Urinary Tract InfectionPhase 3NCT02331862
To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection
A Phase 3 study testing Methylprednisolone in people with Urinary Tract Infection, run by National Cheng-Kung University Hospital.
Trial summary
Purposes of this study will be as follows: 1. To design a prospective, randomized, and open-labeled study to investigate the effect and the side effect of MPD in combination with conventional antibiotics to affect clinical course, outcome, and medical expenses. 2. Read more about this study
- Who is it for?
- Ages 1 week to 16 years
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- 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 1 week to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1week old ~ 16 years old children with UTI
Who cannot join
- Previous UTI
- Known GU tract obstruction
- Severe sepsis with vital signs change
- Antibiotics used
About this study
Purposes of this study will be as follows:
- To design a prospective, randomized, and open-labeled study to investigate the effect and the side effect of MPD in combination with conventional antibiotics to affect clinical course, outcome, and medical expenses.
- To compare level of the urinary and serum cytokines before and after received MPD for the following sub-aim:
- To determine the population who is benefit from MPD to reduce the severity of clinical course and subsequent renal scarring.
II. To understand the mechanism by which the MPD could shorten the clinical course and reduce the renal scarring.
Read the detailed description
The urinary tract infection (UTI) is a common etiology of the febrile children and the acute pyelonephritis (APN) happen in 70% children with the first febrile UTI. After the first APN, the irreversible renal scarring takes place in about 40% patients. The sequela of the renal scarring includes chronic kidney disease, hypertension, the complication during the pregnancy, and even the end stage of renal diseases. Due to the progression of the pathophysiology of the pyelonephritis and the renal scarring in the past years, we understand that the inflammation is one of the important mechanisms. Therefore, there are many animal studies clarifying the role of the anti-inflammation or antioxidant to reduce the renal scarring. In our previous studies, Dr. Chiou Y.Y. and colleagues has provided the evidence that the adjunctive methylprednisolone (MPD) can decrease the risk of the renal scarring for patients with high risk APN, which was defined as inflammatory volume more than 4.6 mL on technetium-99m-labeled dimercaptosuccinic acid scan or abnormal renal ultrasonography results. Our study is the first human study demonstrating the solution for the renal scarring. However, whether this result can be applied to the whole spectrum of the UTI is still unknown. Purposes of this study will be as follows:
- To design a prospective, randomized, and open-labeled study to investigate the effect and the side effect of MPD in combination with conventional antibiotics to affect clinical course, outcome, and medical expenses.
- To compare level of the urinary and serum cytokines before and after received MPD for the following sub-aim:
- To determine the population who is benefit from MPD to reduce the severity of clinical course and subsequent renal scarring.
II. To understand the mechanism by which the MPD could shorten the clinical course and reduce the renal scarring.
According to these studies, we will provide a new and effective guideline to shorten disease course, save medical expenses, and decrease the risk for renal scarring sequela.
- Conditions
- Urinary Tract Infection
- Being tested
- Methylprednisolone
- Keywords
- urinary tract infection, methylprednisolone
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Adrenal corticosteroid
Add methylprednisolone in addition to the experience antibiotics in children with urinary tract infection to see if the frequency of the renal scar formation could be decreased
| Study group | Role | What they receive |
|---|---|---|
| UTI treated with Methylprednisolone | Experimental | UTI treated with Methylprednisolone in addition to the effective antibiotics Receives: Drug: Methylprednisolone |
| UTI not treated with Methylprednisolone | No intervention | UTI treated with effective antibiotics only |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with renal scar formation
Check the renal scar formation 6.5 months after the UTI
Measured: 6.5 months
Secondary outcomes (2)
Duration of the hospitalization
Check the duration of the hospitalization
Measured: the duration patient in the hospital, may be about 5 days
Expense of the hospitalization
Check the expense of the hospitalization
Measured: the duration patient in the hospital, may be about 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331862
- Sponsor's protocol ID
- B-BR-103-050
- Status last verified
- Jan 2015
- First submitted
- 31 Dec 2014
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT02331862
- Acronym / sponsor ID
- B-BR-103-050
- Conditions
- Urinary Tract Infection
- Keywords
- urinary tract infection, methylprednisolone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 6 Jan 2015 (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.
Purposes of this study will be as follows:
- To design a prospective, randomized, and open-labeled study to investigate the effect and the side effect of MPD in combination with conventional antibiotics to affect clinical course, outcome, and medical expenses.
- To compare level of the urinary and serum cytokines before and after received MPD for the following sub-aim:
- To determine the population who is benefit from MPD to reduce the severity of clinical course and subsequent renal scarring.
II. To understand the mechanism by which the MPD could shorten the clinical course and reduce the renal scarring.
Detailed description
The urinary tract infection (UTI) is a common etiology of the febrile children and the acute pyelonephritis (APN) happen in 70% children with the first febrile UTI. After the first APN, the irreversible renal scarring takes place in about 40% patients. The sequela of the renal scarring includes chronic kidney disease, hypertension, the complication during the pregnancy, and even the end stage of renal diseases. Due to the progression of the pathophysiology of the pyelonephritis and the renal scarring in the past years, we understand that the inflammation is one of the important mechanisms. Therefore, there are many animal studies clarifying the role of the anti-inflammation or antioxidant to reduce the renal scarring. In our previous studies, Dr. Chiou Y.Y. and colleagues has provided the evidence that the adjunctive methylprednisolone (MPD) can decrease the risk of the renal scarring for patients with high risk APN, which was defined as inflammatory volume more than 4.6 mL on technetium-99m-labeled dimercaptosuccinic acid scan or abnormal renal ultrasonography results. Our study is the first human study demonstrating the solution for the renal scarring. However, whether this result can be applied to the whole spectrum of the UTI is still unknown. Purposes of this study will be as follows:
- To design a prospective, randomized, and open-labeled study to investigate the effect and the side effect of MPD in combination with conventional antibiotics to affect clinical course, outcome, and medical expenses.
- To compare level of the urinary and serum cytokines before and after received MPD for the following sub-aim:
- To determine the population who is benefit from MPD to reduce the severity of clinical course and subsequent renal scarring.
II. To understand the mechanism by which the MPD could shorten the clinical course and reduce the renal scarring.
According to these studies, we will provide a new and effective guideline to shorten disease course, save medical expenses, and decrease the risk for renal scarring sequela.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UTI treated with Methylprednisolone | Experimental | Drug: MethylprednisoloneUTI treated with Methylprednisolone in addition to the effective antibiotics |
| UTI not treated with Methylprednisolone | No intervention | –UTI treated with effective antibiotics only |
Who may qualify
- Ages
- 1 week to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1week old ~ 16 years old children with UTI
Key exclusion criteria (4 listed)
- Previous UTI
- Known GU tract obstruction
- Severe sepsis with vital signs change
- Antibiotics used
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 |
|---|---|---|
| MethylprednisoloneAlso: Adrenal corticosteroidAdd methylprednisolone in addition to the experience antibiotics in children with urinary tract infection to see if the frequency of the renal scar formation could be decreased | Drug | UTI treated with Methylprednisolone |
Primary outcome
The proportion of patients with renal scar formation
Time frame: 6.5 months
Check the renal scar formation 6.5 months after the UTI
2 secondary outcomes
Duration of the hospitalization
Time frame: the duration patient in the hospital, may be about 5 days
Expense of the hospitalization
Time frame: the duration patient in the hospital, may be about 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone in people with Urinary Tract Infection, run by National Cheng-Kung University Hospital.
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 1 inclusion and 4 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 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
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?
The proportion of patients with renal scar formation (time frame: 6.5 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 6 Jan 2015.