TonsillitisASP-ThroatNCT03408704
Antimicrobial Stewardship Program (ASP) in Patients With a Sore Throat
A study testing ASP in people with Tonsillitis and Streptococcus Pharyngitis, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The investigators have developed an antibiotic stewardship program (ASP) to increase adherence to the Swedish guidelines for managing patients with a sore throat. This is a randomized controlled trial where primary health care centers are randomised to get the ASP or not. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tonsillitis, Streptococcus Pharyngitis, Sore Throat
- What is being tested?
- ASP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSweden
- Study dates
- 17 Jan 2018to 28 Feb 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being a primary health care center in the Vastra Gotaland region, Sweden accepting participation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of an Antimicrobial Stewardship Program (ASP) in Primary Health Care in the Management of Patients With a Sore Throat
The investigators have developed an antibiotic stewardship program (ASP) to increase adherence to the Swedish guidelines for managing patients with a sore throat. This is a randomized controlled trial where primary health care centers are randomised to get the ASP or not. The adherence to the Swedish guidelines are measured in all participating centers.
Read the detailed description
The investigators have developed an antibiotic stewardship program (ASP) to increase adherence to the Swedish guidelines for managing patients with a sore throat. This is a randomized controlled trial where primary health care centers are randomised to get the ASP or not. The adherence to the Swedish guidelines are measured in all participating centers 6 months before and after implementation of the ASP. The ASP consists of educational meetings at the clinic for medical practitioners and nurses being informed about current guidelines, seeing their clinics adherence to the guidelines as well as discussing cases.
- Being tested
- ASP
- Keywords
- Streptococcus Pyogenes Infection, Randomized Controlled Trial
- Medical subject headings
- Tonsillitis, Pharyngitis, Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASPOther
It consists of one educational session where doctors and staff at the center discuss current guidelines around management of patients attending for a sore throat. At the education the following is discussed:
- The Swedish guidelines
- Example of cases
- Statistics from previous 6 month showing how well this clinic adheres to the Swedish guidelines.
| Study group | Role | What they receive |
|---|---|---|
| ASP-arm | Experimental | This group of primary health care centers get the internal education (ASP). Receives: Other: ASP |
| Control-arm | No intervention | No intervention at all. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 6m
The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed antibiotics (J01 excluding methenamine) for a sore throat where a rapid antigen detection test (RADT) to detect Group A Streptococcus (GAS) is taken and is positive. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date.
The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
Measured: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months
The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 12m
The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed antibiotics (J01 excluding methenamine) for a sore throat where a rapid antigen detection test (RADT) to detect Group A Streptococcus (GAS) is taken and is positive. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date.
The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
Measured: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months
The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 18m
The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed antibiotics (J01 excluding methenamine) for a sore throat where a rapid antigen detection test (RADT) to detect Group A Streptococcus (GAS) is taken and is positive. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date.
The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
Measured: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months
Secondary outcomes (12)
The effect of an ASP on the change in proportion of negative RADT given AB - 6m
The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed antibiotics (J01 excluding methenamine) for a sore throat where a rapid antigen detection test (RADT) to detect Group A Streptococcus (GAS) is taken and is negative being. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date.
The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
Measured: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months
The effect of an ASP on the change in proportion of negative RADT given AB - 12m
The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed antibiotics (J01 excluding methenamine) for a sore throat where a rapid antigen detection test (RADT) to detect Group A Streptococcus (GAS) is taken and is negative being. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date.
The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
Measured: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months
The effect of an ASP on the change in proportion of negative RADT given AB - 18m
The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed antibiotics (J01 excluding methenamine) for a sore throat where a rapid antigen detection test (RADT) to detect Group A Streptococcus (GAS) is taken and is negative being. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date.
The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
Measured: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months
The effect of an ASP on the change in proportion of recommended AB prescribed - 6m
The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed PcV compared to all patients prescribed any antibiotics (J01 excluding methenamine) for a sore throat. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date.
The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
Measured: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months
The effect of an ASP on the change in proportion of recommended AB prescribed - 12m
The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed PcV compared to all patients prescribed any antibiotics (J01 excluding methenamine) for a sore throat. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date.
The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
Measured: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months
The effect of an ASP on the change in proportion of recommended AB prescribed - 18m
The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed PcV compared to all patients prescribed any antibiotics (J01 excluding methenamine) for a sore throat. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date.
The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
Measured: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months
The effect of an ASP on the change in proportion of patients where CRP is requested - 6m
The effect of an antibiotic stewardship program (ASP) on the proportion of patients diagnosed with pharyngotonsillitis where the lab test C-reactive protein (CRP) is requested. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date.
The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
Measured: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months
The effect of an ASP on the change in proportion of patients where CRP is requested - 12m
The effect of an antibiotic stewardship program (ASP) on the proportion of patients diagnosed with pharyngotonsillitis where the lab test C-reactive protein (CRP) is requested. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date.
The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
Measured: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months
The effect of an ASP on the change in proportion of patients where CRP is requested - 18m
The effect of an antibiotic stewardship program (ASP) on the proportion of patients diagnosed with pharyngotonsillitis where the lab test C-reactive protein (CRP) is requested. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date.
The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
Measured: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months
Proportion of patients given AB for a sore throat with no throat swab taken
The proportion of patients given a diagnosis of pharyngotonsillitis and prescribed AB (J01 excluding methenamine) where a throat swab is not taken.
Descriptive statistics is presented and a group comparison is not made.
Measured: Pre intervention 6 Months period
Proportion of patients with pharyngotonsillitis where a throat swab is taken and sent for a culture
The proportion of patients given a diagnosis of pharyngotonsillitis and where a throat swab is taken and send to a microbiologic laboratory for a throat culture.
Descriptive statistics is presented and a group comparison is not made.
Measured: Pre intervention 6 Months period
Proportion of patients with pharyngotonsillitis where a test for mononucleosis is taken
The proportion of patients given a diagnosis of pharyngotonsillitis and where a test for mononucleosis is taken.
Descriptive statistics is presented and a group comparison is not made.
Measured: Pre intervention 6 Months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start17 Jan 2018
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group randomized controlled trial. Primary health care clinics are randomized. The enrolment number refers to included clinics.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- James Cook University, Queensland, Australia, Göteborg University
- Responsible party
- Sponsor
- Investigators
- Pär-Daniel Sundvall, MD PhD, Principal investigator, Vastra Gotaland region, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408704
- Sponsor's protocol ID
- U1111-1207-9573
- Acronym
- ASP-Throat
- Status last verified
- Feb 2022
- First submitted
- 17 Jan 2018
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be summary data for each participating primary health care clinic. The investigators will publish the summary of all clinics but don't intend to show data from single clinics.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Antimicrobial Stewardship Program (ASP) in Primary Health Care in the Management of Patients With a Sore Throat
- ClinicalTrials.gov ID
- NCT03408704
- Acronym / sponsor ID
- ASP-Throat / U1111-1207-9573
- Keywords
- Streptococcus Pyogenes Infection, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- James Cook University, Queensland, Australia, Göteborg University
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 24 Jan 2018 (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 have developed an antibiotic stewardship program (ASP) to increase adherence to the Swedish guidelines for managing patients with a sore throat. This is a randomized controlled trial where primary health care centers are randomised to get the ASP or not. The adherence to the Swedish guidelines are measured in all participating centers.
Detailed description
The investigators have developed an antibiotic stewardship program (ASP) to increase adherence to the Swedish guidelines for managing patients with a sore throat. This is a randomized controlled trial where primary health care centers are randomised to get the ASP or not. The adherence to the Swedish guidelines are measured in all participating centers 6 months before and after implementation of the ASP. The ASP consists of educational meetings at the clinic for medical practitioners and nurses being informed about current guidelines, seeing their clinics adherence to the guidelines as well as discussing cases.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group randomized controlled trial. Primary health care clinics are randomized. The enrolment number refers to included clinics.
| Arm | Type | Receives |
|---|---|---|
| ASP-arm | Experimental | Other: ASPThis group of primary health care centers get the internal education (ASP). |
| Control-arm | No intervention | –No intervention at all. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Being a primary health care center in the Vastra Gotaland region, Sweden accepting participation
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ASPIt consists of one educational session where doctors and staff at the center discuss current guidelines around management of patients attending for a sore throat. At the education the following is discussed: 1. The Swedish guidelines 2. Example of cases 3. Statistics from previous 6 month showing how well this clinic adheres to the Swedish guidelines. | Other | ASP-arm |
Primary outcome
The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 6m
Time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months
The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed antibiotics (J01 excluding methenamine) for a sore throat where a rapid antigen detection test (RADT) to detect Group A Streptococcus (GAS) is taken and is positive. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date. The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 12m
Time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months
The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed antibiotics (J01 excluding methenamine) for a sore throat where a rapid antigen detection test (RADT) to detect Group A Streptococcus (GAS) is taken and is positive. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date. The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 18m
Time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months
The effect of an antibiotic stewardship program (ASP) on the proportion of patients prescribed antibiotics (J01 excluding methenamine) for a sore throat where a rapid antigen detection test (RADT) to detect Group A Streptococcus (GAS) is taken and is positive. Change from a 6 month period before initiation of the intervention (baseline) is compared with a time period of 6 months prior to the follow up date. The change from baseline to follow-up in all primary health care centres (PHCC) in the intervention group is compared to the corresponding change in PHCC in the control group (ASP group versus control group) using linear regression where adjustment will also be made for: the number of enlisted patients at baseline, location in cities versus small villages, Adjusted Clinical Group (ACG), Care-need index (CNI) and type of PHCC (private/public).
12 secondary outcomes
The effect of an ASP on the change in proportion of negative RADT given AB - 6m
Time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months
The effect of an ASP on the change in proportion of negative RADT given AB - 12m
Time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months
The effect of an ASP on the change in proportion of negative RADT given AB - 18m
Time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months
The effect of an ASP on the change in proportion of recommended AB prescribed - 6m
Time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months
The effect of an ASP on the change in proportion of recommended AB prescribed - 12m
Time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months
The effect of an ASP on the change in proportion of recommended AB prescribed - 18m
Time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months
The effect of an ASP on the change in proportion of patients where CRP is requested - 6m
Time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months
The effect of an ASP on the change in proportion of patients where CRP is requested - 12m
Time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 12 months
The effect of an ASP on the change in proportion of patients where CRP is requested - 18m
Time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 18 months
Proportion of patients given AB for a sore throat with no throat swab taken
Time frame: Pre intervention 6 Months period
Proportion of patients with pharyngotonsillitis where a throat swab is taken and sent for a culture
Time frame: Pre intervention 6 Months period
Proportion of patients with pharyngotonsillitis where a test for mononucleosis is taken
Time frame: Pre intervention 6 Months period
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 6 Jun 2022.
- Individual participant dataSharing planned: No. The data will be summary data for each participating primary health care clinic. The investigators will publish the summary of all clinics but don't intend to show data from single clinics.
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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.
Pär-Daniel Sundvall, MD PhD principal investigator
Vastra Gotaland region, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASP in people with Tonsillitis and Streptococcus Pharyngitis, run by Vastra Gotaland Region at 1 site in Sweden.
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 6 Jun 2022. 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 Sweden. 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?
The effect of an ASP on the change in proportion of positive RADT among patients prescribed AB - 6m (time frame: Pre intervention 6 Months period compared to the 6 months period prior to follow-up at 6 months). The study lists 3 primary outcomes in all. 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 6 Jun 2022.