NCT00382343

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 1999

Longer than P75 for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

3.3 years

First QC Date

September 28, 2006

Last Update Submit

April 27, 2015

Conditions

PyelonephritisRenal Scars

Keywords

PreventionPyelonephritisRenal scarsVesico-ureteral refluxDimercaptosuccinic acid renal scan (DMSA)

Outcome Measures

Primary Outcomes (1)

  • 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)

    up to 4 years after enrollment

Secondary Outcomes (2)

  • Renal scars

    4 years after enrollment

  • Persistence of vesico-ureteral reflux

    4 years after enrollment

Study Arms (2)

sulfamethoxazole/trimethoprim

EXPERIMENTAL

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 \[2 mg/kg once daily\]

Drug: Sulfamethoxazole/trimethoprim

No prophylaxis

NO INTERVENTION

Interventions

Sulfamethoxazole/trimethoprimDRUG

Sulfamethoxazole/trimethoprim prophylaxis

sulfamethoxazole/trimethoprim

Eligibility Criteria

Age1 Day - 30 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Sant'Orsola Hospital

Bologna, Bologna, 48138, Italy

Location

Bufalini Hospital

Cesena, Cesena, 47023, Italy

Location

San Polo Hospital

Monfalcone, Gorizia, 34170, Italy

Location

Santa Maria degli Angeli Hospital

Pordenone, Pordenone, 33170, Italy

Location

Institute of Child Health IRCCS Burlo Garofolo

Trieste, Trieste, 34137, Italy

Location

San Daniele Hospital

San Daniele, Udine, 33100, Italy

Location

Sant'Antonio Abate Hospital

Tolmezzo, Udine, 33028, Italy

Location

Related Publications (1)

  • 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.

    PMID: 18490378RESULT

MeSH Terms

Conditions

PyelonephritisVesico-Ureteral Reflux

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Nephritis, InterstitialNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPyelitisMale Urogenital DiseasesUrinary Bladder Diseases

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Marco Pennesi, MD

    Institute of Child Health IRCCS Burlo Garofolo, Trieste, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

November 1, 1999

Primary Completion

March 1, 2003

Study Completion

March 1, 2007

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

IT(7)