Evidence-based PracticesNCT05877105
Effect of Selected Evidence-based Practices and Related Nurses' Education on the Incidence and Severity of Ventilator-associated Pneumonia
A study testing Ventilator-associated pneumonia prevention Evidence-based practices (VAPPEBP) which consists of ten items bundle in people with Evidence-based Practices and Nursing Education, run by Cairo University at 1 site in Egypt.
Trial summary
Background: Invasive mechanical ventilation (MV) is used as a cornerstone in the treatment plan of intensive care units (ICUs) patients to provide adequate tissue oxygenation to support the body during the treatment course. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Evidence-based Practices, Nursing Education, Incidence
- What is being tested?
- Ventilator-associated pneumonia prevention Evidence-based practices (VAPPEBP) which consists of ten items bundle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- 17 May 2023to 30 Nov 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients intubated mechanical ventilation for more than 48 hours
- Also, the ICU staff (medical or nurses) working in the selected ICU will be invited to participate in this study to learn and implement the ten VAP preventive bundles.
Who cannot join
- Patients intubated outside the IFH.
- patients have immunocompromised diseases will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Background:
Invasive mechanical ventilation (MV) is used as a cornerstone in the treatment plan of intensive care units (ICUs) patients to provide adequate tissue oxygenation to support the body during the treatment course.
Read more
Ventilator-associated pneumonia (VAP) is a preventable iatrogenic complication that can develop in patients undergoing mechanical ventilation. VAP is pneumonia that develops 2 days after endotracheal intubation; the patient must have new or progressive radiological infiltrate, infection alerts (e.g. fever, white blood cell count change), altered sputum characters, and isolation of a causative organism, all together to diagnose VAP. VAP is the most frequent hospital-acquired infection occurring in the ICUs and has a high associated mortality rate. Mortality rate for VAP ranges from 24-51%.
Therefore, this study aims to evaluate the VAP preventive effect of the selected EPB and related nurses' education on the incidence and severity of VAP, as well as assess the nurses' compliance with the selected VAP preventive EBP
Hypothesis:
H1: Implementation of VAP prevention EBP and related nurses' education would reduce the incidence of VAP among mechanically ventilated patients compared to those receiving conventional care.
H2: Implementation of VAP prevention EBP and related nurses' education would reduce the severity of VAP among mechanically ventilated patients compared to those receiving conventional care.
Research question:
Q1: What level of compliance do ICU staff have with implementing of VAP prevention EBP?
Trial design The current study will utilize a prospective, longitudinal, single-arm design, pre \& post-experimental. The research's purpose, risks, and potential benefits will be explained to all participants before their voluntary consent and recruitment into the study. Participation was completely voluntary, and written informed consent was obtained from all participants or their families.
ICU nurses will receive tutorial sessions, including four hours of theory and six hours of clinical training in the clinical setting. The tutorial sessions will cover the proper implementation of ten VAP preventive bundles as an EVB. The clinical training will use a demonstration and redemonstration approach to learning to ensure that they understand and can implement the ten VAP preventive bundles efficiently.
Participants sample and setting The study will be held at the ICU of the National Hepatology and Tropical Medicine Research Institute (Imbaba Fever Hospital) (NHTMRI-IFH), Giza, Egypt. The total capacity of the ICUs is 20 beds.
Data collection procedure After obtaining ethical and administrative approval, informed consent will be obtained from eligible patients. The pre-experimental phase will be started by assessing VAP incidence and severity among the participating MV patients using tools 1 and 2, as well as ICU staff compliance to implement the VAP preventive bundle utilizing tool 3 as baseline data for 30-40 days. After finishing the pre-assessment, the following week will be considered washing time before starting the post-experimental time to ensure that all pre-assessment patients are discharged. During the washing time, the nurses will receive a tutorial session on how to implement the adopted VAP preventive bundle, and then the medical and nursing staff will start implementing the VAP preventive bundle in the post-experimental phase for 30-40 days. Tools 1, 2, and 3 will be utilized to evaluate VAP incidence, severity, and ICU staff compliance to implement the VAP preventive bundle. All data will be collected in an Excel sheet for potential statistical analysis.
Read the detailed description
Background:
Invasive mechanical ventilation (MV) is used as a cornerstone in the treatment plan of intensive care units (ICUs) patients to provide adequate tissue oxygenation to support the body during the treatment course.
Ventilator-associated pneumonia (VAP) is a preventable iatrogenic complication that can develop in patients undergoing mechanical ventilation. VAP is pneumonia that develops 2 days after endotracheal intubation; the patient must have new or progressive radiological infiltrate, infection alerts (e.g. fever, white blood cell count change), altered sputum characters, and isolation of a causative organism, all together to diagnose VAP. VAP is the most frequent hospital-acquired infection occurring in the ICUs and has a high associated mortality rate. Mortality rate for VAP ranges from 24-51%.
Therefore, this study aims to evaluate the VAP preventive effect of the selected EPB and related nurses' education on the incidence and severity of VAP, as well as assess the nurses' compliance with the selected VAP preventive EBP
Hypothesis:
H1: Implementation of VAP prevention EBP and related nurses' education would reduce the incidence of VAP among mechanically ventilated patients compared to those receiving conventional care.
H2: Implementation of VAP prevention EBP and related nurses' education would reduce the severity of VAP among mechanically ventilated patients compared to those receiving conventional care.
Research question:
Q1: What level of compliance do ICU staff have with implementing of VAP prevention EBP?
Trial design The current study will utilize a prospective, longitudinal, single-arm design, pre \& post-experimental. The research's purpose, risks, and potential benefits will be explained to all participants before their voluntary consent and recruitment into the study. Participation was completely voluntary, and written informed consent was obtained from all participants or their families.
ICU nurses will receive tutorial sessions, including four hours of theory and six hours of clinical training in the clinical setting. The tutorial sessions will cover the proper implementation of ten VAP preventive bundles as an EVB. The clinical training will use a demonstration and redemonstration approach to learning to ensure that they understand and can implement the ten VAP preventive bundles efficiently.
Participants sample and setting The study will be held at the ICU of the National Hepatology and Tropical Medicine Research Institute (Imbaba Fever Hospital) (NHTMRI-IFH), Giza, Egypt. The total capacity of the ICUs is 20 beds.
Regards to the ICU patients, 72 patients estimated by G power software V.3.1.9.4 (Psychonomic Society, Madison, Wisconsin, USA) with α = 0.05, power (1-β err prob) = 0.80, and effect size = 0.6. Also, eight participants will be added as anticipated dropout during the time of data collection. Hence the total targeted sample size will be 80 patients (40 in each group). Also, all ICU staff (nurses and doctors) working in the selected ICU will be invited to participate in this study to learn and implement the ten VAP preventive bundles.
Data collection procedure After obtaining ethical and administrative approval, informed consent will be obtained from eligible patients. The pre-experimental phase will be started by assessing VAP incidence and severity among the participating MV patients using tools 1 and 2, as well as ICU staff compliance to implement the VAP preventive bundle utilizing tool 3 as baseline data for 30-40 days. After finishing the pre-assessment, the following week will be considered washing time before starting the post-experimental time to ensure that all pre-assessment patients are discharged. During the washing time, the nurses will receive a tutorial session on how to implement the adopted VAP preventive bundle, and then the medical and nursing staff will start implementing the VAP preventive bundle in the post-experimental phase for 30-40 days. Tools 1, 2, and 3 will be utilized to evaluate VAP incidence, severity, and ICU staff compliance to implement the VAP preventive bundle. All data will be collected in an Excel sheet for potential statistical analysis.
- Being tested
- Ventilator-associated pneumonia prevention Evidence-based practices (VAPPEBP) which consists of ten items bundle
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator-associated pneumonia prevention Evidence-based practices (VAPPEBP) which consists of ten items bundleOther
VAP prevention EBP which consists of ten items bundle; hand hygiene, head-of-bed elevation, oral care with cetylpyridinium chloride, avoidance of oversedation, proper breathing circuit management, appropriate maintenance of endotracheal tube cuff pressure, closed system and subglottic suctioning, daily assessment for extubation, early ambulation and rehabilitation, and peptic ulcer and deep vein thrombosis (DVT) prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| pre-experimental | No intervention | assessment of MV patients for VAP incidence and severity ICU staff for will be assessed for Compliance with implementing VAP prevention EBP |
| experimental | Experimental | The intervention group of patients will receive the proposed VAP prevention EBP which consists of ten items bundle.
also, assessment of MV patients for VAP incidence and severity ICU staff for will be assessed for Compliance with implementing VAP prevention EBP Receives: Other: Ventilator-associated pneumonia prevention Evidence-based practices (VAPPEBP) which consists of ten items bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of the selected EPB and related nurses' education on the incidence VAP
VAP incidence will be measured using the diagnostic criteria for clinically defined pneumonia outlined by the Centres for Disease Control and Prevention of the United States (TOOL 1) [3]. The ICU specialist will made a final diagnosis of VAP based on chest imaging test results, clinical signs/symptoms, and laboratory findings. VAP incidence will be measured every day for MV patients using tool 1.
Measured: 35-40 days
Secondary outcomes (2)
Evaluate the effect of the selected EPB and related nurses' education on the severity of VAP
The severity of VAP will be determined by sequential organ failure assessment (SOFA) scores [9]. During a patient's stay in the intensive care unit (ICU), the SOFA scoring system employs six reproducible variables per organ system to assess the disease's severity. Vincent et al. developed it in 1996 [9]. Each organ system was assigned a score between 0 (normal) and 4 (most abnormal), with a minimum of 0 and a maximum of 24. We will evaluate the SOFA scores for the patients on ICU admission, the first day of MV connection, every day of VAP development, and on ICU discharge (if applicable).
Measured: 35-40 days
Assess the compliance of ICU staff with implementing VAP prevention bundel as an EBP
VAPPCC is an advanced tool formulated by researchers in terms of the proposed VAP prevention EBP (ten bundle). VAPPCC consists of ten items, including the satisfactory criteria for each item. The ICU staff's compliance for each item ranged from 1 (yes) to 0 (no), with a minimum score of 0 and a maximum of 10. The charge nurse will use VAPPCC to assess the provided care for MV patients daily.
Measured: 35-40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start17 May 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence-based PracticesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- certain VAP bundle as an evidence-based practice will be implemented as the intervention also the needed related nursing education will be given to ensure that the intervention will be implemented properly, and we will examine its effect on VAP incidence and severity among the intervention group as a dependent variable; then, we will compare the finding against the comparative no intervention group who receives the traditional care. Two arms (intervention and non-intervention comparative groups)
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Elhabashy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877105
- Sponsor's protocol ID
- NHTMRI-13/23
- Status last verified
- Jan 2024
- First submitted
- 17 May 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Selected Evidence-based Practices and Related Nurses' Education on the Incidence and Severity of Ventilator-associated Pneumonia
- ClinicalTrials.gov ID
- NCT05877105
- Acronym / sponsor ID
- NHTMRI-13/23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 26 May 2023 (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.
Background:
Invasive mechanical ventilation (MV) is used as a cornerstone in the treatment plan of intensive care units (ICUs) patients to provide adequate tissue oxygenation to support the body during the treatment course.
Ventilator-associated pneumonia (VAP) is a preventable iatrogenic complication that can develop in patients undergoing mechanical ventilation. VAP is pneumonia that develops 2 days after endotracheal intubation; the patient must have new or progressive radiological infiltrate, infection alerts (e.g. fever, white blood cell count change), altered sputum characters, and isolation of a causative organism, all together to diagnose VAP. VAP is the most frequent hospital-acquired infection occurring in the ICUs and has a high associated mortality rate. Mortality rate for VAP ranges from 24-51%.
Therefore, this study aims to evaluate the VAP preventive effect of the selected EPB and related nurses' education on the incidence and severity of VAP, as well as assess the nurses' compliance with the selected VAP preventive EBP
Hypothesis:
H1: Implementation of VAP prevention EBP and related nurses' education would reduce the incidence of VAP among mechanically ventilated patients compared to those receiving conventional care.
H2: Implementation of VAP prevention EBP and related nurses' education would reduce the severity of VAP among mechanically ventilated patients compared to those receiving conventional care.
Research question:
Q1: What level of compliance do ICU staff have with implementing of VAP prevention EBP?
Trial design The current study will utilize a prospective, longitudinal, single-arm design, pre \& post-experimental. The research's purpose, risks, and potential benefits will be explained to all participants before their voluntary consent and recruitment into the study. Participation was completely voluntary, and written informed consent was obtained from all participants or their families.
ICU nurses will receive tutorial sessions, including four hours of theory and six hours of clinical training in the clinical setting. The tutorial sessions will cover the proper implementation of ten VAP preventive bundles as an EVB. The clinical training will use a demonstration and redemonstration approach to learning to ensure that they understand and can implement the ten VAP preventive bundles efficiently.
Participants sample and setting The study will be held at the ICU of the National Hepatology and Tropical Medicine Research Institute (Imbaba Fever Hospital) (NHTMRI-IFH), Giza, Egypt. The total capacity of the ICUs is 20 beds.
Data collection procedure After obtaining ethical and administrative approval, informed consent will be obtained from eligible patients. The pre-experimental phase will be started by assessing VAP incidence and severity among the participating MV patients using tools 1 and 2, as well as ICU staff compliance to implement the VAP preventive bundle utilizing tool 3 as baseline data for 30-40 days. After finishing the pre-assessment, the following week will be considered washing time before starting the post-experimental time to ensure that all pre-assessment patients are discharged. During the washing time, the nurses will receive a tutorial session on how to implement the adopted VAP preventive bundle, and then the medical and nursing staff will start implementing the VAP preventive bundle in the post-experimental phase for 30-40 days. Tools 1, 2, and 3 will be utilized to evaluate VAP incidence, severity, and ICU staff compliance to implement the VAP preventive bundle. All data will be collected in an Excel sheet for potential statistical analysis.
Detailed description
Background:
Invasive mechanical ventilation (MV) is used as a cornerstone in the treatment plan of intensive care units (ICUs) patients to provide adequate tissue oxygenation to support the body during the treatment course.
Ventilator-associated pneumonia (VAP) is a preventable iatrogenic complication that can develop in patients undergoing mechanical ventilation. VAP is pneumonia that develops 2 days after endotracheal intubation; the patient must have new or progressive radiological infiltrate, infection alerts (e.g. fever, white blood cell count change), altered sputum characters, and isolation of a causative organism, all together to diagnose VAP. VAP is the most frequent hospital-acquired infection occurring in the ICUs and has a high associated mortality rate. Mortality rate for VAP ranges from 24-51%.
Therefore, this study aims to evaluate the VAP preventive effect of the selected EPB and related nurses' education on the incidence and severity of VAP, as well as assess the nurses' compliance with the selected VAP preventive EBP
Hypothesis:
H1: Implementation of VAP prevention EBP and related nurses' education would reduce the incidence of VAP among mechanically ventilated patients compared to those receiving conventional care.
H2: Implementation of VAP prevention EBP and related nurses' education would reduce the severity of VAP among mechanically ventilated patients compared to those receiving conventional care.
Research question:
Q1: What level of compliance do ICU staff have with implementing of VAP prevention EBP?
Trial design The current study will utilize a prospective, longitudinal, single-arm design, pre \& post-experimental. The research's purpose, risks, and potential benefits will be explained to all participants before their voluntary consent and recruitment into the study. Participation was completely voluntary, and written informed consent was obtained from all participants or their families.
ICU nurses will receive tutorial sessions, including four hours of theory and six hours of clinical training in the clinical setting. The tutorial sessions will cover the proper implementation of ten VAP preventive bundles as an EVB. The clinical training will use a demonstration and redemonstration approach to learning to ensure that they understand and can implement the ten VAP preventive bundles efficiently.
Participants sample and setting The study will be held at the ICU of the National Hepatology and Tropical Medicine Research Institute (Imbaba Fever Hospital) (NHTMRI-IFH), Giza, Egypt. The total capacity of the ICUs is 20 beds.
Regards to the ICU patients, 72 patients estimated by G power software V.3.1.9.4 (Psychonomic Society, Madison, Wisconsin, USA) with α = 0.05, power (1-β err prob) = 0.80, and effect size = 0.6. Also, eight participants will be added as anticipated dropout during the time of data collection. Hence the total targeted sample size will be 80 patients (40 in each group). Also, all ICU staff (nurses and doctors) working in the selected ICU will be invited to participate in this study to learn and implement the ten VAP preventive bundles.
Data collection procedure After obtaining ethical and administrative approval, informed consent will be obtained from eligible patients. The pre-experimental phase will be started by assessing VAP incidence and severity among the participating MV patients using tools 1 and 2, as well as ICU staff compliance to implement the VAP preventive bundle utilizing tool 3 as baseline data for 30-40 days. After finishing the pre-assessment, the following week will be considered washing time before starting the post-experimental time to ensure that all pre-assessment patients are discharged. During the washing time, the nurses will receive a tutorial session on how to implement the adopted VAP preventive bundle, and then the medical and nursing staff will start implementing the VAP preventive bundle in the post-experimental phase for 30-40 days. Tools 1, 2, and 3 will be utilized to evaluate VAP incidence, severity, and ICU staff compliance to implement the VAP preventive bundle. All data will be collected in an Excel sheet for potential statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- certain VAP bundle as an evidence-based practice will be implemented as the intervention also the needed related nursing education will be given to ensure that the intervention will be implemented properly, and we will examine its effect on VAP incidence and severity among the intervention group as a dependent variable; then, we will compare the finding against the comparative no intervention group who receives the traditional care. Two arms (intervention and non-intervention comparative groups)
| Arm | Type | Receives |
|---|---|---|
| pre-experimental | No intervention | –assessment of MV patients for VAP incidence and severity ICU staff for will be assessed for Compliance with implementing VAP prevention EBP |
| experimental | Experimental | Other: Ventilator-associated pneumonia prevention Evidence-based practices (VAPPEBP) which consists of ten items bundleThe intervention group of patients will receive the proposed VAP prevention EBP which consists of ten items bundle. also, assessment of MV patients for VAP incidence and severity ICU staff for will be assessed for Compliance with implementing VAP prevention EBP |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ICU patients intubated mechanical ventilation for more than 48 hours
- Also, the ICU staff (medical or nurses) working in the selected ICU will be invited to participate in this study to learn and implement the ten VAP preventive bundles.
Key exclusion criteria (2 listed)
- Patients intubated outside the IFH.
- patients have immunocompromised diseases will be excluded.
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 |
|---|---|---|
| Ventilator-associated pneumonia prevention Evidence-based practices (VAPPEBP) which consists of ten items bundleVAP prevention EBP which consists of ten items bundle; hand hygiene, head-of-bed elevation, oral care with cetylpyridinium chloride, avoidance of oversedation, proper breathing circuit management, appropriate maintenance of endotracheal tube cuff pressure, closed system and subglottic suctioning, daily assessment for extubation, early ambulation and rehabilitation, and peptic ulcer and deep vein thrombosis (DVT) prophylaxis. | Other | experimental |
Primary outcome
Evaluate the effect of the selected EPB and related nurses' education on the incidence VAP
Time frame: 35-40 days
VAP incidence will be measured using the diagnostic criteria for clinically defined pneumonia outlined by the Centres for Disease Control and Prevention of the United States (TOOL 1) [3]. The ICU specialist will made a final diagnosis of VAP based on chest imaging test results, clinical signs/symptoms, and laboratory findings. VAP incidence will be measured every day for MV patients using tool 1.
2 secondary outcomes
Evaluate the effect of the selected EPB and related nurses' education on the severity of VAP
Time frame: 35-40 days
Assess the compliance of ICU staff with implementing VAP prevention bundel as an EBP
Time frame: 35-40 days
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 9 Jan 2024.
- 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.
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 testing Ventilator-associated pneumonia prevention Evidence-based practices (VAPPEBP) which consists of ten items bundle in people with Evidence-based Practices and Nursing Education, run by Cairo University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 9 Jan 2024. 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 Egypt. 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?
Evaluate the effect of the selected EPB and related nurses' education on the incidence VAP (time frame: 35-40 days). 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 9 Jan 2024.