE LA SANTA CREU I SANT PAU, DE BARCELONA

Madrid A Alvaro, MD PhD

Role: STUDY_DIRECTOR

HOSPITAL MATERNOINFANTIL VALL D'HBRON, BARCELONA

Samper M Manuel, MD PhD

Role: STUDY_DIRECTOR

Pius Hospital de Valls

Gonzalez JD Juan David, MD PhD

Role: STUDY_DIRECTOR

HOSPITAL GENERAL UNIVERSITARIO SANTA LUCÍA DE CARTAGENA

Parada E Esther, MD PhD

Role: STUDY_DIRECTOR

HOSPITAL JOAN XXII DE TARRAGONA

Locations

Hospital General Universitario Santa Lucía de Cartagena

Cartagena, Murica, Spain

Iispv- Hospital Sant Joan de Reus

Reus, Tarragona, Spain

Pius Hospital de Valls

Valls, Tarragona, Spain

Hospital Maternoinfantil Vall D'Hebron

Barcelona, , Spain

Hospital de La Santa Creu I Sant Pau de Barcelona

Barcelona, , Spain

Hospital Arnau de Vilanova de Lleida

Lleida, , Spain

Iispv-Hospital Joan Xxii de Tarragona

Tarragona, , Spain

Countries

Spain

References

Rius-Gordillo N, Ferre N, Gonzalez JD, Ibars Z, Parada-Ricart E, Fraga MG, Chocron S, Samper M, Vicente C, Fuertes J, Escribano J; DEXCAR Study Group. Dexamethasone to prevent kidney scarring in acute pyelonephritis: a randomized clinical trial. Pediatr Nephrol. 2022 Sep;37(9):2109-2118. doi: 10.1007/s00467-021-05398-w. Epub 2022 Jan 18.

Reference Type: DERIVED

PMID: 35041042 (View on PubMed)

Other Identifiers

2011-005805-66

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IISPV_Pediatria_Dexcar

Identifier Type: -

Identifier Source: org_study_id