Urinary Tract Infections in ChildrenNCT03221504
7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children
A study testing Longer therapy duration and Shorter therapy duration in people with Urinary Tract Infections in Children, run by Medical University of Warsaw at 2 sites in Poland.
Trial summary
The investigators aim to assess the effectiveness of a 7-day compared with a 10-day course of antibiotic treatment for febrile urinary tract infections (UTIs) in children. It is formulated a hypothesis that a 7-day course of antibiotic therapy is equally effective as a 10-day course of therapy and would entail a lower… Read more about this study
- Who is it for?
- Ages 3 months to 7 years
- Conditions the study is for
- Urinary Tract Infections in Children
- What is being tested?
- Longer therapy duration and Shorter therapy duration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Jan 2018to 31 Jan 2020
- Phase
- Interventional
- 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 3 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged from 3 months to 7 years
- clinical diagnosis of a febrile UTI at presentation according to urinalysis (white blood cells in the sediment >10 in the field of view);
- fever ≥38°C
- positive urine collection with sensitivity for cefuroxime
- treatment cefuroxime or cefuroxime axetil for 7 days
Who cannot join
- history of a UTI in the last 3 months
- prophylaxis for UTI
- antibiotic therapy in the last month
- known allergy to the study drugs
- immunosuppression therapy
- disease with immune deficiency
- children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis
- severe obstructive uropathy
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Children's Hospital for The Medical University of Warsaw
Warsaw, 02-091
Maria Daniel, MD, 696477117 ext. 0048, maria.daniel@wum.edu.pl
- Recruiting
The Holy Family Specialistic Hospital
Warsaw, 02-544
Maria Daniel, MD
About this study
Official title: 7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children: a Randomized Controlled Trial
The investigators aim to assess the effectiveness of a 7-day compared with a 10-day course of antibiotic treatment for febrile urinary tract infections (UTIs) in children. It is formulated a hypothesis that a 7-day course of antibiotic therapy is equally effective as a 10-day course of therapy and would entail a lower risk of adverse events and better compliance.
Read the detailed description
In previously published European and global guidelines, there has been no consensus among experts regarding the duration of therapy for a febrile UTI. Depending on the recommendation, the duration of treatment should be between 7-14 days.
221 patients aged 3 months to 7 years with febrile UTIs (defined as a combination of fever and leukocyturia in urine sediment) will be randomly assigned to receive a 7-day treatment arm (7 days of cefuroxime/cefuroxime axetil followed by 3 days of blinded placebo) or a 10-day treatment arm (7 days of cefuroxime/cefuroxime axetil followed by 3 days of blinded cefuroxime axetil).
The primary outcome measure will be frequencies of recurrence and reinfection of UTI during the 6 months after the intervention. The secondary outcome measures will be antibiotic-associated diarrhea and compliance.
- Conditions
- Urinary Tract Infections in Children
- Being tested
- Longer therapy duration, Shorter therapy duration
- Keywords
- urinary tract infections, pyelonephritis, cefuroxime, children
- Medical subject headings
- Urinary Tract Infections, Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longer therapy durationOther
Patients will receive cefuroxime axetil orally. Treatment will involve the supply of cefuroxime axetil 30 mg/kg/d in two divided doses (in blinded bottles).
Shorter therapy durationOther
Patients will receive placebo orally (in blinded bottles). The volume of the placebo will be like cefuroxime syrup.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic therapy for 10 days | Active comparator | After 7 days of cefuroxime treatment (oral, intravenous or sequential), patients from day 8 to day 10 will continue to receive the antibiotic (in blinded bottle). Receives: Other: Longer therapy duration |
| Antibiotic therapy for 7 days | Experimental | After 7 days of cefuroxime therapy (oral, intravenous or sequential), children from day 8 to day 10 will receive placebo (in blinded bottle). Receives: Other: Shorter therapy duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequencies of recurrence of UTI
New onset of symptomatic UTI within the 3 months follow-up period. The recurrence of a UTI is diagnosed when the next infection is caused by the same microorganism during 3 months following the treatment of a UTI.
Measured: 3 months after intervention
Secondary outcomes (2)
frequencies of reinfection of UTI
The reinfection of a UTI is diagnosed when the next infection is caused by a different bacteria.
Measured: 6 months after intervention
antibiotic-associated diarrhoea (AAD), compliance
AAD is defined by the daily production of at least 3 loose or watery stools for at least 48 hours during antibiotic treatment and 7 days after administration of the antibiotic.
Compliance with the study protocol will be assessed by direct interview with the patient and/or caregiver and by measuring the amount of the fluid left in the bottle at the end of the intervention.
Measured: 7 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Jan 2018
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infections in ChildrenStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 221 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Pańczyk-Tomaszewska, Assistant Professor, Study chair, Medical Univeristy of WarsawMaria Daniel, MD, Principal investigator, Medical Univeristy of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221504
- Sponsor's protocol ID
- WUM
- Status last verified
- Jul 2017
- First submitted
- 7 Jul 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Simoes e Silva AC, Oliveira EA. Update on the approach of urinary tract infection in childhood. J Pediatr (Rio J). 2015 Nov-Dec;91(6 Suppl 1):S2-10. doi: 10.1016/j.jped.2015.05.003. Epub 2015 Sep 7.
PubMed 26361319Conway PH, Cnaan A, Zaoutis T, Henry BV, Grundmeier RW, Keren R. Recurrent urinary tract infections in children: risk factors and association with prophylactic antimicrobials. JAMA. 2007 Jul 11;298(2):179-86. doi: 10.1001/jama.298.2.179.
PubMed 17622599Craig JC, Simpson JM, Williams GJ, Lowe A, Reynolds GJ, McTaggart SJ, Hodson EM, Carapetis JR, Cranswick NE, Smith G, Irwig LM, Caldwell PH, Hamilton S, Roy LP; Prevention of Recurrent Urinary Tract Infection in Children with Vesicoureteric Reflux and Normal Renal Tracts (PRIVENT) Investigators. Antibiotic prophylaxis and recurrent urinary tract infection in children. N Engl J Med. 2009 Oct 29;361(18):1748-59. doi: 10.1056/NEJMoa0902295.
PubMed 19864673Subcommittee on Urinary Tract Infection, Steering Committee on Quality Improvement and Management; Roberts KB. Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics. 2011 Sep;128(3):595-610. doi: 10.1542/peds.2011-1330. Epub 2011 Aug 28.
PubMed 21873693Montini G, Toffolo A, Zucchetta P, Dall'Amico R, Gobber D, Calderan A, Maschio F, Pavanello L, Molinari PP, Scorrano D, Zanchetta S, Cassar W, Brisotto P, Corsini A, Sartori S, Da Dalt L, Murer L, Zacchello G. Antibiotic treatment for pyelonephritis in children: multicentre randomised controlled non-inferiority trial. BMJ. 2007 Aug 25;335(7616):386. doi: 10.1136/bmj.39244.692442.55. Epub 2007 Jul 4.
PubMed 17611232Michael M, Hodson EM, Craig JC, Martin S, Moyer VA. Short versus standard duration oral antibiotic therapy for acute urinary tract infection in children. Cochrane Database Syst Rev. 2003;(1):CD003966. doi: 10.1002/14651858.CD003966.
PubMed 12535494Ammenti A, Cataldi L, Chimenz R, Fanos V, La Manna A, Marra G, Materassi M, Pecile P, Pennesi M, Pisanello L, Sica F, Toffolo A, Montini G; Italian Society of Pediatric Nephrology. Febrile urinary tract infections in young children: recommendations for the diagnosis, treatment and follow-up. Acta Paediatr. 2012 May;101(5):451-7. doi: 10.1111/j.1651-2227.2011.02549.x. Epub 2012 Jan 3.
PubMed 22122295Daniel M, Szajewska H, Panczyk-Tomaszewska M. 7-day compared with 10-day antibiotic treatment for febrile urinary tract infections in children: protocol of a randomised controlled trial. BMJ Open. 2018 Mar 2;8(3):e019479. doi: 10.1136/bmjopen-2017-019479.
PubMed 29500209
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03221504
- Acronym / sponsor ID
- WUM
- Conditions
- Urinary Tract Infections in Children
- Keywords
- urinary tract infections, pyelonephritis, cefuroxime, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 221 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 18 Jul 2017 (actual)
- 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 investigators aim to assess the effectiveness of a 7-day compared with a 10-day course of antibiotic treatment for febrile urinary tract infections (UTIs) in children. It is formulated a hypothesis that a 7-day course of antibiotic therapy is equally effective as a 10-day course of therapy and would entail a lower risk of adverse events and better compliance.
Detailed description
In previously published European and global guidelines, there has been no consensus among experts regarding the duration of therapy for a febrile UTI. Depending on the recommendation, the duration of treatment should be between 7-14 days.
221 patients aged 3 months to 7 years with febrile UTIs (defined as a combination of fever and leukocyturia in urine sediment) will be randomly assigned to receive a 7-day treatment arm (7 days of cefuroxime/cefuroxime axetil followed by 3 days of blinded placebo) or a 10-day treatment arm (7 days of cefuroxime/cefuroxime axetil followed by 3 days of blinded cefuroxime axetil).
The primary outcome measure will be frequencies of recurrence and reinfection of UTI during the 6 months after the intervention. The secondary outcome measures will be antibiotic-associated diarrhea and compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic therapy for 10 days | Active comparator | Other: Longer therapy durationAfter 7 days of cefuroxime treatment (oral, intravenous or sequential), patients from day 8 to day 10 will continue to receive the antibiotic (in blinded bottle). |
| Antibiotic therapy for 7 days | Experimental | Other: Shorter therapy durationAfter 7 days of cefuroxime therapy (oral, intravenous or sequential), children from day 8 to day 10 will receive placebo (in blinded bottle). |
Who may qualify
- Ages
- 3 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children aged from 3 months to 7 years
- clinical diagnosis of a febrile UTI at presentation according to urinalysis (white blood cells in the sediment >10 in the field of view);
- fever ≥38°C
- positive urine collection with sensitivity for cefuroxime
- treatment cefuroxime or cefuroxime axetil for 7 days
Key exclusion criteria (8 listed)
- history of a UTI in the last 3 months
- prophylaxis for UTI
- antibiotic therapy in the last month
- known allergy to the study drugs
- immunosuppression therapy
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 |
|---|---|---|
| Longer therapy durationPatients will receive cefuroxime axetil orally. Treatment will involve the supply of cefuroxime axetil 30 mg/kg/d in two divided doses (in blinded bottles). | Other | Antibiotic therapy for 10 days |
| Shorter therapy durationPatients will receive placebo orally (in blinded bottles). The volume of the placebo will be like cefuroxime syrup. | Other | Antibiotic therapy for 7 days |
Primary outcome
frequencies of recurrence of UTI
Time frame: 3 months after intervention
New onset of symptomatic UTI within the 3 months follow-up period. The recurrence of a UTI is diagnosed when the next infection is caused by the same microorganism during 3 months following the treatment of a UTI.
2 secondary outcomes
frequencies of reinfection of UTI
Time frame: 6 months after intervention
antibiotic-associated diarrhoea (AAD), compliance
Time frame: 7 days after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Background: PubMed 26361319Simoes e Silva AC, Oliveira EA. Update on the approach of urinary tract infection in childhood. J Pediatr (Rio J). 2015 Nov-Dec;91(6 Suppl 1):S2-10. doi: 10.1016/j.jped.2015.05.003. Epub 2015 Sep 7.
- Background: PubMed 17622599Conway PH, Cnaan A, Zaoutis T, Henry BV, Grundmeier RW, Keren R. Recurrent urinary tract infections in children: risk factors and association with prophylactic antimicrobials. JAMA. 2007 Jul 11;298(2):179-86. doi: 10.1001/jama.298.2.179.
- Background: PubMed 19864673Craig JC, Simpson JM, Williams GJ, Lowe A, Reynolds GJ, McTaggart SJ, Hodson EM, Carapetis JR, Cranswick NE, Smith G, Irwig LM, Caldwell PH, Hamilton S, Roy LP; Prevention of Recurrent Urinary Tract Infection in Children with Vesicoureteric Reflux and Normal Renal Tracts (PRIVENT) Investigators. Antibiotic prophylaxis and recurrent urinary tract infection in children. N Engl J Med. 2009 Oct 29;361(18):1748-59. doi: 10.1056/NEJMoa0902295.
- Background: PubMed 21873693Subcommittee on Urinary Tract Infection, Steering Committee on Quality Improvement and Management; Roberts KB. Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics. 2011 Sep;128(3):595-610. doi: 10.1542/peds.2011-1330. Epub 2011 Aug 28.
- Background: PubMed 17611232Montini G, Toffolo A, Zucchetta P, Dall'Amico R, Gobber D, Calderan A, Maschio F, Pavanello L, Molinari PP, Scorrano D, Zanchetta S, Cassar W, Brisotto P, Corsini A, Sartori S, Da Dalt L, Murer L, Zacchello G. Antibiotic treatment for pyelonephritis in children: multicentre randomised controlled non-inferiority trial. BMJ. 2007 Aug 25;335(7616):386. doi: 10.1136/bmj.39244.692442.55. Epub 2007 Jul 4.
- Background: PubMed 12535494Michael M, Hodson EM, Craig JC, Martin S, Moyer VA. Short versus standard duration oral antibiotic therapy for acute urinary tract infection in children. Cochrane Database Syst Rev. 2003;(1):CD003966. doi: 10.1002/14651858.CD003966.
- Background: PubMed 22122295Ammenti A, Cataldi L, Chimenz R, Fanos V, La Manna A, Marra G, Materassi M, Pecile P, Pennesi M, Pisanello L, Sica F, Toffolo A, Montini G; Italian Society of Pediatric Nephrology. Febrile urinary tract infections in young children: recommendations for the diagnosis, treatment and follow-up. Acta Paediatr. 2012 May;101(5):451-7. doi: 10.1111/j.1651-2227.2011.02549.x. Epub 2012 Jan 3.
- Derived from this study: PubMed 29500209Daniel M, Szajewska H, Panczyk-Tomaszewska M. 7-day compared with 10-day antibiotic treatment for febrile urinary tract infections in children: protocol of a randomised controlled trial. BMJ Open. 2018 Mar 2;8(3):e019479. doi: 10.1136/bmjopen-2017-019479.
- National Institute for Health and Care Excellence. Urinary tract infections in children and young people 2013 JulyLink provided by the sponsor.
- European Association of Urology; European Society for Pediatric Urology Urinary tract infections in children: EAU/ESPU guidelines.Link provided by the sponsor.
- Canadian Paediatric Society, Urinary tract infection in infants and children: Diagnosis and managementLink provided by the sponsor.
- 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.
Malgorzata Pańczyk-Tomaszewska, Assistant Professor study chair
Medical Univeristy of Warsaw
Maria Daniel, MD principal investigator
Medical Univeristy of Warsaw
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Longer therapy duration and Shorter therapy duration in people with Urinary Tract Infections in Children, run by Medical University of Warsaw at 2 sites in Poland.
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 8 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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.
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?
Contact Maria Daniel, MD (+48696477117, maria.daniel@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequencies of recurrence of UTI (time frame: 3 months after intervention). 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 NCT03221504, which also lists 8 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 20 Mar 2018.