Infection PreventionNCT07083024
Infection, Prevention and Control: A Multifaceted Approach to Preventing Hospital Acquired Infections Principal
A study of Infection Prevention, run by Queen's University at 1 site in Canada.
Trial summary
Decreasing infections that occur when a person is hospitalized requires effective infection prevention and control (IPAC) practices. Lectures regarding IPAC as a way to provide education may not be effective for nursing students' learning. Other ways of educating nursing students is need. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2023to 23 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Final year Baccalaureate of Nursing Science (BNSc) students
Who cannot join
- Students not enrolled in the BNSc program
Trial locations and contacts
1 site in 1 country.
About this study
Decreasing infections that occur when a person is hospitalized requires effective infection prevention and control (IPAC) practices. Lectures regarding IPAC as a way to provide education may not be effective for nursing students' learning. Other ways of educating nursing students is need. Therefore, the The aim of this study is to evaluate an alternative format of education that includes lectures, hands-on practice, and video scenarios.
Methods: This study uses a quasi-experimental design. Nursing students completing their final year of a Baccalaureate of Nursing program were included. The students attended a IPAC education session that included a lecture, hands-on practice, and a review of video scenarios. After the education session, knowledge was assessed using the post-test and videos related questions answered to demonstrate their ability to identify IPAC practices and lapses.
Read the detailed description
In Canada, Health care associated infections affect more than 200,000 patients each year in Canada. The primary route of transmission of nosocomial pathogens are healthcare workers' hands and a secondary contributor to the transmission of pathogens within the hospital setting is the environment itself. The transmission of pathogens from health care workers and the environment to patients can be reduced through the use of routine infection prevention and control (IPAC) practices including completing a risk assessment, hand hygiene, controlling the environment (disinfecting equipment and surfaces), and the proper use of Personal Protective Equipment (PPE). All healthcare workers are responsible for implementing practices to reduce the spread of infection, including nursing students.
Nurses and nursing students are frequently exposed to blood and bodily fluids, emphasizing the importance of proper IPAC practices. Knowledge regarding IPAC practices varies from satisfactory to disappointing and even when nursing students have the correct knowledge they report rarely performing hand hygiene prior to non-invasive procedures There is a need to develop and implement multi-modal teaching strategies that improve the students' theoretical knowledge of IPAC and allow them to apply these concepts in an educational setting prior to implementing them within the clinical environment.
Different educational modalities including self-guided resources, synchronous teaching, or online modules can be used to provide theoretical nursing knowledge. However, to actively engage students with knowledge through practical application and hands-on experiences. To help bridge the gap between theoretical knowledge and application prior to clinical exposure, various teaching modalities have been proposed. This includes structured education programs, virtual simulation, interactive computer modules and simulated practice. Studies that have implemented these innovative teaching methodologies have demonstrated encouraging results related to IPAC practices.
An improvement in knowledge has been demonstrated in studies with nursing students after the addition of interactive and experiential learning to their didactic lessons. They also reported greater satisfaction with lessons when hands-on modalities allow for decision making without the risk of harm, allow engagement with a hospital-like environment, and reviews materials repeatedly In addition, despite having appropriate education, leadership and environmental cues heavily influence a student's implementation of IPAC practices. Students were more likely to forego the use of PPE when they noticed nurses in the clinical environment were not engaging in standard precautions. Therefore, it is essential to rethink how IPAC practices can be fully integrated into nursing student's routine practices to help mitigate the influence of what they witness in the clinical setting. Although there is a benefit to mixed modality teaching strategies, there is a gap in the literature regarding the effectiveness of an in-class mixed-modality educational session that combines didactic, hands-on practice, and videos on IPAC knowledge.
Aim The aim of this study is to evaluate the effectiveness the effectiveness of an innovative educational session that included didactic education intermingled with hands-on practice, and video scenarios on or final year nursing students' knowledge regarding the key steps in the prevention and control of the spread of infections. This study examined the following questions: for final year nursing students, what is the effect of an innovative IPAC education intervention on (a) change in knowledge regarding IPAC practices and (b) the ability to correctly identify errors in IPAC practices.
Methods This quasi experimental study utilizes a pre-test post-test design with nursing students enrolled in their final practicum at a University in Southern Ontario, Canada. Queen's University Research Ethics Board approval (HSREB# 6038157) was obtained prior to implementing this study.
Sample Final year Baccalaureate of Nursing Science (BNSc) students who were completing their final clinical placement students were invited to participate 24 hours prior to the education session during their regularly scheduled class time. Recruitment was completed by a member of the research team (a Master of Nursing Science student) and did not teach these students or determine their grades. All students were informed that participation in this study was voluntary and anonymous. The course instructor and the members of the research team would not be able to identify if they decided to participate in this study. Students were informed that if they decided not to participate in the study there would be no impact to grades or student success. Students who agreed to participate in this study completed an online consent form and completed a demographic questionnaire, and a pre-test to examine their baseline IPAC knowledge.
Setting The intervention took place during regular class time. All final year BScN students enrolled in the integrated practicum course participated in the IPAC education session, even if they did not participate in the study component.
Intervention
The intervention included an innovative IPAC education session that included didactic education intermingled with hands-on practice, and video scenarios. The IPAC education session was delivered over 2.5 hours and featured didactic education, hands-on practice, and videos scenarios of nurses in a simulated practice setting. The education session was grounded in information available from Public Health Ontario, Health Canada, and the World Health Organization. The video scenarios were developed by the research team and featured common nursing practices delivered in a hospital setting. During the education session the following concepts were explored:
- the 'Chain of Infection' which highlights how infectious agents (viruses, bacteria, and fungi) are transmitted from person to person;
- how to break the "Chain of Infection;"
- effective hand hygiene;
- the use of personal protective equipment (PPE), including masks;
- cleaning versus disinfecting, and wet contact time of disinfectant agents. After each concept was introduced, all students completed a hands-on activity including a group hand hygiene exercise, donning and doffing gown, gloves and mask, and using two different disinfectant wipes (Lysol© = 4 minute wet contact time, and Oxivir TB© = 1 minute wet contact time) to disinfect a table and adhere to the wet contact time. Following the education session, video scenarios were used to engage the students in practice of identifying correct and incorrect IPAC practices. Students watched four videos, see Table 3 for a description of the video scenes.
Following the education session, the students who consented to participate in this study completed questions asking them to identify the correct and incorrect IPAC practices in each of the videos, and complete a post-test to evaluate the students' post-education session knowledge and potential practice change.
Outcome Measures Demographic information, including if students have completed past infection control education (in person or virtual), and if they have cared for patients who are under isolation precautions will be collected. Students will also complete the WHO Hand Hygiene Knowledge Questionnaire for Health-Care Workers. It includes 26 questions, and it is scored by summing the total number of correct answers. It has been used with practicing nurses working in a hospital setting and with nursing and medical students. The questionnaire has demonstrated a high reliability (α = 0.843).
Participants were also asked to report on their hand hygiene intentions and cleaning and disinfecting intention. These were measured using the Declarative Intention of Hand Hygiene Behavior and the Knowledge and Attitudes Regarding Hand Hygiene and Environmental Cleaning/Disinfecting. The Declarative Intention of Hand Hygiene Behavior and the Knowledge and Attitudes Regarding Hand Hygiene is based on the WHO four moments of hand hygiene. It includes 13 items which are recorded on a Likert scale that includes the options of 'never or very rarely'; 'sometimes'; or 'quite often or always.' The Knowledge and Attitudes Regarding Hand Hygiene and Environmental Cleaning/Disinfecting includes 10 items which are recorded on a Likert scale that includes the options of 'completely disagree'; 'somewhat agree'; and 'completely agree" Data Collection All data, including the consent forms were anonymous and were collected using a web-based survey tool (Qualtrics©). The anonymous web-based links to the consent and pre-test and post-test questionnaires were posted on the final year nursing students' course page. All students had access to these links, and had the choice to participate in this study. The course professor had no knowledge regarding which students agreed to participate.
Data Analysis Data was analyzed using Statistical Package for the Social Sciences (SPSS© version 29). Demographic information was analyzed using means, standard deviations, and frequencies. The frequencies were calculated for the Declarative intention of hand hygiene behavior and the Knowledge and Attitudes Regarding Hand Hygiene and Environmental Cleaning/Disinfecting questions. A Kolmogorov-Smirnov test indicated that the results from the pre-test (df = 56, p = 0.16) and the post-test (df = 56, p < 0.01) for the WHO Hand Hygiene Questionnaire (World Health Organization, 2009) did not follow a normal distribution therefore the median pre-test and post-test scores were calculated. To examine if there were any significant changes in knowledge from the pre-test and post-test results a Wilcoxon Signed Rank Test was used.
- Conditions
- Infection Prevention
- Being tested
- infection control education
- Keywords
- education, nursing students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infection control educationBehavioural
This intervention includes a lecture, hands on practice and identifying IPAC practices in videos
| Study group | Role | What they receive |
|---|---|---|
| Usual education | Other | This is the baseline knowledge participants have Receives: Behavioral: infection control education |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO Hand Hygiene Knowledge Questionnaire for Health-Care Workers (World Health Organization, 2009)
It includes 26 questions, and it is scored by summing the total number of correct answers. It has been used with practicing nurses working in a hospital setting and with nursing and medical students. The questionnaire has demonstrated a high reliability (α = 0.843).
Measured: Day 1
Secondary outcomes (1)
Declarative Intention of Hand Hygiene Behavior and the Knowledge and Attitudes Regarding Hand Hygiene and Environmental Cleaning/Disinfecting
The Declarative Intention of Hand Hygiene Behavior and the Knowledge and Attitudes Regarding Hand Hygiene is based on the WHO four moments of hand hygiene. It includes 13 items which are recorded on a Likert scale that includes the options of 'never or very rarely'; 'sometimes'; or 'quite often or always.' The Knowledge and Attitudes Regarding Hand Hygiene and Environmental Cleaning/Disinfecting includes 10 items which are recorded on a Likert scale that includes the options of 'completely disagree'; 'somewhat agree'; and 'completely agree"
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start5 Jan 2023
- Primary completion23 May 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection PreventionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monakshi Sawhney, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083024
- Sponsor's protocol ID
- 6040709
- Status last verified
- Jul 2025
- First submitted
- 26 May 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infection, Prevention and Control: A Multifaceted Approach to Preventing Hospital Acquired Infections Principal
- ClinicalTrials.gov ID
- NCT07083024
- Acronym / sponsor ID
- 6040709
- Conditions
- Infection Prevention
- Keywords
- education, nursing students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 24 Jul 2025 (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.
Decreasing infections that occur when a person is hospitalized requires effective infection prevention and control (IPAC) practices. Lectures regarding IPAC as a way to provide education may not be effective for nursing students' learning. Other ways of educating nursing students is need. Therefore, the The aim of this study is to evaluate an alternative format of education that includes lectures, hands-on practice, and video scenarios.
Methods: This study uses a quasi-experimental design. Nursing students completing their final year of a Baccalaureate of Nursing program were included. The students attended a IPAC education session that included a lecture, hands-on practice, and a review of video scenarios. After the education session, knowledge was assessed using the post-test and videos related questions answered to demonstrate their ability to identify IPAC practices and lapses.
Detailed description
In Canada, Health care associated infections affect more than 200,000 patients each year in Canada. The primary route of transmission of nosocomial pathogens are healthcare workers' hands and a secondary contributor to the transmission of pathogens within the hospital setting is the environment itself. The transmission of pathogens from health care workers and the environment to patients can be reduced through the use of routine infection prevention and control (IPAC) practices including completing a risk assessment, hand hygiene, controlling the environment (disinfecting equipment and surfaces), and the proper use of Personal Protective Equipment (PPE). All healthcare workers are responsible for implementing practices to reduce the spread of infection, including nursing students.
Nurses and nursing students are frequently exposed to blood and bodily fluids, emphasizing the importance of proper IPAC practices. Knowledge regarding IPAC practices varies from satisfactory to disappointing and even when nursing students have the correct knowledge they report rarely performing hand hygiene prior to non-invasive procedures There is a need to develop and implement multi-modal teaching strategies that improve the students' theoretical knowledge of IPAC and allow them to apply these concepts in an educational setting prior to implementing them within the clinical environment.
Different educational modalities including self-guided resources, synchronous teaching, or online modules can be used to provide theoretical nursing knowledge. However, to actively engage students with knowledge through practical application and hands-on experiences. To help bridge the gap between theoretical knowledge and application prior to clinical exposure, various teaching modalities have been proposed. This includes structured education programs, virtual simulation, interactive computer modules and simulated practice. Studies that have implemented these innovative teaching methodologies have demonstrated encouraging results related to IPAC practices.
An improvement in knowledge has been demonstrated in studies with nursing students after the addition of interactive and experiential learning to their didactic lessons. They also reported greater satisfaction with lessons when hands-on modalities allow for decision making without the risk of harm, allow engagement with a hospital-like environment, and reviews materials repeatedly In addition, despite having appropriate education, leadership and environmental cues heavily influence a student's implementation of IPAC practices. Students were more likely to forego the use of PPE when they noticed nurses in the clinical environment were not engaging in standard precautions. Therefore, it is essential to rethink how IPAC practices can be fully integrated into nursing student's routine practices to help mitigate the influence of what they witness in the clinical setting. Although there is a benefit to mixed modality teaching strategies, there is a gap in the literature regarding the effectiveness of an in-class mixed-modality educational session that combines didactic, hands-on practice, and videos on IPAC knowledge.
Aim The aim of this study is to evaluate the effectiveness the effectiveness of an innovative educational session that included didactic education intermingled with hands-on practice, and video scenarios on or final year nursing students' knowledge regarding the key steps in the prevention and control of the spread of infections. This study examined the following questions: for final year nursing students, what is the effect of an innovative IPAC education intervention on (a) change in knowledge regarding IPAC practices and (b) the ability to correctly identify errors in IPAC practices.
Methods This quasi experimental study utilizes a pre-test post-test design with nursing students enrolled in their final practicum at a University in Southern Ontario, Canada. Queen's University Research Ethics Board approval (HSREB# 6038157) was obtained prior to implementing this study.
Sample Final year Baccalaureate of Nursing Science (BNSc) students who were completing their final clinical placement students were invited to participate 24 hours prior to the education session during their regularly scheduled class time. Recruitment was completed by a member of the research team (a Master of Nursing Science student) and did not teach these students or determine their grades. All students were informed that participation in this study was voluntary and anonymous. The course instructor and the members of the research team would not be able to identify if they decided to participate in this study. Students were informed that if they decided not to participate in the study there would be no impact to grades or student success. Students who agreed to participate in this study completed an online consent form and completed a demographic questionnaire, and a pre-test to examine their baseline IPAC knowledge.
Setting The intervention took place during regular class time. All final year BScN students enrolled in the integrated practicum course participated in the IPAC education session, even if they did not participate in the study component.
Intervention
The intervention included an innovative IPAC education session that included didactic education intermingled with hands-on practice, and video scenarios. The IPAC education session was delivered over 2.5 hours and featured didactic education, hands-on practice, and videos scenarios of nurses in a simulated practice setting. The education session was grounded in information available from Public Health Ontario, Health Canada, and the World Health Organization. The video scenarios were developed by the research team and featured common nursing practices delivered in a hospital setting. During the education session the following concepts were explored:
- the 'Chain of Infection' which highlights how infectious agents (viruses, bacteria, and fungi) are transmitted from person to person;
- how to break the "Chain of Infection;"
- effective hand hygiene;
- the use of personal protective equipment (PPE), including masks;
- cleaning versus disinfecting, and wet contact time of disinfectant agents. After each concept was introduced, all students completed a hands-on activity including a group hand hygiene exercise, donning and doffing gown, gloves and mask, and using two different disinfectant wipes (Lysol© = 4 minute wet contact time, and Oxivir TB© = 1 minute wet contact time) to disinfect a table and adhere to the wet contact time. Following the education session, video scenarios were used to engage the students in practice of identifying correct and incorrect IPAC practices. Students watched four videos, see Table 3 for a description of the video scenes.
Following the education session, the students who consented to participate in this study completed questions asking them to identify the correct and incorrect IPAC practices in each of the videos, and complete a post-test to evaluate the students' post-education session knowledge and potential practice change.
Outcome Measures Demographic information, including if students have completed past infection control education (in person or virtual), and if they have cared for patients who are under isolation precautions will be collected. Students will also complete the WHO Hand Hygiene Knowledge Questionnaire for Health-Care Workers. It includes 26 questions, and it is scored by summing the total number of correct answers. It has been used with practicing nurses working in a hospital setting and with nursing and medical students. The questionnaire has demonstrated a high reliability (α = 0.843).
Participants were also asked to report on their hand hygiene intentions and cleaning and disinfecting intention. These were measured using the Declarative Intention of Hand Hygiene Behavior and the Knowledge and Attitudes Regarding Hand Hygiene and Environmental Cleaning/Disinfecting. The Declarative Intention of Hand Hygiene Behavior and the Knowledge and Attitudes Regarding Hand Hygiene is based on the WHO four moments of hand hygiene. It includes 13 items which are recorded on a Likert scale that includes the options of 'never or very rarely'; 'sometimes'; or 'quite often or always.' The Knowledge and Attitudes Regarding Hand Hygiene and Environmental Cleaning/Disinfecting includes 10 items which are recorded on a Likert scale that includes the options of 'completely disagree'; 'somewhat agree'; and 'completely agree" Data Collection All data, including the consent forms were anonymous and were collected using a web-based survey tool (Qualtrics©). The anonymous web-based links to the consent and pre-test and post-test questionnaires were posted on the final year nursing students' course page. All students had access to these links, and had the choice to participate in this study. The course professor had no knowledge regarding which students agreed to participate.
Data Analysis Data was analyzed using Statistical Package for the Social Sciences (SPSS© version 29). Demographic information was analyzed using means, standard deviations, and frequencies. The frequencies were calculated for the Declarative intention of hand hygiene behavior and the Knowledge and Attitudes Regarding Hand Hygiene and Environmental Cleaning/Disinfecting questions. A Kolmogorov-Smirnov test indicated that the results from the pre-test (df = 56, p = 0.16) and the post-test (df = 56, p < 0.01) for the WHO Hand Hygiene Questionnaire (World Health Organization, 2009) did not follow a normal distribution therefore the median pre-test and post-test scores were calculated. To examine if there were any significant changes in knowledge from the pre-test and post-test results a Wilcoxon Signed Rank Test was used.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual education | Other | Behavioral: infection control educationThis is the baseline knowledge participants have |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Final year Baccalaureate of Nursing Science (BNSc) students
Key exclusion criteria (1 listed)
- Students not enrolled in the BNSc program
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 |
|---|---|---|
| infection control educationThis intervention includes a lecture, hands on practice and identifying IPAC practices in videos | Behavioural | Usual education |
Primary outcome
WHO Hand Hygiene Knowledge Questionnaire for Health-Care Workers (World Health Organization, 2009)
Time frame: Day 1
It includes 26 questions, and it is scored by summing the total number of correct answers. It has been used with practicing nurses working in a hospital setting and with nursing and medical students. The questionnaire has demonstrated a high reliability (α = 0.843).
1 secondary outcome
Declarative Intention of Hand Hygiene Behavior and the Knowledge and Attitudes Regarding Hand Hygiene and Environmental Cleaning/Disinfecting
Time frame: Day 1
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 Jul 2025.
Related trials for Infection Prevention
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Infection Prevention, run by Queen's University at 1 site in Canada.
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 1 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 Jul 2025. 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 Canada. 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?
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?
WHO Hand Hygiene Knowledge Questionnaire for Health-Care Workers (World Health Organization, 2009) (time frame: Day 1). 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 28 Jul 2025.