Urinary Tract Infections in ChildrenPhase 3NCT04654507
Efficacy of Corticosteroids in Reducing Renal Scarring in Acute Pyelonephritis in Children
A Phase 3 study testing Dexamethasone Oral in people with Urinary Tract Infections in Children and Dexamethasone, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Urinary tract infection (UTI) is the most frequently occurring serious bacterial infection in young children and accounts 5 to 14% of emergency department visits Formation of renal scarring in children has been associated with serious complications as hypertension, preeclampsia, and end stage renal failure in young… Read more about this study
- Who is it for?
- Ages 2 months to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections in Children, Dexamethasone, Kidney Scarring
- What is being tested?
- Dexamethasone Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteQatar
- Study dates
- 3 Mar 2021to Dec 2024
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- First episode of acute febrile UTI.
- From 2 months to 14 years of age.
- Fever: ≥ 38.3°C, measured at home or at Pediatric Emergency centers.,
Who cannot join
- Previous history of UTI.
- Urinary tract abnormalities except VUR.
- Antibiotic use within 7 days of enrollment (except last 48 hours)
- previous renal scarring
- patients included in the study and suffered second pyelonephritis during the first 6 months
- Patients allergic to dexamethasone.
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- Endocrinology diseases.
- cancer.
- Planned admission to ICU
- Other bacterial infection as meningitis or pneumonia
- Congenital/acquired immunodeficiency
- Systemic use of corticosteroids or other immunomodulation agents within 14 days of enrollment.
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha, 3050
Mahmoud Alhandi Omar Helal, 50074001, dr.mahmoud.helal@gmail.com
About this study
Official title: Efficacy of Corticosteroids in Reducing Renal Scarring in Acute Pyelonephritis in Children:A Multi-centre, Double-blind, Randomized, Placebo-controlled, Clinical Trial
Urinary tract infection (UTI) is the most frequently occurring serious bacterial infection in young children and accounts 5 to 14% of emergency department visits Formation of renal scarring in children has been associated with serious complications as hypertension, preeclampsia, and end stage renal failure in young age . So, this study aims to determine whether dexamethasone reduces the renal scarring in children will be treated with antibiotics for acute pyelonephritis.
investigators propose to conduct a multi center, randomized, placebo-controlled, double-blind clinical trial, that will evaluate the efficacy of dexamethasone (0.3 mg/kg every 12 hours per day orally for 3 days) in preventing renal scarring in young febrile children (2 months to 14 years) with a first-diagnosed UTI. 120 Participants will be enrolled over a 3-year period from 6 sites.
Read the detailed description
Urinary tract infection (UTI) is the most frequently occurring serious bacterial infection in young children and accounts for 5 to 14% of emergency department visits. UTIs can be divided into asymptomatic bacteriuria, cystitis, and acute pyelonephritis (APN ). The APN is associated with an increased risk of renal damage, acquired through renal scarring. Which is a consequence of the inflammatory and immune response that aim 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 scarring. One of the most relevant factors involved in formation of renal scarring is the production of inflammatory mediators (complement proteins, bactericidal peptides, cytokines , chemokines, ). hence, the use of anti-inflammatory drugs may prevent the release of these mediators and the formation of permanent renal scarring. Renal scarring in childhood has been associated with serious complications as hypertension, preeclampsia, and ESRD in young age.
Current treatment of children with UTI has focused on the treatment of vesicoureteral reflux (VUR) and on the early treatment of UTI with antibiotics. Although the presence of VUR increases the likelihood of bacteria gaining access to the kidney, correction of VUR is not sufficient to prevent scarring. Renal scarring frequently occurs in children who do not have VUR, and early diagnosis and treatment of children with VUR is not associated with a reduction in the incidence of end-stage renal disease. Similarly, early antibiotic therapy is necessary, but it is not sufficient to prevent renal scarring in most children with UTI. Because signs of UTI in children are relatively non-specific, the diagnosis is often delayed. data from many studies have shown that once the infection has localized to the renal parenchyma, treatment with antibiotics alone does not prevent scarring. hence ,It is clear that the current management is not always effective in preventing renal scarring. The proposed study aims to determine whether dexamethasone therapy - which focuses on modulation of the host inflammatory response - is effective in reducing renal scarring.
- Conditions
- Urinary Tract Infections in Children, Dexamethasone, Kidney Scarring, Acute Pyelonephritis, Hypertension in Children, Chronic Renal Failure
- Being tested
- Dexamethasone Oral, Placebo
- Medical subject headings
- Glomerulonephritis, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone OralDrug
Also called corticosteroids
Drug: Dexamethasone 0.3mg/kg/dose twice daily for 3 days
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant dexamethasone | Active comparator | Drug: Dexamethasone Receives: Drug: Dexamethasone Oral |
| Placebo | Placebo comparator | Drug: Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal scarring comparatively with patients those don't take the medicine
Division of Children With Renal Scarring at the Outcome of (DMSA) Renal Scan [ Time Frame: The outcome DMSA scan will be 6 months from enrollment.] Renal scarring is defined as decreased uptake of tracer with or without loss of contours.
Three radiologists independently will review all renal DMSA scans for scarring .
Diagnosis of presence or absence of renal scarring for a kidney , should be endorsed by the majority of readers (2/3).
The child will be determined to have renal scarring if either kidney or both kidneys have scarring by the majority of readers.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start3 Mar 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infections in ChildrenStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alhandi Omar Helal, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654507
- Sponsor's protocol ID
- MRC-01-20-085
- Status last verified
- Jul 2023
- First submitted
- 30 Nov 2020
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Corticosteroids in Reducing Renal Scarring in Acute Pyelonephritis in Children:A Multi-centre, Double-blind, Randomized, Placebo-controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT04654507
- Acronym / sponsor ID
- MRC-01-20-085
- Conditions
- Urinary Tract Infections in Children, Dexamethasone, Kidney Scarring, Acute Pyelonephritis, Hypertension in Children, Chronic Renal Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Dec 2020 (actual)
- 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.
Urinary tract infection (UTI) is the most frequently occurring serious bacterial infection in young children and accounts 5 to 14% of emergency department visits Formation of renal scarring in children has been associated with serious complications as hypertension, preeclampsia, and end stage renal failure in young age . So, this study aims to determine whether dexamethasone reduces the renal scarring in children will be treated with antibiotics for acute pyelonephritis.
investigators propose to conduct a multi center, randomized, placebo-controlled, double-blind clinical trial, that will evaluate the efficacy of dexamethasone (0.3 mg/kg every 12 hours per day orally for 3 days) in preventing renal scarring in young febrile children (2 months to 14 years) with a first-diagnosed UTI. 120 Participants will be enrolled over a 3-year period from 6 sites.
Detailed description
Urinary tract infection (UTI) is the most frequently occurring serious bacterial infection in young children and accounts for 5 to 14% of emergency department visits. UTIs can be divided into asymptomatic bacteriuria, cystitis, and acute pyelonephritis (APN ). The APN is associated with an increased risk of renal damage, acquired through renal scarring. Which is a consequence of the inflammatory and immune response that aim 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 scarring. One of the most relevant factors involved in formation of renal scarring is the production of inflammatory mediators (complement proteins, bactericidal peptides, cytokines , chemokines, ). hence, the use of anti-inflammatory drugs may prevent the release of these mediators and the formation of permanent renal scarring. Renal scarring in childhood has been associated with serious complications as hypertension, preeclampsia, and ESRD in young age.
Current treatment of children with UTI has focused on the treatment of vesicoureteral reflux (VUR) and on the early treatment of UTI with antibiotics. Although the presence of VUR increases the likelihood of bacteria gaining access to the kidney, correction of VUR is not sufficient to prevent scarring. Renal scarring frequently occurs in children who do not have VUR, and early diagnosis and treatment of children with VUR is not associated with a reduction in the incidence of end-stage renal disease. Similarly, early antibiotic therapy is necessary, but it is not sufficient to prevent renal scarring in most children with UTI. Because signs of UTI in children are relatively non-specific, the diagnosis is often delayed. data from many studies have shown that once the infection has localized to the renal parenchyma, treatment with antibiotics alone does not prevent scarring. hence ,It is clear that the current management is not always effective in preventing renal scarring. The proposed study aims to determine whether dexamethasone therapy - which focuses on modulation of the host inflammatory response - is effective in reducing renal scarring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant dexamethasone | Active comparator | Drug: Dexamethasone OralDrug: Dexamethasone |
| Placebo | Placebo comparator | Drug: PlaceboDrug: Placebo |
Who may qualify
- Ages
- 2 months to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- First episode of acute febrile UTI.
- From 2 months to 14 years of age.
- Fever: ≥ 38.3°C, measured at home or at Pediatric Emergency centers.,
Key exclusion criteria (12 listed)
- Previous history of UTI.
- Urinary tract abnormalities except VUR.
- Antibiotic use within 7 days of enrollment (except last 48 hours)
- previous renal scarring
- patients included in the study and suffered second pyelonephritis during the first 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone OralAlso: corticosteroidsDrug: Dexamethasone 0.3mg/kg/dose twice daily for 3 days | Drug | Adjuvant dexamethasone |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Renal scarring comparatively with patients those don't take the medicine
Time frame: 6 months
Division of Children With Renal Scarring at the Outcome of (DMSA) Renal Scan [ Time Frame: The outcome DMSA scan will be 6 months from enrollment.] Renal scarring is defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently will review all renal DMSA scans for scarring . Diagnosis of presence or absence of renal scarring for a kidney , should be endorsed by the majority of readers (2/3). The child will be determined to have renal scarring if either kidney or both kidneys have scarring by the majority of readers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Mahmoud Alhandi Omar Helal principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone Oral in people with Urinary Tract Infections in Children and Dexamethasone, run by Hamad Medical Corporation at 1 site in Qatar.
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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Alhandi Omar Helal (50074001, dr.mahmoud.helal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal scarring comparatively with patients those don't take the medicine (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2023.