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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Netherlands1 site
  • UMC St Radboud

    Nijmegen, Gelderland, 6500

Other trials in Netherlands

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?
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.

  1. Number of antibiotic prescriptions

    Measured: 10 days after 1st contact with GP

  2. Number of referrals

    Measured: 10 days after 1st contact with GP

  3. 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.

  1. First posted19 Apr 2006 (estimated)
  2. Study startMay 2006
  3. Study completionJun 2006

Resources

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)
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 9556646
  • Owen 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 14507794
  • Harmsen, 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 16584577
  • Jacobson 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 2508881
  • Vernon 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 9361538
  • Hansson 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 10229036
  • Harmsen 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 17445745
  • Harmsen 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

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.

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