Antibiotic ProphylaxisPhase 4APPrUVNCT05438082
Antibiotic Prophylaxis to Prevent Post-procedure UTI After VCUG
A Phase 4 study testing Antibiotic Prophylaxis in people with Antibiotic Prophylaxis and Voiding Cystourethrogram, run by Hamilton Health Sciences Corporation.
Trial summary
The current practice of pre-VCUG antibiotic prophylaxis is highly variable. A recent unpublished survey of Society of Fetal Urologists (SFU) completed by this study team found that 87% of respondents reported having patients who develop fUTI following VCUG, with 30% of respondents prophylaxing for fUTI in patients… Read more about this study
- Who is it for?
- Ages Up to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Prophylaxis, Voiding Cystourethrogram, Febrile Urinary Tract Infection
- What is being tested?
- Antibiotic Prophylaxis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Dec 2024
- 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 Up to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children <3 years of age undergoing VCUG for the following indications: high-grade SFU/UTD hydronephrosis, ureteral dilatation, or bladder abnormalities found during renal ultrasound
- Parent or legal guardian able to provide informed consent
Who cannot join
- Chronic antibiotic use
- Allergy to Trimethoprim or Trimethoprim-Sulfamethoxazole
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Antibiotic Prophylaxis to Prevent Post-procedure Urinary Tract Infection After Voiding Cystourethrogram
The current practice of pre-VCUG antibiotic prophylaxis is highly variable. A recent unpublished survey of Society of Fetal Urologists (SFU) completed by this study team found that 87% of respondents reported having patients who develop fUTI following VCUG, with 30% of respondents prophylaxing for fUTI in patients undergoing VCUG. The current lack of best practice guidelines regarding antibiotic prophylaxis prior to VCUG due to low quality of current literature, and a growing concern around risks of unnecessary antibiotic exposure suggests the need for an RCT. The results of this pilot trial will inform the ability to conduct a definitive RCT on this important subject. The results of the definitive trial would have important clinical and economic implications.
Read the detailed description
What are the Study Objectives? The primary objective of this pilot trial is to determine the feasibility of conducting a definitive trial investigating whether pre-VCUG antibiotic prophylaxis, when compared to placebo, decreases the risk of fUTI in infants undergoing VCUG for genitourinary abnormalities. The pilot trial will address specific feasibility outcomes including process, resources, management and scientific domains. The pilot will lay the groundwork for the eventual full trial. Funding for the full trial will be sought after preliminary data is collected from the pilot study.
The primary objective for the definitive trial is to determine whether single-dose, preprocedural antibiotic prophylaxis compared to placebo lowers the risk of fUTI in children < 3 years of age who are undergoing VCUG for the following indications: high-grade (SFU Classification III, IV/UTD 2,3) HN, ureteral dilatation, or bladder abnormalities found during renal ultrasound. The secondary outcomes of the definitive trial will include assessment of adverse event outcomes related to antibiotic prophylaxis administration, including antibiotic resistant UTI pathogens, episodes of antibiotic associated diarrhea, and C. difficile.
- Being tested
- Antibiotic Prophylaxis, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic ProphylaxisDrug
This trial will contain two arms in which patients will be randomized to receive one dose of either Trimethoprim (if < 2 months) or Trimethoprim-Sulfamethoxazole (if ≥ 2 months) or placebo in suspension. Dosing regimen for the active treatment (Trimethoprim) will be based on weight (5mg/kg of Trimethoprim component) with a maximum dosage of 320mg
PlaceboOther
The placebo group will receive an equal volume of placebo suspension that has been developed to have the same colour and taste as the antibiotic to preserve blinding.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic Prophylaxis | Experimental | one dose of either Trimethoprim (if < 2 months) or Trimethoprim-Sulfamethoxazole (if ≥ 2 months) or placebo in suspension. Dosing regimen for the active treatment (Trimethoprim) will be based on weight (5mg/kg of Trimethoprim component) with a maximum dosage of 320mg. Receives: Drug: Antibiotic Prophylaxis |
| Placebo | Placebo comparator | The placebo group will receive an equal volume of placebo suspension that has been developed to have the same colour and taste as the antibiotic to preserve blinding. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of pilot study: randomization, compliance, enrollment targets
The primary feasibility outcomes for the pilot study will be recruitment rate (>50% of eligible infants enrolled), randomization rate (percentage of participants randomized, >95%), medication compliance rate (>80%), percentage of the primary endpoints (febrile UTI) and cost of being in the trial per patient. We would also aim to demonstrate a <15% rate of protocol violations, and loss to follow-up. The major clinical outcome for the pilot study is to determine the event rate of UTI in patient post-procedure to inform the sample size calculation for the larger trial.
Measured: 12 months
Secondary outcomes (2)
Resource Allocation
Secondary outcomes in the pilot study will be adequacy of research resource allocation, to understand if further study supports are required for the eventual multi-centre trial. Management outcomes include determining research coordinator capacity, processing times for each enrollment, and follow-up, time required for adjudication UTI events, and ensuring adequacy and accuracy of data management. We will also aim to understand potential barriers to recruitment, and compliance. Adverse events related to antibiotic use for patients will be recorded as well.
Measured: 12 months
Febrile UTI within 7 days of VCUG Procedure
Patients will be enrolled in the study for 7 days post VCUG, which is clinically considered the immediate post-procedure period.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic ProphylaxisStudies 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
- Model description
- This trial is a single center, parallel, blinded, randomized, placebo-controlled pilot trial in children
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Khan, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438082
- Sponsor's protocol ID
- 19481
- Acronym
- APPrUV
- Status last verified
- Apr 2023
- First submitted
- 24 Jun 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis to Prevent Post-procedure Urinary Tract Infection After Voiding Cystourethrogram
- ClinicalTrials.gov ID
- NCT05438082
- Acronym / sponsor ID
- APPrUV / 19481
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Jun 2022 (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 current practice of pre-VCUG antibiotic prophylaxis is highly variable. A recent unpublished survey of Society of Fetal Urologists (SFU) completed by this study team found that 87% of respondents reported having patients who develop fUTI following VCUG, with 30% of respondents prophylaxing for fUTI in patients undergoing VCUG. The current lack of best practice guidelines regarding antibiotic prophylaxis prior to VCUG due to low quality of current literature, and a growing concern around risks of unnecessary antibiotic exposure suggests the need for an RCT. The results of this pilot trial will inform the ability to conduct a definitive RCT on this important subject. The results of the definitive trial would have important clinical and economic implications.
Detailed description
What are the Study Objectives? The primary objective of this pilot trial is to determine the feasibility of conducting a definitive trial investigating whether pre-VCUG antibiotic prophylaxis, when compared to placebo, decreases the risk of fUTI in infants undergoing VCUG for genitourinary abnormalities. The pilot trial will address specific feasibility outcomes including process, resources, management and scientific domains. The pilot will lay the groundwork for the eventual full trial. Funding for the full trial will be sought after preliminary data is collected from the pilot study.
The primary objective for the definitive trial is to determine whether single-dose, preprocedural antibiotic prophylaxis compared to placebo lowers the risk of fUTI in children < 3 years of age who are undergoing VCUG for the following indications: high-grade (SFU Classification III, IV/UTD 2,3) HN, ureteral dilatation, or bladder abnormalities found during renal ultrasound. The secondary outcomes of the definitive trial will include assessment of adverse event outcomes related to antibiotic prophylaxis administration, including antibiotic resistant UTI pathogens, episodes of antibiotic associated diarrhea, and C. difficile.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is a single center, parallel, blinded, randomized, placebo-controlled pilot trial in children
| Arm | Type | Receives |
|---|---|---|
| Antibiotic Prophylaxis | Experimental | Drug: Antibiotic Prophylaxisone dose of either Trimethoprim (if < 2 months) or Trimethoprim-Sulfamethoxazole (if ≥ 2 months) or placebo in suspension. Dosing regimen for the active treatment (Trimethoprim) will be based on weight (5mg/kg of Trimethoprim component) with a maximum dosage of 320mg. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo group will receive an equal volume of placebo suspension that has been developed to have the same colour and taste as the antibiotic to preserve blinding. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children <3 years of age undergoing VCUG for the following indications: high-grade SFU/UTD hydronephrosis, ureteral dilatation, or bladder abnormalities found during renal ultrasound
- Parent or legal guardian able to provide informed consent
Key exclusion criteria (2 listed)
- Chronic antibiotic use
- Allergy to Trimethoprim or Trimethoprim-Sulfamethoxazole
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 |
|---|---|---|
| Antibiotic ProphylaxisThis trial will contain two arms in which patients will be randomized to receive one dose of either Trimethoprim (if < 2 months) or Trimethoprim-Sulfamethoxazole (if ≥ 2 months) or placebo in suspension. Dosing regimen for the active treatment (Trimethoprim) will be based on weight (5mg/kg of Trimethoprim component) with a maximum dosage of 320mg | Drug | Antibiotic Prophylaxis |
| PlaceboThe placebo group will receive an equal volume of placebo suspension that has been developed to have the same colour and taste as the antibiotic to preserve blinding. | Other | Placebo |
Primary outcome
Feasibility of pilot study: randomization, compliance, enrollment targets
Time frame: 12 months
The primary feasibility outcomes for the pilot study will be recruitment rate (>50% of eligible infants enrolled), randomization rate (percentage of participants randomized, >95%), medication compliance rate (>80%), percentage of the primary endpoints (febrile UTI) and cost of being in the trial per patient. We would also aim to demonstrate a <15% rate of protocol violations, and loss to follow-up. The major clinical outcome for the pilot study is to determine the event rate of UTI in patient post-procedure to inform the sample size calculation for the larger trial.
2 secondary outcomes
Resource Allocation
Time frame: 12 months
Febrile UTI within 7 days of VCUG Procedure
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotic Prophylaxis in people with Antibiotic Prophylaxis and Voiding Cystourethrogram, run by Hamilton Health Sciences Corporation.
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 2 inclusion and 2 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Sarah Khan, MD (9055212100 ext. 77577, khan259@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of pilot study: randomization, compliance, enrollment targets (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2023.