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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00316043
Other study ID # WOK_PNKU_01
Secondary ID OV02 (Dutch Kidn
Status Completed
Phase N/A
First received April 14, 2006
Last updated July 30, 2007
Start date May 2006
Est. completion date June 2006

Study information

Verified date July 2007
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical 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.


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?


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 12 Years
Eligibility Inclusion Criteria:

- children between 0-12 years of age with a proven urinary tract infection in general practice

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label


Intervention

Behavioral:
Written information for parents

Distance learning package for General Practitioners

Distance learning package for practice assistants


Locations

Country Name City State
Netherlands UMC St Radboud Nijmegen Gelderland

Sponsors (2)

Lead Sponsor Collaborator
Radboud University Dutch Kidney Foundation

Country where clinical trial is conducted

Netherlands, 

References & Publications (9)

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. Review. — View Citation

Hansson S, Bollgren I, Esbjörner E, Jakobsson B, Mårild 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. — View Citation

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. — View Citation

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. — View Citation

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

Jacobson SH, Eklöf 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of antibiotic prescriptions 10 days after 1st contact with GP
Primary Number of referrals 10 days after 1st contact with GP
Primary Number of follow-up appointments 10 days after 1st contact with GP
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