Dexamethasone Administration in 1st Episode of Febrile Urinary Tract Infection

NCT02034851 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 183

Last updated 2020-09-16

No results posted yet for this study

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.

Conditions

  • Acute Pyelonephritis

Sponsors & Collaborators

  • Hospital Universitari Sant Joan de Reus

    collaborator OTHER
  • Hospital Universitari Joan XXIII de Tarragona.

    collaborator OTHER
  • Pius Hospital de Valls

    collaborator UNKNOWN
  • Hospital Arnau de Vilanova

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

    collaborator OTHER
  • Maternal-Infantil Vall d´Hebron Hospital

    collaborator OTHER
  • Hospital General Universitario Santa Lucía

    collaborator OTHER
  • University Rovira i Virgili

    collaborator OTHER
  • Institut Investigacio Sanitaria Pere Virgili

    lead OTHER

Principal Investigators

  • Escribano J Joaquin, PhD MD · IISPV- URV-Hospital Universitari Sant Joan de Reus- Research unit in pediatrics, nutrition and human development

  • Closa R Ricardo, MD PhD · IISPV-URV- Hospital Universitari Joan XXIII de Tarragona-Research unit in pediatrics, nutrition and human development

  • Ferré N Natalia, PhD · IISPV-URV-Research unit in pediatrics, nutrition and human development

  • Ibars Z Zaira, MD PhD · HOSPITAL ARNAU DE VILANOVA DE LLEIDA

  • Maria Gloria MG Fraga, MD PhD · HOSPITAL DE LA SANTA CREU I SANT PAU, DE BARCELONA

  • Madrid A Alvaro, MD PhD · HOSPITAL MATERNOINFANTIL VALL D'HBRON, BARCELONA

  • Samper M Manuel, MD PhD · Pius Hospital de Valls

  • Gonzalez JD Juan David, MD PhD · HOSPITAL GENERAL UNIVERSITARIO SANTA LUCÍA DE CARTAGENA

  • Parada E Esther, MD PhD · HOSPITAL JOAN XXII DE TARRAGONA

Eligibility

Min Age
2 Months
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-05-31
Completion
2019-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02034851 on ClinicalTrials.gov