Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
IRCCS Burlo Garofolo Identifier:
First received: September 28, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted

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).

Condition Intervention Phase
Renal Scars
Drug: sulfamethoxazole/trimethoprim or nitrofurantoin prophylaxis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Antibiotic Prophylaxis After Acute Pyelonephritis for Prevention of Urinary Tract Infections in Children With Vesico-Ureteral Reflux.

Resource links provided by NLM:

Further study details as provided by IRCCS Burlo Garofolo:

Primary Outcome Measures:
  • Recurrence of pyelonephritis
  • Renal scars

Secondary Outcome Measures:
  • Persistence of vesico-ureteral reflux

Estimated Enrollment: 96
Study Start Date: November 1999
Estimated Study Completion Date: May 2006
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.


Ages Eligible for Study:   up to 30 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00382343

San Polo Hospital
Monfalcone, Gorizia, Italy, 34170
San Daniele Hospital
San Daniele, Udine, Italy, 33100
Sant'Antonio Abate Hospital
Tolmezzo, Udine, Italy, 33028
Sant'Orsola Hospital
Bologna, Italy, 48138
Bufalini Hospital
Cesena, Italy, 47023
Santa Maria degli Angeli Hospital
Pordenone, Italy, 33170
Institute of Child Health IRCCS Burlo Garofolo
Trieste, Italy, 34137
Sponsors and Collaborators
IRCCS Burlo Garofolo
Principal Investigator: Marco Pennesi, MD Institute of Child Health IRCCS Burlo Garofolo, Trieste, Italy
  More Information

No publications provided by IRCCS Burlo Garofolo

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00382343     History of Changes
Other Study ID Numbers: RC 35/00
Study First Received: September 28, 2006
Last Updated: September 28, 2006
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS Burlo Garofolo:
Renal scars
Vesico-ureteral reflux
Dimercaptosuccinic acid renal scan (DMSA)

Additional relevant MeSH terms:
Vesico-Ureteral Reflux
Kidney Diseases
Nephritis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses processed this record on November 20, 2014