PyelonephritisPhase 4NCT00382343
A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux
A Phase 4 study testing Sulfamethoxazole/trimethoprim in people with Pyelonephritis and Renal Scars, run by IRCCS Burlo Garofolo at 7 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 30 months
- Conditions the study is for
- Pyelonephritis, Renal Scars
- What is being tested?
- Sulfamethoxazole/trimethoprim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 7 sitesItaly
- Study dates
- Nov 1999to Mar 2007
- 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 1 day to 30 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Sant'Orsola Hospital
Bologna, Bologna, 48138
Bufalini Hospital
Cesena, Cesena, 47023
San Polo Hospital
Monfalcone, Gorizia, 34170
Santa Maria degli Angeli Hospital
Pordenone, Pordenone, 33170
San Daniele Hospital
San Daniele, Udine, 33100
Sant'Antonio Abate Hospital
Tolmezzo, Udine, 33028
Institute of Child Health IRCCS Burlo Garofolo
Trieste, Trieste, 34137
About this study
Official title: Antibiotic Prophylaxis After Acute Pyelonephritis for Prevention of Urinary Tract Infections in Children With Vesico-Ureteral Reflux.
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).
Read the 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.
- Conditions
- Pyelonephritis, Renal Scars
- Being tested
- Sulfamethoxazole/trimethoprim
- Keywords
- Prevention, Pyelonephritis, Renal scars, Vesico-ureteral reflux, Dimercaptosuccinic acid renal scan (DMSA)
- Medical subject headings
- Pyelonephritis, Vesico-Ureteral Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfamethoxazole/trimethoprimDrug
Sulfamethoxazole/trimethoprim prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: Drug: Sulfamethoxazole/trimethoprim |
| No prophylaxis | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 4 years after enrollment
Secondary outcomes (2)
Renal scars
DMSA renal scan
Measured: 4 years after enrollment
Persistence of vesico-ureteral reflux
Cystourethrography and renal ultrasound
Measured: 4 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startNov 1999
- Primary completionMar 2003
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PyelonephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronfani Luca, IRCCS Burlo Garofolo
- Investigators
- Marco Pennesi, MD, Principal investigator, Institute of Child Health IRCCS Burlo Garofolo, Trieste, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382343
- Sponsor's protocol ID
- RC 35/00
- Status last verified
- Apr 2015
- First submitted
- 28 Sep 2006
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18490378
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis After Acute Pyelonephritis for Prevention of Urinary Tract Infections in Children With Vesico-Ureteral Reflux.
- ClinicalTrials.gov ID
- NCT00382343
- Acronym / sponsor ID
- RC 35/00
- Conditions
- Pyelonephritis, Renal Scars
- Keywords
- Prevention, Pyelonephritis, Renal scars, Vesico-ureteral reflux, Dimercaptosuccinic acid renal scan (DMSA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Nov 1999
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 29 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sulfamethoxazole/trimethoprim | Experimental | Drug: Sulfamethoxazole/trimethoprimAntibiotic 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] |
| No prophylaxis | No intervention | – |
Who may qualify
- Ages
- 1 day to 30 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfamethoxazole/trimethoprimSulfamethoxazole/trimethoprim prophylaxis | Drug | sulfamethoxazole/trimethoprim |
Primary outcome
Recurrence of pyelonephritis
Time frame: up to 4 years after enrollment
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)
2 secondary outcomes
Renal scars
Time frame: 4 years after enrollment
Persistence of vesico-ureteral reflux
Time frame: 4 years after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Results publication: PubMed 18490378Pennesi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Pennesi, MD principal investigator
Institute of Child Health IRCCS Burlo Garofolo, Trieste, Italy
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulfamethoxazole/trimethoprim in people with Pyelonephritis and Renal Scars, run by IRCCS Burlo Garofolo at 7 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 1 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: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrence of pyelonephritis (time frame: up to 4 years after enrollment). 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 NCT00382343, which also lists 1 linked publication.
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 28 Apr 2015.