Urinary Tract InfectionsNCT00316043
Prevention of Renal Failure in Children With Urinary Tract Infections
A study testing Written information for parents, Distance learning package for General Practitioners and Distance learning package for practice assistants in people with Urinary Tract Infections, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The aim of the study is to describe the current clinical management of young children with urinary tract infections in Dutch primary care and also to describe the possibilities for improvement and potential cost-efficiency of improved care in the light of preventing renal failure. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Written information for parents, Distance learning package for General Practitioners and Distance learning package for practice assistants
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 124 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2006to Jun 2006
- Phase
- Interventional
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children between 0-12 years of age with a proven urinary tract infection in general practice
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Renal Failure in Children With Urinary Tract Infections in General Practice: Current Clinical Management, Possibilities for Improvement and Potential Cost-Efficiency
The aim of the study is to describe the current clinical management of young children with urinary tract infections in Dutch primary care and also to describe the possibilities for improvement and potential cost-efficiency of improved care in the light of preventing renal failure.
Read the detailed description
The aim of the study is to describe the current clinical management of young children with urinary tract infections in Dutch primary care and also to describe the possibilities for improvement and potential cost-efficiency of improved care in the light of preventing renal failure.
The 4 phases of the study contain the following questions:
- Phase 1: What is the current clinical management of urinary tract infections in young children in primary care?
- Phase 2: What are the possibilities for improving the clinical management of urinary tract infections and are these improvements practically achievable?
- Phase 3: What is the cost-efficiency of the several interventions for improving clinical management of urinary tract infections
- Phase 4: What is the influence of the intervention on clinical management?
- Conditions
- Urinary Tract Infections
- Being tested
- Written information for parents, Distance learning package for General Practitioners, Distance learning package for practice assistants
- Keywords
- Urinary tract infections, Renal failure, Renal scarring, Prevention, Primary Care, General Practice, Intervention Studies, Children
- Medical subject headings
- Urinary Tract Infections, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written information for parentsBehavioural
Distance learning package for General PractitionersBehavioural
Distance learning package for practice assistantsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of antibiotic prescriptions
Measured: 10 days after 1st contact with GP
Number of referrals
Measured: 10 days after 1st contact with GP
Number of follow-up appointments
Measured: 10 days after 1st contact with GP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study startMay 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Investigators
- Michel Wensing, dr., Principal investigator, UMC St Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316043
- Sponsor's protocol ID
- WOK_PNKU_01
- Other IDs
- OV02 (Dutch Kidney Foundation)
- Status last verified
- Jul 2007
- First submitted
- 14 Apr 2006
- Last updated
- 31 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Ahmed SM, Swedlund SK. Evaluation and treatment of urinary tract infections in children. Am Fam Physician. 1998 Apr 1;57(7):1573-80, 1583-4.
PubMed 9556646Owen D, Vidal-Alaball J, Mansour M, Bordeaux K, Jones KV, Edwards A. Parent's opinions on the diagnosis of children under 2 years of age with urinary tract infection. Fam Pract. 2003 Oct;20(5):531-7. doi: 10.1093/fampra/cmg507.
PubMed 14507794Harmsen, M et al. Urinary tract infections in young children: high guideline adherence of triage nurses at general practice co-operatives. Quality in Primary Care, 13: 241-7, 2005
Kwok WY, de Kwaadsteniet MC, Harmsen M, van Suijlekom-Smit LW, Schellevis FG, van der Wouden JC. Incidence rates and management of urinary tract infections among children in Dutch general practice: results from a nation-wide registration study. BMC Pediatr. 2006 Apr 4;6:10. doi: 10.1186/1471-2431-6-10.
PubMed 16584577Jacobson SH, Eklof O, Eriksson CG, Lins LE, Tidgren B, Winberg J. Development of hypertension and uraemia after pyelonephritis in childhood: 27 year follow up. BMJ. 1989 Sep 16;299(6701):703-6. doi: 10.1136/bmj.299.6701.703.
PubMed 2508881Vernon SJ, Coulthard MG, Lambert HJ, Keir MJ, Matthews JN. New renal scarring in children who at age 3 and 4 years had had normal scans with dimercaptosuccinic acid: follow up study. BMJ. 1997 Oct 11;315(7113):905-8. doi: 10.1136/bmj.315.7113.905.
PubMed 9361538Hansson S, Bollgren I, Esbjorner E, Jakobsson B, Marild S. Urinary tract infections in children below two years of age: a quality assurance project in Sweden. The Swedish Pediatric Nephrology Association. Acta Paediatr. 1999 Mar;88(3):270-4. doi: 10.1080/08035259950170015.
PubMed 10229036Harmsen M, Wensing M, van der Wouden JC, Grol RP. Parents' awareness of and knowledge about young children's urinary tract infections. Patient Educ Couns. 2007 May;66(2):250-5. doi: 10.1016/j.pec.2006.12.009.
PubMed 17445745Harmsen M, Wensing M, Braspenning JC, Wolters RJ, van der Wouden JC, Grol RP. Management of children's urinary tract infections in Dutch family practice: a cohort study. BMC Fam Pract. 2007 Mar 13;8:9. doi: 10.1186/1471-2296-8-9.
PubMed 17355617
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Renal Failure in Children With Urinary Tract Infections in General Practice: Current Clinical Management, Possibilities for Improvement and Potential Cost-Efficiency
- ClinicalTrials.gov ID
- NCT00316043
- Acronym / sponsor ID
- WOK_PNKU_01
- Conditions
- Urinary Tract Infections
- Keywords
- Urinary tract infections, Renal failure, Renal scarring, Prevention, Primary Care, General Practice, Intervention Studies, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Study start
- May 2006
- Study completion
- Jun 2006 (actual)
- First posted
- 19 Apr 2006 (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 aim of the study is to describe the current clinical management of young children with urinary tract infections in Dutch primary care and also to describe the possibilities for improvement and potential cost-efficiency of improved care in the light of preventing renal failure.
Detailed description
The aim of the study is to describe the current clinical management of young children with urinary tract infections in Dutch primary care and also to describe the possibilities for improvement and potential cost-efficiency of improved care in the light of preventing renal failure.
The 4 phases of the study contain the following questions:
- Phase 1: What is the current clinical management of urinary tract infections in young children in primary care?
- Phase 2: What are the possibilities for improving the clinical management of urinary tract infections and are these improvements practically achievable?
- Phase 3: What is the cost-efficiency of the several interventions for improving clinical management of urinary tract infections
- Phase 4: What is the influence of the intervention on clinical management?
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children between 0-12 years of age with a proven urinary tract infection in general practice
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Written information for parents | Behavioural | – |
| Distance learning package for General Practitioners | Behavioural | – |
| Distance learning package for practice assistants | Behavioural | – |
Primary outcome
Number of antibiotic prescriptions
Time frame: 10 days after 1st contact with GP
Number of referrals
Time frame: 10 days after 1st contact with GP
Number of follow-up appointments
Time frame: 10 days after 1st contact with GP
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 31 Jul 2007.
- Background: PubMed 9556646Ahmed SM, Swedlund SK. Evaluation and treatment of urinary tract infections in children. Am Fam Physician. 1998 Apr 1;57(7):1573-80, 1583-4.
- Background: PubMed 14507794Owen D, Vidal-Alaball J, Mansour M, Bordeaux K, Jones KV, Edwards A. Parent's opinions on the diagnosis of children under 2 years of age with urinary tract infection. Fam Pract. 2003 Oct;20(5):531-7. doi: 10.1093/fampra/cmg507.
- BackgroundHarmsen, M et al. Urinary tract infections in young children: high guideline adherence of triage nurses at general practice co-operatives. Quality in Primary Care, 13: 241-7, 2005
- Background: PubMed 16584577Kwok WY, de Kwaadsteniet MC, Harmsen M, van Suijlekom-Smit LW, Schellevis FG, van der Wouden JC. Incidence rates and management of urinary tract infections among children in Dutch general practice: results from a nation-wide registration study. BMC Pediatr. 2006 Apr 4;6:10. doi: 10.1186/1471-2431-6-10.
- Background: PubMed 2508881Jacobson SH, Eklof O, Eriksson CG, Lins LE, Tidgren B, Winberg J. Development of hypertension and uraemia after pyelonephritis in childhood: 27 year follow up. BMJ. 1989 Sep 16;299(6701):703-6. doi: 10.1136/bmj.299.6701.703.
- Background: PubMed 9361538Vernon SJ, Coulthard MG, Lambert HJ, Keir MJ, Matthews JN. New renal scarring in children who at age 3 and 4 years had had normal scans with dimercaptosuccinic acid: follow up study. BMJ. 1997 Oct 11;315(7113):905-8. doi: 10.1136/bmj.315.7113.905.
- Background: PubMed 10229036Hansson S, Bollgren I, Esbjorner E, Jakobsson B, Marild S. Urinary tract infections in children below two years of age: a quality assurance project in Sweden. The Swedish Pediatric Nephrology Association. Acta Paediatr. 1999 Mar;88(3):270-4. doi: 10.1080/08035259950170015.
- Background: PubMed 17445745Harmsen M, Wensing M, van der Wouden JC, Grol RP. Parents' awareness of and knowledge about young children's urinary tract infections. Patient Educ Couns. 2007 May;66(2):250-5. doi: 10.1016/j.pec.2006.12.009.
- Background: PubMed 17355617Harmsen M, Wensing M, Braspenning JC, Wolters RJ, van der Wouden JC, Grol RP. Management of children's urinary tract infections in Dutch family practice: a cohort study. BMC Fam Pract. 2007 Mar 13;8:9. doi: 10.1186/1471-2296-8-9.
- Related InfoLink provided by the sponsor.
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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.
Michel Wensing, dr. principal investigator
UMC St Radboud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written information for parents, Distance learning package for General Practitioners and Distance learning package for practice assistants in people with Urinary Tract Infections, run by Radboud University Medical Center at 1 site in Netherlands.
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 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: finished, as of the sponsor's last update on 31 Jul 2007. 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 Netherlands. 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?
Number of antibiotic prescriptions (time frame: 10 days after 1st contact with GP). The study lists 3 primary outcomes in all. 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 NCT00316043, which also lists 9 linked publications.
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 31 Jul 2007.