Vesicoureteral RefluxPhase 3PREDICTNCT02021006
Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract
A Phase 3 study testing nitrofurantoin, No prophylaxis and Amoxicillin-Potassium Clavulanate Combination in people with Vesicoureteral Reflux and Renal Hypodysplasia, Nonsyndromic, 1, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. Read more about this study
- Who is it for?
- Ages 1 month to 4 months
- Conditions the study is for
- Vesicoureteral Reflux, Renal Hypodysplasia, Nonsyndromic, 1, Chronic Kidney Disease
- What is being tested?
- nitrofurantoin, No prophylaxis and Amoxicillin-Potassium Clavulanate Combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2013to Jan 2025
- Phase
- Phase 3
- 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 month to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 1 and 4 months (> 4 weeks and <20 weeks of post-natal age)
- Gestational age > 35 weeks
- Glomerular filtration rate (calculated according to Schwartz) > 15 ml/min/1.73 m2
- No previous symptomatic UTI
- Imaging Diagnostic work-up completed and presence of grade III to V vesicoureteral reflux
- Informed consent of parents
Who cannot join
- Age <1 and >4 months
- Gestational age < 35 weeks
- Glomerular filtration rate (calculated according to Schwartz) < 15 ml/min/1.73 m2 at three months of age
- Patients with neurogenic bladder, myelomeningocele, ureteropelvic junction and/or ureterovesical junction obstruction, or other malformations leading to potential voiding disturbances.
- Presence of urethral valves
- Patients with no or low grade reflux (grade I and II).
Show all 10Show fewer
- Hypersensitivity to the all the utilized antimicrobial agent
- Children with serious clinical conditions which, according to the investigator, prevent them from being included in the study cohort.
- Use of experimental drugs in the month previous to the beginning of the study
- Children unable to follow the established protocol procedures or whose parents are unable to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Pediatric Nephrology Dialysis and Transplant Unit IRCCS Ca'Granda
Milan, 20122
About this study
The exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can reduce the risk of urinary tract infection in children with these malformations, this study will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic prophylaxis reduce the risk of urinary tract infections in these children and if urinary tract infections influence the appearance of renal damage.
Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral reflux and that urinary tract infections, in morphologically normal kidneys, will not result in chronic renal failure.
Read the detailed description
Bacterial urinary tract infections (UTI) are common in young children. The presence of fever is considered to be a marker of renal parenchymal involvement. Renal damage during the acute phase of infection may lead to scarring, yet the role that scarring plays in the appearance of chronic kidney failure is unknown. It is also unclear what influence scars have on the natural course of kidney function, especially in children with renal hypodysplasia, with or without vesicoureteral reflux (VUR). Renal hypodysplasia is the most common cause for dialysis and transplantation in the pediatric population.
Patients suffering from recurrent UTIs and VUR have often undergone corrective surgery. For many years, it was also thought necessary to prescribe long-term antibiotic prophylaxis to all children with VUR. These treatment strategies were based on the ideas and opinions of the experts, rather than on hard scientific evidence. As regards the prevention of recurrent UTIs and the subsequent development of renal scarring, a long-term international study on Reflux was not able to demonstrate that surgical correction is more effective than antibiotic prophylaxis. Very little data is available regarding the use of long-term antibiotic prophylaxis in children with high grade reflux with or without renal hypodysplasia.
The use of antibiotics during the first few months of life has been associated with a significant increase in body mass index (BMI). Even though this effect is probably limited, it could have a significant impact on public health given the widespread use of antibiotics and due to the considerable increase in cases of pediatric and adult obesity seen over the last few years.
In spite of the lack of evidence, the use of prophylaxis is largely routine practice in most centres. Therefore, a randomized study is necessary in order to evaluate whether prophylaxis reduces the risk of symptomatic infections and subsequent renal damage.
To assess the role of prophylaxis in patient with high grade vesicoureteral reflux we will perform a multicentre, prospective, randomized, controlled, open-label, study.
Patients enrolled will be randomized in two groups:
Group A: no antibiotic prophylaxis. Group B: antibiotic prophylaxis for 24 months. The choice of which antibiotic to prescribe from the list below is left to the discretion of each investigator, on the basis of local antibiotic resistance patterns.
- nitrofurantoin 1.5-2 mg/kg per day
- amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicillin)
- cefixime 2 mg/kg per day
- trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)
The study is comprised of:
- Phase 1: Pre-randomization - screening tests to determine eligibility for the trial.
- Phase 2: Active treatment - this phase follows randomization and foresees 24 months of antibiotic prophylaxis for Group B and clinical surveillance for Group A.
- Phase 3: Follow-up - a further 36 months of clinical, laboratory and instrumental evaluation of renal function and the progression of renal damage for a total follow-up period of 5 years
- Being tested
- nitrofurantoin, No prophylaxis, Amoxicillin-Potassium Clavulanate Combination, Trimethoprim/sulfamethoxazole, Cefixime
- Keywords
- antibiotic prophylaxis, vesicoureteral reflux, congenital abnormalities of kidney, renal hypodysplasia, chronic kidney disease
- Medical subject headings
- Vesico-Ureteral Reflux, Renal Hypodysplasia, Nonsyndromic, 1, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitrofurantoinDrug
Also called Furadantin
antibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs
Physicians can chose one the following schedules:
- nitrofurantoin 1.5-2 mg/kg per day
- amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline)
- cefixime 2 mg/kg per day
- trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)
No prophylaxisOther
children will be followed, but no antibiotic prophylaxis will be administered
Amoxicillin-Potassium Clavulanate CombinationDrug
Also called amoxicilline/clavulanic acid, augmentin, clavulin
antibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs
Physicians can chose one the following schedules:
- nitrofurantoin 1.5-2 mg/kg per day
- amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline)
- cefixime 2 mg/kg per day
- trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)
Trimethoprim/sulfamethoxazoleDrug
Also called bactrim
antibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs
Physicians can chose one the following schedules:
- nitrofurantoin 1.5-2 mg/kg per day
- amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline)
- cefixime 2 mg/kg per day
- trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)
CefiximeDrug
Also called cefixoral
antibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs
Physicians can chose one the following schedules:
- nitrofurantoin 1.5-2 mg/kg per day
- amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline)
- cefixime 2 mg/kg per day
- trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)
| Study group | Role | What they receive |
|---|---|---|
| ANTIBIOTIC PROPHYLAXIS | Active comparator | Children in this arm will take antibiotic prophylaxis for 2 years. Patients in this arm will do clinical/instrumental follow-up for 5 years.
The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs
Physicians can chose one the following schedules:
* nitrofurantoin 1.5-2 mg/kg per day
* Amoxicillin-Potassium Clavulanate Combination 15 mg/kg per day (dose expressed in units equivalent to amoxicilline)
* cefixime 2 mg/kg per day
* trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim) Receives: Drug: nitrofurantoin; Drug: Amoxicillin-Potassium Clavulanate Combination; Drug: Trimethoprim/sulfamethoxazole; Drug: Cefixime |
| NO PROPHYLAXIS | Experimental | Children in this arm will not take antibiotic prophylaxis. Patients in this arm will do clinical/instrumental follow-up for 5 years Receives: Other: No prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary tract infections rate
Urinary tract infections will be strictly monitored in all enrolled patients (both group A and group B). The rate of urinary tract infections in the first 24 months from the enrolment will be compared between 2 groups
Measured: during the first 24 months from enrolment
Secondary outcomes (8)
febrile urinary tract infections
Febrile urinary tract infections will be strictly monitored in all enrolled patients (both group A and group B). The rate of febrile urinary tract infections in the first 24 months from the enrolment will be compared between 2 groups
Measured: during the first 24 months from enrolment
renal scars
the appearance of renal scars in a dimercaptosuccinic acid (DMSA) scan will be detected at 2 and 5 years from enrolment and compared between the 2 groups.
Measured: at 2 years and 5 years from enrolment
serum creatinine (renal function)
The renal function (serum creatinine) will be monitored for all enrolled patients to explore the appearance and progression of renal damage
Measured: at the enrolment,1 year, 2 years, 3 years, 4 years, 5 years
hypertension
the appearance of hypertension will be monitored at every visit in all enrolled children
Measured: at 4, 8, 12, 18, 24, 36, 48, 60 months from enrolment
proteinuria
the appearance of proteinuria will be monitored at every visit in all enrolled children
Measured: at 4, 8, 12, 18, 24, 36, 48, 60 months from enrolment
body mass index
body mass index will be evaluated at 2 and 5 years of follow-up and it will be correlated to the use of antibiotic prophylaxis
Measured: at 2 and 5 years from enrolment
serum cystatin C (renal function)
The renal function (serum cystatin-C) will be monitored for all enrolled patients to explore the appearance and progression of renal damage
Measured: at the enrolment,1 year, 2 years, 3 years, 4 years, 5 years
modification in gut microbiota induced by continuous antibiotic exposure during the first months of life
A stool sample will be collected, frozen and stored for gut microbiota and resistome profile analysis
Measured: at the enrollment, 4 months, 8 months, 12 months, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2020
- Study completionJan 2025 (estimated)
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 Vesicoureteral RefluxStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministero della Salute, Italy, IL Sogno di Stefano
- Responsible party
- Principal investigator, Giovanni Montini, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Giovanni Montini, MD, Study chair, Pediatric Nephrology, Dialysis and Transplant Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico MilanFranz Schaefer, Professor, Study director, Center for Pediatrics and Adolescent Medicine Division of Pediatric Nephrology, Heidelberg, GermanyOtto Mehls, Professor, Principal investigator, Center for Pediatrics and Adolescent Medicine Division of Pediatric Nephrology, Heidelberg, GermanyLutz T. Weber, Professor, Principal investigator, Ärztlicher Leiter der Kindernephrologie Klinik und Poliklinik für Kinder- und Jugendmedizin Uniklinik Köln - KölnAleksandra M Zurowska, Professor, Principal investigator, Medical University of Gdansk, Department Paediatric & Adolescent Nephrology & Hypertension - Gdansk - PolandFatos Yalcinkaya, Professor, Principal investigator, Department of Pediatric Nephrology, School of Medicine, Ankara University, Ankara, TurkeyEsra Baskin, Professor, Principal investigator, Paediatric Nephrology Division, Department of Paediatrics, Faculty of Medicine, Baskent University, Ankara, TurkeyEnrico Verrina, MD, Principal investigator, UOC Nefrologia, Dialisi e Trapianto, IRCCS Giannina Gaslini, Genova, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021006
- Sponsor's protocol ID
- PREDICT trial
- Acronym
- PREDICT
- Status last verified
- Sep 2023
- First submitted
- 1 Dec 2013
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Morello W, Baskin E, Jankauskiene A, Yalcinkaya F, Zurowska A, Puccio G, Serafinelli J, La Manna A, Krzemien G, Pennesi M, La Scola C, Becherucci F, Brugnara M, Yuksel S, Mekahli D, Chimenz R, De Palma D, Zucchetta P, Vajauskas D, Drozdz D, Szczepanska M, Caliskan S, Lombet J, Minoli DG, Guarino S, Gulleroglu K, Ruzgiene D, Szmigielska A, Barbi E, Ozcakar ZB, Kranz A, Pasini A, Materassi M, De Rechter S, Ariceta G, Weber LT, Marzuillo P, Alberici I, Taranta-Janusz K, Caldas Afonso A, Tkaczyk M, Catala M, Cabrera Sevilla JE, Mehls O, Schaefer F, Montini G; PREDICT Study Group. Antibiotic Prophylaxis in Infants with Grade III, IV, or V Vesicoureteral Reflux. N Engl J Med. 2023 Sep 14;389(11):987-997. doi: 10.1056/NEJMoa2300161. Epub 2023 Sep 12.
PubMed 37702442
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract
- ClinicalTrials.gov ID
- NCT02021006
- Acronym / sponsor ID
- PREDICT / PREDICT trial
- Keywords
- antibiotic prophylaxis, vesicoureteral reflux, congenital abnormalities of kidney, renal hypodysplasia, chronic kidney disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Ministero della Salute, Italy, IL Sogno di Stefano
- Study start
- Dec 2013
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2025 (estimated)
- First posted
- 27 Dec 2013 (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 exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can reduce the risk of urinary tract infection in children with these malformations, this study will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic prophylaxis reduce the risk of urinary tract infections in these children and if urinary tract infections influence the appearance of renal damage.
Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral reflux and that urinary tract infections, in morphologically normal kidneys, will not result in chronic renal failure.
Detailed description
Bacterial urinary tract infections (UTI) are common in young children. The presence of fever is considered to be a marker of renal parenchymal involvement. Renal damage during the acute phase of infection may lead to scarring, yet the role that scarring plays in the appearance of chronic kidney failure is unknown. It is also unclear what influence scars have on the natural course of kidney function, especially in children with renal hypodysplasia, with or without vesicoureteral reflux (VUR). Renal hypodysplasia is the most common cause for dialysis and transplantation in the pediatric population.
Patients suffering from recurrent UTIs and VUR have often undergone corrective surgery. For many years, it was also thought necessary to prescribe long-term antibiotic prophylaxis to all children with VUR. These treatment strategies were based on the ideas and opinions of the experts, rather than on hard scientific evidence. As regards the prevention of recurrent UTIs and the subsequent development of renal scarring, a long-term international study on Reflux was not able to demonstrate that surgical correction is more effective than antibiotic prophylaxis. Very little data is available regarding the use of long-term antibiotic prophylaxis in children with high grade reflux with or without renal hypodysplasia.
The use of antibiotics during the first few months of life has been associated with a significant increase in body mass index (BMI). Even though this effect is probably limited, it could have a significant impact on public health given the widespread use of antibiotics and due to the considerable increase in cases of pediatric and adult obesity seen over the last few years.
In spite of the lack of evidence, the use of prophylaxis is largely routine practice in most centres. Therefore, a randomized study is necessary in order to evaluate whether prophylaxis reduces the risk of symptomatic infections and subsequent renal damage.
To assess the role of prophylaxis in patient with high grade vesicoureteral reflux we will perform a multicentre, prospective, randomized, controlled, open-label, study.
Patients enrolled will be randomized in two groups:
Group A: no antibiotic prophylaxis. Group B: antibiotic prophylaxis for 24 months. The choice of which antibiotic to prescribe from the list below is left to the discretion of each investigator, on the basis of local antibiotic resistance patterns.
- nitrofurantoin 1.5-2 mg/kg per day
- amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicillin)
- cefixime 2 mg/kg per day
- trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)
The study is comprised of:
- Phase 1: Pre-randomization - screening tests to determine eligibility for the trial.
- Phase 2: Active treatment - this phase follows randomization and foresees 24 months of antibiotic prophylaxis for Group B and clinical surveillance for Group A.
- Phase 3: Follow-up - a further 36 months of clinical, laboratory and instrumental evaluation of renal function and the progression of renal damage for a total follow-up period of 5 years
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANTIBIOTIC PROPHYLAXIS | Active comparator | Drug: nitrofurantoin, Drug: Amoxicillin-Potassium Clavulanate Combination, Drug: Trimethoprim/sulfamethoxazole, Drug: CefiximeChildren in this arm will take antibiotic prophylaxis for 2 years. Patients in this arm will do clinical/instrumental follow-up for 5 years. The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs Physicians can chose one the following schedules: * nitrofurantoin 1.5-2 mg/kg per day * Amoxicillin-Potassium Clavulanate Combination 15 mg/kg per day (dose expressed in units equivalent to amoxicilline) * cefixime 2 mg/kg per day * trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim) |
| NO PROPHYLAXIS | Experimental | Other: No prophylaxisChildren in this arm will not take antibiotic prophylaxis. Patients in this arm will do clinical/instrumental follow-up for 5 years |
Who may qualify
- Ages
- 1 month to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age between 1 and 4 months (> 4 weeks and <20 weeks of post-natal age)
- Gestational age > 35 weeks
- Glomerular filtration rate (calculated according to Schwartz) > 15 ml/min/1.73 m2
- No previous symptomatic UTI
- Imaging Diagnostic work-up completed and presence of grade III to V vesicoureteral reflux
Key exclusion criteria (10 listed)
- Age <1 and >4 months
- Gestational age < 35 weeks
- Glomerular filtration rate (calculated according to Schwartz) < 15 ml/min/1.73 m2 at three months of age
- Patients with neurogenic bladder, myelomeningocele, ureteropelvic junction and/or ureterovesical junction obstruction, or other malformations leading to potential voiding disturbances.
- Presence of urethral valves
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 |
|---|---|---|
| nitrofurantoinAlso: Furadantinantibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs Physicians can chose one the following schedules: * nitrofurantoin 1.5-2 mg/kg per day * amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline) * cefixime 2 mg/kg per day * trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim) | Drug | ANTIBIOTIC PROPHYLAXIS |
| No prophylaxischildren will be followed, but no antibiotic prophylaxis will be administered | Other | NO PROPHYLAXIS |
| Amoxicillin-Potassium Clavulanate CombinationAlso: amoxicilline/clavulanic acid, augmentin, clavulinantibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs Physicians can chose one the following schedules: * nitrofurantoin 1.5-2 mg/kg per day * amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline) * cefixime 2 mg/kg per day * trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim) | Drug | ANTIBIOTIC PROPHYLAXIS |
| Trimethoprim/sulfamethoxazoleAlso: bactrimantibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs Physicians can chose one the following schedules: * nitrofurantoin 1.5-2 mg/kg per day * amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline) * cefixime 2 mg/kg per day * trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim) | Drug | ANTIBIOTIC PROPHYLAXIS |
| CefiximeAlso: cefixoralantibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs Physicians can chose one the following schedules: * nitrofurantoin 1.5-2 mg/kg per day * amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline) * cefixime 2 mg/kg per day * trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim) | Drug | ANTIBIOTIC PROPHYLAXIS |
Primary outcome
urinary tract infections rate
Time frame: during the first 24 months from enrolment
Urinary tract infections will be strictly monitored in all enrolled patients (both group A and group B). The rate of urinary tract infections in the first 24 months from the enrolment will be compared between 2 groups
8 secondary outcomes
febrile urinary tract infections
Time frame: during the first 24 months from enrolment
renal scars
Time frame: at 2 years and 5 years from enrolment
serum creatinine (renal function)
Time frame: at the enrolment,1 year, 2 years, 3 years, 4 years, 5 years
hypertension
Time frame: at 4, 8, 12, 18, 24, 36, 48, 60 months from enrolment
proteinuria
Time frame: at 4, 8, 12, 18, 24, 36, 48, 60 months from enrolment
body mass index
Time frame: at 2 and 5 years from enrolment
serum cystatin C (renal function)
Time frame: at the enrolment,1 year, 2 years, 3 years, 4 years, 5 years
modification in gut microbiota induced by continuous antibiotic exposure during the first months of life
Time frame: at the enrollment, 4 months, 8 months, 12 months, 2 years, 3 years, 4 years, 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 37702442Morello W, Baskin E, Jankauskiene A, Yalcinkaya F, Zurowska A, Puccio G, Serafinelli J, La Manna A, Krzemien G, Pennesi M, La Scola C, Becherucci F, Brugnara M, Yuksel S, Mekahli D, Chimenz R, De Palma D, Zucchetta P, Vajauskas D, Drozdz D, Szczepanska M, Caliskan S, Lombet J, Minoli DG, Guarino S, Gulleroglu K, Ruzgiene D, Szmigielska A, Barbi E, Ozcakar ZB, Kranz A, Pasini A, Materassi M, De Rechter S, Ariceta G, Weber LT, Marzuillo P, Alberici I, Taranta-Janusz K, Caldas Afonso A, Tkaczyk M, Catala M, Cabrera Sevilla JE, Mehls O, Schaefer F, Montini G; PREDICT Study Group. Antibiotic Prophylaxis in Infants with Grade III, IV, or V Vesicoureteral Reflux. N Engl J Med. 2023 Sep 14;389(11):987-997. doi: 10.1056/NEJMoa2300161. Epub 2023 Sep 12.
- Individual participant dataSharing planned: Undecided
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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.
Giovanni Montini, MD study chair
Pediatric Nephrology, Dialysis and Transplant Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan
Franz Schaefer, Professor study director
Center for Pediatrics and Adolescent Medicine Division of Pediatric Nephrology, Heidelberg, Germany
Otto Mehls, Professor principal investigator
Center for Pediatrics and Adolescent Medicine Division of Pediatric Nephrology, Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nitrofurantoin, No prophylaxis and Amoxicillin-Potassium Clavulanate Combination in people with Vesicoureteral Reflux and Renal Hypodysplasia, Nonsyndromic, 1, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site 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 6 inclusion and 10 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
urinary tract infections rate (time frame: during the first 24 months from enrolment). 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 NCT02021006, 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 Sep 2023.