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A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux

Primary Purpose

Pyelonephritis, Renal Scars

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Sulfamethoxazole/trimethoprim
Sponsored by
IRCCS Burlo Garofolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pyelonephritis focused on measuring Prevention, Pyelonephritis, Renal scars, Vesico-ureteral reflux, Dimercaptosuccinic acid renal scan (DMSA)

Eligibility Criteria

1 Day - 30 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • presence of vesico-ureteral reflux (VUR) grade II, III or IV, based on the International Classification, mono or bilateral, diagnosed between one day and 30 months of age after a first episode of acute pyelonephritis, or after birth during diagnostic procedures planned as a consequence of prenatal ultrasonographic evidence of pyelectasia.

Exclusion Criteria:

  • previous episodes of urinary tract infection (UTI), even if only suspected (e.g. an episode of fever treated with antibiotics without performing urine culture);
  • VUR grade I, because of the high probability of rapid spontaneous resolution;
  • VUR grade V, as requested by the Technical Scientific Committee, concerned by the high incidence of associated renal dysplasia;
  • recurrence of acute pyelonephritis before the first dimercaptosuccinic acid (DMSA) renal scan, if this was positive for scars.

Sites / Locations

  • San Polo Hospital
  • San Daniele Hospital
  • Sant'Antonio Abate Hospital
  • Sant'Orsola Hospital
  • Bufalini Hospital
  • Santa Maria degli Angeli Hospital
  • Institute of Child Health IRCCS Burlo Garofolo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

sulfamethoxazole/trimethoprim

No prophylaxis

Arm Description

Antibiotic prophylaxis with sulfamethoxazole/trimethoprim [1-2 mg/kg trimethoprim and 5-10 mg/kg sulfamethoxazole once daily]; in case of intolerance (leucopoenia) and for children younger than 6 months: nitrofurantoin [2 mg/kg once daily]

Outcomes

Primary Outcome Measures

Recurrence of pyelonephritis
Urinalysis and urine culture performed at each episode of fever or when symptoms of UTI occurred (eg, change in the smell of urine, anorexia, irritability)

Secondary Outcome Measures

Renal scars
DMSA renal scan
Persistence of vesico-ureteral reflux
Cystourethrography and renal ultrasound

Full Information

First Posted
September 28, 2006
Last Updated
April 27, 2015
Sponsor
IRCCS Burlo Garofolo
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1. Study Identification

Unique Protocol Identification Number
NCT00382343
Brief Title
A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux
Official Title
Antibiotic Prophylaxis After Acute Pyelonephritis for Prevention of Urinary Tract Infections in Children With Vesico-Ureteral Reflux.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Burlo Garofolo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to assess the effectiveness of antibiotic prophylaxis in preventing pyelonephritis and in avoiding the appearance of new scars in a sample of children under 36 months with vesico-ureteral reflux (VUR).
Detailed Description
In recent years, the effectiveness of continuous antibiotic prophylaxis in children with vesico-ureteral reflux (VUR) has been intensely discussed. The question is not only whether antibiotics are effective in preventing recurrent urinary tract infections (UTI), but also whether they alter the natural history of disease and help to prevent the appearance of new kidneys scars. The evidence on the effectiveness of antibiotic prophylaxis is scanty: randomised controlled trials (RCT) published until now are poorly designed and carried out in very heterogeneous samples of children, i.e. spanning from 6 months to 14-18 years of age and pooling patients with and without VUR. A recently updated Cochrane Systematic Review concludes that high quality RCTs are needed to determine the effectiveness of long-term antibiotics for the prevention of UTIs in susceptible children. Moreover, the presence of VUR has not been firmly shown to be a risk factor for recurrence of pyelonephritis, and a direct association between VUR and the presence of scars or the appearance of new scars has not been demonstrated; there is just an association between VUR of grade IV-V and prenatal renal dysplasia, almost exclusively in male infants. In spite of this uncertainty, several practice guidelines recommend long term antibiotic prophylaxis in children with different degrees of VUR. The aim of this study is to assess the effectiveness of antibiotic prophylaxis in preventing pyelonephritis and in avoiding the appearance of new scars in a sample of children under 36 months with VUR. Comparison: In a multicentre trial, 100 patients with VUR diagnosed with cystourethrography after a first episode of acute pyelonephritis or for prenatal evidence of pyelectasia will be assigned randomly to receive prophylaxis or not. Randomization will be carried out using a centralized minimization procedure to balance for sex, age group and VUR grade.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyelonephritis, Renal Scars
Keywords
Prevention, Pyelonephritis, Renal scars, Vesico-ureteral reflux, Dimercaptosuccinic acid renal scan (DMSA)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sulfamethoxazole/trimethoprim
Arm Type
Experimental
Arm Description
Antibiotic prophylaxis with sulfamethoxazole/trimethoprim [1-2 mg/kg trimethoprim and 5-10 mg/kg sulfamethoxazole once daily]; in case of intolerance (leucopoenia) and for children younger than 6 months: nitrofurantoin [2 mg/kg once daily]
Arm Title
No prophylaxis
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Sulfamethoxazole/trimethoprim
Intervention Description
Sulfamethoxazole/trimethoprim prophylaxis
Primary Outcome Measure Information:
Title
Recurrence of pyelonephritis
Description
Urinalysis and urine culture performed at each episode of fever or when symptoms of UTI occurred (eg, change in the smell of urine, anorexia, irritability)
Time Frame
up to 4 years after enrollment
Secondary Outcome Measure Information:
Title
Renal scars
Description
DMSA renal scan
Time Frame
4 years after enrollment
Title
Persistence of vesico-ureteral reflux
Description
Cystourethrography and renal ultrasound
Time Frame
4 years after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: presence of vesico-ureteral reflux (VUR) grade II, III or IV, based on the International Classification, mono or bilateral, diagnosed between one day and 30 months of age after a first episode of acute pyelonephritis, or after birth during diagnostic procedures planned as a consequence of prenatal ultrasonographic evidence of pyelectasia. Exclusion Criteria: previous episodes of urinary tract infection (UTI), even if only suspected (e.g. an episode of fever treated with antibiotics without performing urine culture); VUR grade I, because of the high probability of rapid spontaneous resolution; VUR grade V, as requested by the Technical Scientific Committee, concerned by the high incidence of associated renal dysplasia; recurrence of acute pyelonephritis before the first dimercaptosuccinic acid (DMSA) renal scan, if this was positive for scars.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Pennesi, MD
Organizational Affiliation
Institute of Child Health IRCCS Burlo Garofolo, Trieste, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Polo Hospital
City
Monfalcone
State/Province
Gorizia
ZIP/Postal Code
34170
Country
Italy
Facility Name
San Daniele Hospital
City
San Daniele
State/Province
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Sant'Antonio Abate Hospital
City
Tolmezzo
State/Province
Udine
ZIP/Postal Code
33028
Country
Italy
Facility Name
Sant'Orsola Hospital
City
Bologna
ZIP/Postal Code
48138
Country
Italy
Facility Name
Bufalini Hospital
City
Cesena
ZIP/Postal Code
47023
Country
Italy
Facility Name
Santa Maria degli Angeli Hospital
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Institute of Child Health IRCCS Burlo Garofolo
City
Trieste
ZIP/Postal Code
34137
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18490378
Citation
Pennesi M, Travan L, Peratoner L, Bordugo A, Cattaneo A, Ronfani L, Minisini S, Ventura A; North East Italy Prophylaxis in VUR study group. Is antibiotic prophylaxis in children with vesicoureteral reflux effective in preventing pyelonephritis and renal scars? A randomized, controlled trial. Pediatrics. 2008 Jun;121(6):e1489-94. doi: 10.1542/peds.2007-2652. Epub 2008 May 19.
Results Reference
result

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A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux

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