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Urinary Tract InfectionsPhase 4NCT00156546

Evaluation of the Effectiveness of Antibiotic Prophylaxis in Children With a Previous Urinary Tract Infection

A Phase 4 study testing antibiotic to reduce the recurrence of infection in people with Urinary Tract Infections, run by University of Padova at 16 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Our hypothesis is that long-term antimicrobial prophylaxis does not reduce the recurrence of infection and the risk of appearance of kidney scars in children with a documented previous upper UTI. Read more about this study

Who is it for?
Ages 2 months to 6 years
Conditions the study is for
Urinary Tract Infections
What is being tested?
antibiotic to reduce the recurrence of infection
How many people
660 participants
Where
16 sitesItaly
Study dates
May 2000to Jul 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 months to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age between 2 months and 6 years
  • Creatinine clearance (calculated according to Schwartz)  70 ml/min/1.73 m2 (for children in their first year of life, serum creatinine levels within normal range for age and sex)
  • First documented upper UTI (diagnostic criteria in Table 1)
  • Imaging Diagnostic work-up completed (Table 2) with at least the presence of an acute lesion at the DMSA scan and or a primary non severe reflux ( 1st or 3rd degree)
  • Informed consent of parents

Who cannot join

  • Patients with chronic renal insufficiency or  30% relative function of one kidney at DMSA scan
  • Patients with urinary tract disorders, such as vesico-ureteral reflux due to complex malformations of the urinary tract, obstruction of the posterior urethra, ureterocele or single kidney, neurogenic bladder
  • Patients with reflux  4th degree
  • Patients with pyelonephritis that developed during prophylaxis instituted because of prenatal diagnosis of urinary tract dilatation  Hypersensitivity to one of the two selected antimicrobial agents

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Italy16 sites

  • Pediatric Unit, Ospedale di Belluno

    Belluno, Belluno

  • Pediatric Unit, Ospedale di Bentivoglio

    Bentivoglio, Bologna

  • Pediatric Department, Ospedale Maggiore

    Bologna

  • - Pediatric Department, Ospedale di Bolzano

    Bolzano, Bolzano

  • Pediatric Unit, Ospedale di Castelfranco

    Castelfranco Veneto, Treviso

  • Pediatric Unit, Ospedale di Cuneo

    Cuneo, Cuneo

  • Pediatric Unit, Ospedale di Dolo

    Dolo, Venezia

  • Pediatric Unit, Ospedale di Mestre

    Mestre Venezia

  • Pediatric Unit, Ospedale di Este - Monselice

    Monselice, Padova

  • Pediatric Unit, Ospedale di Motta di Livenza

    Motta Di Livenza Oderzo, Treviso

  • Nephrology, Dialysis and transplant Unit Pediatric Depatment,

    Padova, Padova, 35128

  • Pediatric Unit, Ospedale di Piove di Sacco e Chioggia

    Piove di Sacco, Padova

  • Pediatric Unit, Ospedale di Ravenna

    Ravenna, Ravenna

  • Pediatric Unit, Ospedale di Soave

    Soave, Verona

  • Pediatric Unit, Ospedale di Schio/Thiene

    Thiene, Vicenza

  • Pediatric Unit, Ospedale di Verona

    Verona

Other trials in Italy

About this study

Official title: Evaluation of the Effectiveness of Antibiotic Prophylaxis in Children With a History of Upper Urinary Tract Infections:a Multicentre Randomised Study

Our hypothesis is that long-term antimicrobial prophylaxis does not reduce the recurrence of infection and the risk of appearance of kidney scars in children with a documented previous upper UTI.

Read the detailed description

Background

Upper urinary tract infections (UTI) are common in children, especially when functional and anatomical abnormalities of the urinary tract co-exist, such as vesico-ureteral reflux (VUR), urinary tract obstruction uropathy and bladder dysfunction. They are associated with the risk of long-term complications, including permanent renal damage (renal scarring), which occurs in 15% of cases. The objective of the diagnosis and medical treatment of UTI in children is the prevention of such complications. Medical treatment includes long-term antimicrobial prophylaxis to be continued for periods ranging from 6 months to 2 years. Recent studies have revealed the emergence of therapy-induced resistance. A review of the literature has highlighted the lack of properly designed, large clinical trials, demonstrating the efficacy of long-term low-dose antimicrobial prophylaxis in terms of reduction in UTI recurrence.

Methods and design

The study is a controlled, randomised, open-label, 3-armed, parallel-group clinical trial comparing no prophylaxis (group 1) with prophylaxis with co-trimoxazole 15 mg/kg daily (group 2) and with amoxicillin + clavulanic acid 15 mg/kg daily (group 3) for 12 months.

Assuming that the incidence of recurrences is 20%, defining efficacy as an incidence of 10% per group and setting  error = 0.05 and power = 90%, 220 patients per group (i.e. a total of 660 patients) are required The study population will consist of children aged between 2 months and 6 years, with normal renal function (creatinine clearance  70 ml/min/1.73m2) and a first episode of documented UTI, who presents at least one of the following: an acute pyelonephritic lesion at the DMSA scan and/or a VUR at the baseline micturating cystography.

Patients will be followed-up for 12 months. Urinalysis and urine cultures will be performed every month and clinical examinations after 6 and 12 months; both will be performed whenever UTI is suspected. Sonography, Doppler sonography (optional) and DMSA scintigraphy will be performed at baseline and at the end of the study.

Being tested
antibiotic to reduce the recurrence of infection
Keywords
Urinary tract infections, Children, Antibiotic prophylaxis, Renal scintigraphy, Vesico ureteral reflux
Medical subject headings
Urinary Tract Infections, Vesico-Ureteral Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • antibiotic to reduce the recurrence of infectionDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary end-point is UTI Recurrence Rate during the 12-month observation period and the Development of renal damage (parenchymal scar) after 12 months.

Secondary outcomes (1)

  1. The secondary objectives are the comparison, in terms of efficacy and effectiveness, between two antimicrobial agents that are currently approved for prophylactic use: co-trimoxazole 15 mg/kg daily versus amoxicillin + clavulanic acid 15 mg/kg daily.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startMay 2000
  3. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
660 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00156546
Sponsor's protocol ID
IRIS 2
Status last verified
Sep 2005
First submitted
7 Sep 2005
Last updated
1 Dec 2005
Results posted
No

Publications

  • Chon CH, Lai FC, Shortliffe LM. Pediatric urinary tract infections. Pediatr Clin North Am. 2001 Dec;48(6):1441-59. doi: 10.1016/s0031-3955(05)70385-0.

    PubMed 11732124

  • Benfield MR, McDonald R, Sullivan EK, Stablein DM, Tejani A. The 1997 Annual Renal Transplantation in Children Report of the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS). Pediatr Transplant. 1999 May;3(2):152-67. doi: 10.1034/j.1399-3046.1999.00011.x.

    PubMed 10389139

  • Wennerstrom M, Hansson S, Jodal U, Stokland E. Primary and acquired renal scarring in boys and girls with urinary tract infection. J Pediatr. 2000 Jan;136(1):30-4. doi: 10.1016/s0022-3476(00)90045-3.

    PubMed 10636970

  • Hoberman A, Wald ER, Hickey RW, Baskin M, Charron M, Majd M, Kearney DH, Reynolds EA, Ruley J, Janosky JE. Oral versus initial intravenous therapy for urinary tract infections in young febrile children. Pediatrics. 1999 Jul;104(1 Pt 1):79-86. doi: 10.1542/peds.104.1.79.

    PubMed 10390264

  • Downs SM. Technical report: urinary tract infections in febrile infants and young children. The Urinary Tract Subcommittee of the American Academy of Pediatrics Committee on Quality Improvement. Pediatrics. 1999 Apr;103(4):e54. doi: 10.1542/peds.103.4.e54.

    PubMed 10103346

  • Hohenfellner K, Hunley TE, Brezinska R, Brodhag P, Shyr Y, Brenner W, Habermehl P, Kon V. ACE I/D gene polymorphism predicts renal damage in congenital uropathies. Pediatr Nephrol. 1999 Aug;13(6):514-8. doi: 10.1007/s004670050649.

    PubMed 10452281

  • Bollgren I. Antibacterial prophylaxis in children with urinary tract infection. Acta Paediatr Suppl. 1999 Nov;88(431):48-52. doi: 10.1111/j.1651-2227.1999.tb01318.x.

    PubMed 10588271

  • Williams G, Lee A, Craig J. Antibiotics for the prevention of urinary tract infection in children: A systematic review of randomized controlled trials. J Pediatr. 2001 Jun;138(6):868-74. doi: 10.1067/mpd.2001.113785.

    PubMed 11391331

  • Williams GJ, Lee A, Craig JC. Long-term antibiotics for preventing recurrent urinary tract infection in children. Cochrane Database Syst Rev. 2001;(4):CD001534. doi: 10.1002/14651858.CD001534.

    PubMed 11687116

  • Ghiro L, Cracco AT, Sartor M, Comacchio S, Zacchello G, Dall'Amico R; Veneto Urinary Tract Infection Study Group. Retrospective study of children with acute pyelonephritis. Evaluation of bacterial etiology, antimicrobial susceptibility, drug management and imaging studies. Nephron. 2002 Jan;90(1):8-15. doi: 10.1159/000046308.

    PubMed 11744799

  • Montini G, Rigon L, Zucchetta P, Fregonese F, Toffolo A, Gobber D, Cecchin D, Pavanello L, Molinari PP, Maschio F, Zanchetta S, Cassar W, Casadio L, Crivellaro C, Fortunati P, Corsini A, Calderan A, Comacchio S, Tommasi L, Hewitt IK, Da Dalt L, Zacchello G, Dall'Amico R; IRIS Group. Prophylaxis after first febrile urinary tract infection in children? A multicenter, randomized, controlled, noninferiority trial. Pediatrics. 2008 Nov;122(5):1064-71. doi: 10.1542/peds.2007-3770.

    PubMed 18977988

  • Hewitt IK, Zucchetta P, Rigon L, Maschio F, Molinari PP, Tomasi L, Toffolo A, Pavanello L, Crivellaro C, Bellato S, Montini G. Early treatment of acute pyelonephritis in children fails to reduce renal scarring: data from the Italian Renal Infection Study Trials. Pediatrics. 2008 Sep;122(3):486-90. doi: 10.1542/peds.2007-2894.

    PubMed 18762516

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing antibiotic to reduce the recurrence of infection in people with Urinary Tract Infections, run by University of Padova at 16 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary end-point is UTI Recurrence Rate during the 12-month observation period and the Development of renal damage (parenchymal scar) after 12 months.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00156546, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2005.

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