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Antibiotic Prophylaxis in Children With Pyelonephritis

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ClinicalTrials.gov Identifier: NCT00752375
Recruitment Status : Withdrawn (No participants)
First Posted : September 15, 2008
Last Update Posted : January 16, 2015
Sponsor:
Collaborator:
Canadian Urological Association
Information provided by (Responsible Party):
Darcie Kiddoo, University of Alberta

Tracking Information
First Submitted Date  ICMJE September 11, 2008
First Posted Date  ICMJE September 15, 2008
Last Update Posted Date January 16, 2015
Study Start Date  ICMJE February 2009
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2008)
To determine whether antibiotic prophylaxis prevents recurrent urinary tract infections by assessing if there is a decreased incidence of urinary tract infections. [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00752375 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2008)
  • To determine whether antibiotic prophylaxis prevents long-term renal scarring by assessing results of DMSA scans to look at long term renal scarring. [ Time Frame: One year and five years ]
  • To determine whether recurrent infections and involvement with the medical system impacts quality of life by assessing how this medical condition affects children using standardized quality of life questionnaires. [ Time Frame: Yearly for five years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotic Prophylaxis in Children With Pyelonephritis
Official Title  ICMJE A Randomized Controlled Trial of Antibiotic Prophylaxis in Children With Pyelonephritis in the Abscence of Vesicoureteral Reflux
Brief Summary Children who present with pyelonephritis undergo many investigations, and long term care to prevent renal damage. The focus is primarily on preventing renal failure however along the way and particularly with children, other issues arise which impact their lives, as well as their family's lives. Parents are concerned about subjecting their children to invasive procedures and long term antibiotic use, particularly if they are not sure of the benefit. This study seeks to provide information on the impact of investigation and long term antibiotic treatment in reference to long term health and quality of life in children who present with febrile urinary tract infections in the absence of anatomic abnormalities.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pyelonephritis
Intervention  ICMJE
  • Drug: Trimethoprim Sulfamethoxazole
    • Children >3months of age will receive Trimethoprim Sulfamethoxazole (2mg/kg Trimethoprim component)per day for one year.
    • Children under 3 months of age will receive amoxicillin 10mg/kg once per day for one year.
    • Those children with a Sulfa allergy will receive nitrofurantoin (1mg/kg) once per day for one year.
    Other Names:
    • Septa
    • Bactrim
  • Drug: placebo
    • Placebo matching Trimethoprim Sulfamethoxazole (2mg/kg Trimethoprim component)for children more than 3 months of age
    • Placebo matching amoxicillin 10mg/kg once per day for children under 3 months of age
    • Placebo matching nitrofurantoin (1mg/kg) once per day for children with a sulfa allergy.
Study Arms  ICMJE
  • Active Comparator: A
    Eligible children will be randomized to antibiotic prophylaxis. Children under 3 months will receive amoxicillin 10mg/kg once per day. Children >3months will receive Trimethoprim Sulfamethoxazole (2mg/kg Trimethoprim component). Those children with a Sulfa allergy will receive nitrofurantoin (1mg/kg) once per day.
    Intervention: Drug: Trimethoprim Sulfamethoxazole
  • Placebo Comparator: B
    Eligible children will then be randomized to placebo.
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 14, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2008)
140
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children 0 to 12 years of age presenting with first episode of acute pyelonephritis in the absence of vesicoureteral reflux.
  • Acute pyelonephritis defined as presence of fever, a positive urine culture (growth of a single urinary tract pathogen at =10(8) CFU/ml for catheterization specimens and =10(4) CFU/ml for clean catch specimens), and a positive DMSA scan (a discreet defect or generalized decrease in activity).

Exclusion Criteria:

  • Neurogenic bladder
  • anatomic congenital anomaly
  • allergy to all prophylactic antibiotics
  • children whose parents do not wish to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00752375
Other Study ID Numbers  ICMJE 6545
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Darcie Kiddoo, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Canadian Urological Association
Investigators  ICMJE
Principal Investigator: Darcie Kiddoo, MD University of Alberta
PRS Account University of Alberta
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP