Trial record 1 of 1 for:    RIVUR
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Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00405704
First received: November 29, 2006
Last updated: April 15, 2015
Last verified: April 2015
Results First Received: December 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Vesicoureteral Reflux
Urinary Tract Infections
Interventions: Drug: Trimethoprim-Sulfamethoxazole
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Trimethoprim-Sulfamethoxazole Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
Placebo Placebo: Cherry flavored liquid suspension matched to active comparator.

Participant Flow:   Overall Study
    Trimethoprim-Sulfamethoxazole     Placebo  
STARTED     302     305  
Completed Outcome Renal Scan     227     235  
Completed Assessments for New Scarring     220     227  
Outcome Stool Assessed     203     210  
Recurrent UTI With E. Coli     30     57  
Recurrent UTI With TMP-SMZ Panel     38     69  
COMPLETED     261     259  
NOT COMPLETED     41     46  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Trimethoprim-Sulfamethoxazole Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
Placebo Placebo: Cherry flavored liquid suspension matched to active comparator.
Total Total of all reporting groups

Baseline Measures
    Trimethoprim-Sulfamethoxazole     Placebo     Total  
Number of Participants  
[units: participants]
  302     305     607  
Age  
[units: months]
Median ( Inter-Quartile Range )
  12  
  ( 5 to 31 )  
  12  
  ( 6 to 30 )  
  12  
  ( 6 to 31 )  
Gender  
[units: participants]
     
Female     277     281     558  
Male     25     24     49  
Region of Enrollment  
[units: participants]
     
United States     302     305     607  



  Outcome Measures
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1.  Primary:   Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up   [ Time Frame: 2 years ]

2.  Secondary:   Outcome Renal Scarring   [ Time Frame: 2 years ]

3.  Secondary:   Severe Renal Scarring on Outcome Scan   [ Time Frame: 2 years ]

4.  Secondary:   New Renal Scarring on Outcome Scan   [ Time Frame: 2 years ]

5.  Secondary:   Treatment Failure Composite   [ Time Frame: 2 years ]

6.  Secondary:   Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)   [ Time Frame: 2 years ]

7.  Secondary:   Recurrent Febrile or Symptomatic UTI With Resistant E. Coli   [ Time Frame: 2 years ]

8.  Secondary:   Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Results may not apply to children with different demographic or clinical characteristics or in locales where choice of TMP-SMZ may be limited by susceptibility patterns or clinical acceptability. Some subgroup analyses had limited statistical power.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Myra Carpenter, Senior Investigator
Organization: UNC Chapel Hill
phone: 919-962-3245
e-mail: myra_carpenter@unc.edu


Publications of Results:
Other Publications:


Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00405704     History of Changes
Other Study ID Numbers: DK074059 (IND), U01 DK074059
Study First Received: November 29, 2006
Results First Received: December 4, 2014
Last Updated: April 15, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board