Acute PyelonephritisDEXCAR-0212NCT02034851
Dexamethasone Administration in 1st Episode of Febrile Urinary Tract Infection
An observational study of Acute Pyelonephritis, run by Institut Investigacio Sanitaria Pere Virgili at 7 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 14 years
- Conditions the study is for
- Acute Pyelonephritis
- How many people
- 183 participants
- Where
- 7 sitesSpain
- Study dates
- Apr 2013to Jun 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 14 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Maternoinfantil Vall D'Hebron
Barcelona, E08035
Hospital de La Santa Creu I Sant Pau de Barcelona
Barcelona, E08041
Hospital General Universitario Santa Lucía de Cartagena
Cartagena, Murica, E30202
Hospital Arnau de Vilanova de Lleida
Lleida, E25198
Iispv- Hospital Sant Joan de Reus
Reus, Tarragona, E43204
Iispv-Hospital Joan Xxii de Tarragona
Tarragona, E43007
Pius Hospital de Valls
Valls, Tarragona, E43800
About this study
Official title: Phase 3- Dexamethasone Administration in 1st Episode of Febrile Urinary Tract Infection Episode as Renal Damage Prevention Strategy. DEXCAR
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.
Read the 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.
- Conditions
- Acute Pyelonephritis
- Keywords
- Acute pyelonephritis, Renal scarring, Dexamethasone, Children, Corticoids, Complementary treatment, Prevention strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Intervention group | |
| Control | Placebo group (physiological saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal scarring
Measured: 6 month after the acute pyelonephritis episode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionMay 2016
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PyelonephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Escribano J Joaquin, PhD MD, Principal investigator, IISPV- URV-Hospital Universitari Sant Joan de Reus- Research unit in pediatrics, nutrition and human developmentClosa R Ricardo, MD PhD, Principal investigator, IISPV-URV- Hospital Universitari Joan XXIII de Tarragona-Research unit in pediatrics, nutrition and human developmentFerré N Natalia, PhD, Principal investigator, IISPV-URV-Research unit in pediatrics, nutrition and human developmentIbars Z Zaira, MD PhD, Study director, HOSPITAL ARNAU DE VILANOVA DE LLEIDAMaria Gloria MG Fraga, MD PhD, Study director, HOSPITAL DE LA SANTA CREU I SANT PAU, DE BARCELONAMadrid A Alvaro, MD PhD, Study director, HOSPITAL MATERNOINFANTIL VALL D'HBRON, BARCELONASamper M Manuel, MD PhD, Study director, Pius Hospital de VallsGonzalez JD Juan David, MD PhD, Study director, HOSPITAL GENERAL UNIVERSITARIO SANTA LUCÍA DE CARTAGENA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034851
- Sponsor's protocol ID
- IISPV_Pediatria_Dexcar
- Other IDs
- 2011-005805-66
- Acronym
- DEXCAR-0212
- Status last verified
- Apr 2014
- First submitted
- 10 Jan 2014
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35041042
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3- Dexamethasone Administration in 1st Episode of Febrile Urinary Tract Infection Episode as Renal Damage Prevention Strategy. DEXCAR
- ClinicalTrials.gov ID
- NCT02034851
- Acronym / sponsor ID
- DEXCAR-0212 / IISPV_Pediatria_Dexcar
- Conditions
- Acute Pyelonephritis
- Keywords
- Acute pyelonephritis, Renal scarring, Dexamethasone, Children, Corticoids, Complementary treatment, Prevention strategy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- 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
- Study start
- Apr 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | – | –Intervention group |
| Control | – | –Placebo group (physiological saline) |
Who may qualify
- Ages
- 2 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
renal scarring
Time frame: 6 month after the acute pyelonephritis episode
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 35041042Rius-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Escribano J Joaquin, PhD MD principal investigator
IISPV- URV-Hospital Universitari Sant Joan de Reus- Research unit in pediatrics, nutrition and human development
Closa R Ricardo, MD PhD principal investigator
IISPV-URV- Hospital Universitari Joan XXIII de Tarragona-Research unit in pediatrics, nutrition and human development
Ferré N Natalia, PhD principal investigator
IISPV-URV-Research unit in pediatrics, nutrition and human development
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pyelonephritis, run by Institut Investigacio Sanitaria Pere Virgili at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal scarring (time frame: 6 month after the acute pyelonephritis episode). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02034851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.