Kidney Scarring Post-Febrile UTINCT00868270
Urinary Cytokine Levels as a Prognostic Marker for Kidney Scarring After Pyelonephritis
An observational study of Kidney Scarring Post-Febrile UTI, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The prevalence of kidney scarring after UTI is approximately 5-57%. UTIs are caused mainly by bacteria that cause local and systemic immunological reaction that are accompanied by cytokines. These cytokines are a main factor in the inflammatory process. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Kidney Scarring Post-Febrile UTI
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- May 2009to not given
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Hospitalized children with UTIs
Who may be able to join
- Children aged 0-7
- First episode febrile UTI
Who cannot join
- Recurrent UTI
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of kidney scarring after UTI is approximately 5-57%. UTIs are caused mainly by bacteria that cause local and systemic immunological reaction that are accompanied by cytokines. These cytokines are a main factor in the inflammatory process. They are produced by leukocytes, macrophages, fibroblasts, endothelial cells and epithelial cells in the kidney tissue. Interleukin 6 and 8 (IL-6 IL-8) were found in high levels in the urine of children and adults who suffer from UTIs. Other studies on animals have found a relationship between inflammatory reaction and scarring in the kidney. We hypothesize that we will find a similar relationship between the level of IL-6, IL-8 in the urine during acute pyelonephritis in children and the probability of kidney scarring.
- Conditions
- Kidney Scarring Post-Febrile UTI
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 |
|---|---|---|
| Children with UTIs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
High prevalence of kidney scarring in children with high levels of urine interleukins
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Scarring Post-Febrile UTIStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868270
- Sponsor's protocol ID
- HY55-08
- Status last verified
- Mar 2009
- First submitted
- 22 Mar 2009
- Last updated
- 24 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Cytokine Levels as a Prognostic Marker for Kidney Scarring After Pyelonephritis
- ClinicalTrials.gov ID
- NCT00868270
- Acronym / sponsor ID
- HY55-08
- Conditions
- Kidney Scarring Post-Febrile UTI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- May 2009
- First posted
- 24 Mar 2009 (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.
The prevalence of kidney scarring after UTI is approximately 5-57%. UTIs are caused mainly by bacteria that cause local and systemic immunological reaction that are accompanied by cytokines. These cytokines are a main factor in the inflammatory process. They are produced by leukocytes, macrophages, fibroblasts, endothelial cells and epithelial cells in the kidney tissue. Interleukin 6 and 8 (IL-6 IL-8) were found in high levels in the urine of children and adults who suffer from UTIs. Other studies on animals have found a relationship between inflammatory reaction and scarring in the kidney. We hypothesize that we will find a similar relationship between the level of IL-6, IL-8 in the urine during acute pyelonephritis in children and the probability of kidney scarring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with UTIs | – | – |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hospitalized children with UTIs
Key inclusion criteria (2 listed)
- Children aged 0-7
- First episode febrile UTI
Key exclusion criteria (1 listed)
- Recurrent UTI
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
High prevalence of kidney scarring in children with high levels of urine interleukins
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2009.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Scarring Post-Febrile UTI, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 2 inclusion and 1 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 24 Mar 2009. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan Jassar, MD (972-4-630-4332, hasjassar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High prevalence of kidney scarring in children with high levels of urine interleukins (time frame: six 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 24 Mar 2009.