Group A Streptococcal InfectionSpyCATSNCT05117528
Streptococcus Pyogenes Carriage Acquisition and Transmission Study
An observational study of Group A Streptococcal Infection and Scabies, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
Group A Streptococcus (GAS) is a bacteria which causes severe infections and leads to deadly diseases such as rheumatic heart disease which kills over 300,000 people a year globally, particularly in low-income countries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Group A Streptococcal Infection, Scabies, Microbial Colonization
- How many people
- 441 participants
- Where
- 1 siteThe Gambia
- Study dates
- 27 Jul 2021to 30 Sep 2022
- Phase
- Observational
- 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
- Child, Adult, Older adult
Study population: Sukuta is an area within the West Coast Region peri-urban conurbation of The Gambia, with a population of 47,048 in 2013, including 7,234 children aged under 5 years, and an average household size of 8.1. The Gambia is the smallest mainland country in Africa with a population of 1.9 million in 2013 and was ranked 174th in the world in the UN Human Development Index in 2017. Households within the 2013 boundaries of Sukuta will be randomly selected using a list of randomly generated GPS locations stratified by housing density (high, medium and low). All eligible and willing households identified using the GPS location list will be enrolled, until the target sample size of 45 households is reached. All individuals living within the households will be enrolled, with no age restrictions.
Who may be able to join
- Households must:
- Be within the boundary of Sukuta as determined by the 2013 census
- Have at least 3 members including at least one child under age 18
- Individuals must:
- Provide signed (or thumbprinted) informed consent for study participation (obtained from a parent or guardian for children under the age of 18
- Be willing and have capacity to participate and comply with the study protocol as judged by a member of the study team
- Be resident in the household, with no plans to move outside of the household during the period of study participation
Who cannot join
- Households:
- Less than 80% of individuals living in the household, as defined by the The Gambia Demographic and Health Survey 2013 definition, provide consent to participate
- Individuals:
- Consent not provided
- Has any condition or any other reason that may lead to difficulty or discomfort in obtaining all the necessary samples
- Is judged by the study team member to be unable or unlikely to participate and comply with the study protocol for the entire study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Streptococcus Pyogenes Carriage Acquisition, Persistence and Transmission Dynamics Within Households in The Gambia: a Longitudinal Cohort Study
Group A Streptococcus (GAS) is a bacteria which causes severe infections and leads to deadly diseases such as rheumatic heart disease which kills over 300,000 people a year globally, particularly in low-income countries. It is not know how GAS is spread between people, how often people carry GAS in their throat or on their skin without having symptoms, or what factors increase the chance of this occurring. It is important to understand these factors in order to know how to reduce GAS-related disease.
This study will follow 444 people in The Gambia, over 12 months, taking samples from the throats and skin of people living in the same households, and asking questions about themselves and their behaviour, at regular intervals. By taking samples over time, the investigators hope to understand how common it is to carry GAS without having symptoms, how GAS is spread between people, and whether carrying GAS leads to more GAS infections in people or their household members.
The study will use state-of-the-art techniques to look at the DNA of GAS bacteria that we find, and combine this with a mathematical model to investigate how different strains spread to people within and between households in the community.
Read the detailed description
Type of study and design
The study is a prospective, longitudinal (open) cohort study within households in Sukuta, The Gambia. Households will be recruited, and all available household members asked to participate. Households will be followed for 12 months, with up to monthly visits (at least 3-monthly visits), and more frequently for some subgroups of participants.
A total of 45 households will be recruited, including every available household member as individual participants (resulting in a cohort of approximately 450 participant with the average household size in Sukuta being around 10).
Households will be enrolled for 12 months, with enrolment aiming to commence before the rainy season, to ensure that the enrolment period will span one full rainy season, with dry periods either side. Every household will undergo an enrolment visit (MV0), then up to monthly visits (MV1, MV2, MV3 etc., up to MV12) or less frequently if practical constraints arise.
At each visit an oropharyngeal swab, normal skin swab, oral fluid sample and dried blood spot sample will be taken from all individuals, data collected on socio-demographics, social mixing behaviour and clinical examination findings. Examination findings recorded will include evidence of pharyngitis, pyoderma, and scabies. In addition, a blood sample for serum will be taken at the beginning and end of the study for detailed functional immune responses. Swabs will also be taken from any pyoderma lesions, from common touch points in the household such as door handles, and settle plates used inside households.
Swabs will be transported the same day to the laboratory and plated for microbiological culture. The culture will identify the presence of GAS from the swabs, and if present, antibiotic resistance will be determined and isolates stored for later use. Additionally, if Groups C and G Streptococcus are identified the isolates will be stored, and from normal skin and pyoderma wound swabs, any Staphylococcus aureus isolates will stored.
Swabs from participants will be cultured for the presence of GAS and isolates will undergo whole genome sequencing in order to assess phylogenetic relatedness of strains identified. These data, combined with temporal incidence of strain acquisition, clinical data and household situation will be used to build a mathematical model of GAS transmission to identify key routes of transmission within and between households.
Sub-studies:
Intensified incident GAS surveillance cohort
A subgroup of 12 households, most with at least one asymptomatic GAS carrying individual at baseline, and some with no carriers, will form a cohort to undergo intensified swabbing. This cohort will be used to assess incidence of GAS carriage and disease with greater resolution than the main cohort. All household members present will undergo more frequent swabbing, with a view to being visited every week for 6 months. At these visits, more detailed social-mixing behaviour data will be collected.
Estimating duration of GAS carriage
A further subgroup will also be identified to allow for greater resolution in the estimation of the duration of GAS carriage. Following enrolment, any participant who becomes GAS carrier positive (i.e. was negative at baseline or the previous visit, and then becomes positive asymptomatically) will have weekly swabs taken from the same site that was positive, until 2 GAS negative swabs have been taken in a row.
Estimating GAS infection incidence
To assess incidence of clinical GAS disease in the cohort throughout the study, all participants reporting symptoms suggestive of possible clinical GAS infection such as pharyngitis or pyoderma (but also including invasive infections), will be visited for an unscheduled visit where a clinical and health-seeking history will be recorded, a swab, saliva and DBS taken, and treatment (or further management) will be delivered according to WHO guidelines or best local practice. Furthermore, at each scheduled visit, any individual identified with symptoms of clinical GAS infection will undergo the same process of history-taking, swabbing, treatment and follow up.
- Keywords
- Group A Streptococcal skin colonization, Group A Streptococcal pharyngeal carriage, Group A Streptococcal transmission
- Medical subject headings
- Streptococcal Infections, Scabies, Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of oropharyngeal swabs positive for GAS each month
Oropharyngeal swabs taken at monthly visits will be plated for microbiological culture, and the presence of GAS determined by latex agglutination testing.
Measured: Monthly visits
Prevalence of normal skin swabs positive for GAS each month
Normal skin swabs taken at monthly visits will be plated for microbiological culture, and the presence of GAS determined by latex agglutination testing.
Measured: Monthly visits
Incidence of GAS-positive oropharyngeal swabs
Oropharyngeal swabs taken at each visit will be plated for microbiological culture, and the presence of GAS determined by latex agglutination testing. The incidence of positive swabs in person-years will be calculated
Measured: 1 year
Incidence of GAS-positive normal skin swabs
Normal skin swabs taken at each visit will be plated for microbiological culture, and the presence of GAS determined by latex agglutination testing. The incidence of positive swabs in person-years will be calculated
Measured: 1 year
Change in GAS-positive swabs per month
Seasonal changes in GAS-positivity will be assessed over the course of a year.
Measured: 1 year
Secondary outcomes (11)
Adjusted hazard ratio for GAS carriage depending on presence of relevant risk factors
Measured: 1 year
Adjusted hazard ratio for GAS symptomatic infection depending on presence of relevant risk factors
Measured: 1 year
Difference in GAS emm type diversity compared to other settings
Measured: 1 year
The level of GAS tissue tropism
Measured: 1 year
Prevalence of Group C streptococcal carriage
Measured: Monthly
Prevalence of Group G streptococcal carriage
Measured: Monthly
Prevalence of Staphylococcus aureus skin carriage
Measured: Monthly
Seroprevalence of anti-GAS antibodies
Measured: Baseline
Sensitivity of GAS isolates to antimicrobials.
Measured: 1 year
Difference in GAS-specific serological immune activity between GAS-colonised and non-GAS colonised participants
Measured: 1 year
Difference in GAS-specific mucosal immune activity between GAS-colonised and non-GAS colonised participants
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start27 Jul 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Group A Streptococcal InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Edwin P Armitage, BMBS, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117528
- Sponsor's protocol ID
- LEO 24005
- Acronym
- SpyCATS
- Status last verified
- Nov 2022
- First submitted
- 21 Apr 2021
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised raw data for all analysis performed during manuscript preparation will be published alongside the manuscripts. All other data will be archived at the MRC Unit The Gambia and will be made available to other researchers upon reasonable request.
Publications
de Crombrugghe G, Armitage EP, Keeley AJ, Senghore E, Camara F, Jammeh M, Bittaye A, Ceesay H, Ceesay I, Samateh B, Manneh M, Botquin G, Lakhloufi D, Delforge V, Bah SY, Hall JN, Schiavolin L, Turner CE, Marks M, de Silva TI, Botteaux A, Smeesters PR; MRCG StrepA Study Group. Household Molecular Epidemiology of Streptococcus pyogenes Carriage and Infection in The Gambia. J Infect Dis. 2025 Sep 15;232(3):550-559. doi: 10.1093/infdis/jiaf252.
PubMed 40378280Armitage EP, de Crombrugghe G, Keeley AJ, Senghore E, Camara FE, Jammeh M, Bittaye A, Ceesay H, Ceesay I, Samateh B, Manneh M, Kampmann B, Turner CE, Kucharski A, Botteaux A, Smeesters PR, de Silva TI, Marks M; MRCG StrepA Study Group. Streptococcus pyogenes carriage and infection within households in The Gambia: a longitudinal cohort study. Lancet Microbe. 2024 Jul;5(7):679-688. doi: 10.1016/S2666-5247(24)00046-6. Epub 2024 May 9.
PubMed 38735305
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streptococcus Pyogenes Carriage Acquisition, Persistence and Transmission Dynamics Within Households in The Gambia: a Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT05117528
- Acronym / sponsor ID
- SpyCATS / LEO 24005
- Keywords
- Group A Streptococcal skin colonization, Group A Streptococcal pharyngeal carriage, Group A Streptococcal transmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 11 Nov 2021 (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.
Group A Streptococcus (GAS) is a bacteria which causes severe infections and leads to deadly diseases such as rheumatic heart disease which kills over 300,000 people a year globally, particularly in low-income countries. It is not know how GAS is spread between people, how often people carry GAS in their throat or on their skin without having symptoms, or what factors increase the chance of this occurring. It is important to understand these factors in order to know how to reduce GAS-related disease.
This study will follow 444 people in The Gambia, over 12 months, taking samples from the throats and skin of people living in the same households, and asking questions about themselves and their behaviour, at regular intervals. By taking samples over time, the investigators hope to understand how common it is to carry GAS without having symptoms, how GAS is spread between people, and whether carrying GAS leads to more GAS infections in people or their household members.
The study will use state-of-the-art techniques to look at the DNA of GAS bacteria that we find, and combine this with a mathematical model to investigate how different strains spread to people within and between households in the community.
Detailed description
Type of study and design
The study is a prospective, longitudinal (open) cohort study within households in Sukuta, The Gambia. Households will be recruited, and all available household members asked to participate. Households will be followed for 12 months, with up to monthly visits (at least 3-monthly visits), and more frequently for some subgroups of participants.
A total of 45 households will be recruited, including every available household member as individual participants (resulting in a cohort of approximately 450 participant with the average household size in Sukuta being around 10).
Households will be enrolled for 12 months, with enrolment aiming to commence before the rainy season, to ensure that the enrolment period will span one full rainy season, with dry periods either side. Every household will undergo an enrolment visit (MV0), then up to monthly visits (MV1, MV2, MV3 etc., up to MV12) or less frequently if practical constraints arise.
At each visit an oropharyngeal swab, normal skin swab, oral fluid sample and dried blood spot sample will be taken from all individuals, data collected on socio-demographics, social mixing behaviour and clinical examination findings. Examination findings recorded will include evidence of pharyngitis, pyoderma, and scabies. In addition, a blood sample for serum will be taken at the beginning and end of the study for detailed functional immune responses. Swabs will also be taken from any pyoderma lesions, from common touch points in the household such as door handles, and settle plates used inside households.
Swabs will be transported the same day to the laboratory and plated for microbiological culture. The culture will identify the presence of GAS from the swabs, and if present, antibiotic resistance will be determined and isolates stored for later use. Additionally, if Groups C and G Streptococcus are identified the isolates will be stored, and from normal skin and pyoderma wound swabs, any Staphylococcus aureus isolates will stored.
Swabs from participants will be cultured for the presence of GAS and isolates will undergo whole genome sequencing in order to assess phylogenetic relatedness of strains identified. These data, combined with temporal incidence of strain acquisition, clinical data and household situation will be used to build a mathematical model of GAS transmission to identify key routes of transmission within and between households.
Sub-studies:
Intensified incident GAS surveillance cohort
A subgroup of 12 households, most with at least one asymptomatic GAS carrying individual at baseline, and some with no carriers, will form a cohort to undergo intensified swabbing. This cohort will be used to assess incidence of GAS carriage and disease with greater resolution than the main cohort. All household members present will undergo more frequent swabbing, with a view to being visited every week for 6 months. At these visits, more detailed social-mixing behaviour data will be collected.
Estimating duration of GAS carriage
A further subgroup will also be identified to allow for greater resolution in the estimation of the duration of GAS carriage. Following enrolment, any participant who becomes GAS carrier positive (i.e. was negative at baseline or the previous visit, and then becomes positive asymptomatically) will have weekly swabs taken from the same site that was positive, until 2 GAS negative swabs have been taken in a row.
Estimating GAS infection incidence
To assess incidence of clinical GAS disease in the cohort throughout the study, all participants reporting symptoms suggestive of possible clinical GAS infection such as pharyngitis or pyoderma (but also including invasive infections), will be visited for an unscheduled visit where a clinical and health-seeking history will be recorded, a swab, saliva and DBS taken, and treatment (or further management) will be delivered according to WHO guidelines or best local practice. Furthermore, at each scheduled visit, any individual identified with symptoms of clinical GAS infection will undergo the same process of history-taking, swabbing, treatment and follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Sukuta is an area within the West Coast Region peri-urban conurbation of The Gambia, with a population of 47,048 in 2013, including 7,234 children aged under 5 years, and an average household size of 8.1. The Gambia is the smallest mainland country in Africa with a population of 1.9 million in 2013 and was ranked 174th in the world in the UN Human Development Index in 2017. Households within the 2013 boundaries of Sukuta will be randomly selected using a list of randomly generated GPS locations stratified by housing density (high, medium and low). All eligible and willing households identified using the GPS location list will be enrolled, until the target sample size of 45 households is reached. All individuals living within the households will be enrolled, with no age restrictions.
Key inclusion criteria (7 listed)
- Be within the boundary of Sukuta as determined by the 2013 census
- Have at least 3 members including at least one child under age 18
- Provide signed (or thumbprinted) informed consent for study participation (obtained from a parent or guardian for children under the age of 18
- Be willing and have capacity to participate and comply with the study protocol as judged by a member of the study team
- Be resident in the household, with no plans to move outside of the household during the period of study participation
Key exclusion criteria (6 listed)
- Less than 80% of individuals living in the household, as defined by the The Gambia Demographic and Health Survey 2013 definition, provide consent to participate
- Consent not provided
- Has any condition or any other reason that may lead to difficulty or discomfort in obtaining all the necessary samples
- Is judged by the study team member to be unable or unlikely to participate and comply with the study protocol for the entire study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of oropharyngeal swabs positive for GAS each month
Time frame: Monthly visits
Oropharyngeal swabs taken at monthly visits will be plated for microbiological culture, and the presence of GAS determined by latex agglutination testing.
Prevalence of normal skin swabs positive for GAS each month
Time frame: Monthly visits
Normal skin swabs taken at monthly visits will be plated for microbiological culture, and the presence of GAS determined by latex agglutination testing.
Incidence of GAS-positive oropharyngeal swabs
Time frame: 1 year
Oropharyngeal swabs taken at each visit will be plated for microbiological culture, and the presence of GAS determined by latex agglutination testing. The incidence of positive swabs in person-years will be calculated
Incidence of GAS-positive normal skin swabs
Time frame: 1 year
Normal skin swabs taken at each visit will be plated for microbiological culture, and the presence of GAS determined by latex agglutination testing. The incidence of positive swabs in person-years will be calculated
Change in GAS-positive swabs per month
Time frame: 1 year
Seasonal changes in GAS-positivity will be assessed over the course of a year.
11 secondary outcomes
Adjusted hazard ratio for GAS carriage depending on presence of relevant risk factors
Time frame: 1 year
Adjusted hazard ratio for GAS symptomatic infection depending on presence of relevant risk factors
Time frame: 1 year
Difference in GAS emm type diversity compared to other settings
Time frame: 1 year
The level of GAS tissue tropism
Time frame: 1 year
Prevalence of Group C streptococcal carriage
Time frame: Monthly
Prevalence of Group G streptococcal carriage
Time frame: Monthly
Prevalence of Staphylococcus aureus skin carriage
Time frame: Monthly
Seroprevalence of anti-GAS antibodies
Time frame: Baseline
Sensitivity of GAS isolates to antimicrobials.
Time frame: 1 year
Difference in GAS-specific serological immune activity between GAS-colonised and non-GAS colonised participants
Time frame: 1 year
Difference in GAS-specific mucosal immune activity between GAS-colonised and non-GAS colonised participants
Time frame: 1 year
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 25 Nov 2022.
- Derived from this study: PubMed 40378280de Crombrugghe G, Armitage EP, Keeley AJ, Senghore E, Camara F, Jammeh M, Bittaye A, Ceesay H, Ceesay I, Samateh B, Manneh M, Botquin G, Lakhloufi D, Delforge V, Bah SY, Hall JN, Schiavolin L, Turner CE, Marks M, de Silva TI, Botteaux A, Smeesters PR; MRCG StrepA Study Group. Household Molecular Epidemiology of Streptococcus pyogenes Carriage and Infection in The Gambia. J Infect Dis. 2025 Sep 15;232(3):550-559. doi: 10.1093/infdis/jiaf252.
- Derived from this study: PubMed 38735305Armitage EP, de Crombrugghe G, Keeley AJ, Senghore E, Camara FE, Jammeh M, Bittaye A, Ceesay H, Ceesay I, Samateh B, Manneh M, Kampmann B, Turner CE, Kucharski A, Botteaux A, Smeesters PR, de Silva TI, Marks M; MRCG StrepA Study Group. Streptococcus pyogenes carriage and infection within households in The Gambia: a longitudinal cohort study. Lancet Microbe. 2024 Jul;5(7):679-688. doi: 10.1016/S2666-5247(24)00046-6. Epub 2024 May 9.
- Individual participant dataSharing planned: Yes. Anonymised raw data for all analysis performed during manuscript preparation will be published alongside the manuscripts. All other data will be archived at the MRC Unit The Gambia and will be made available to other researchers upon reasonable request.
Related trials for Group A Streptococcal Infection
Not yet recruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruitingPhase 1
Stopping Strep Throat With Antibodies in Healthy Adults.
Streptococcal Pharyngitis
RecruitingPhase 3
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Pneumococcal Immunization, Healthy Volunteers
Not yet recruitingPhase 4
Short Versus Standard Amoxicillin for Pediatric Strep Throat
Group A Streptococcal (GAS) Pharyngitis
Active, not recruiting
Evaluation of Efficacy of Antibacterial Activity of Licorice, Clove, and Chlorohexidine Mouthwashes on Salivary Streptococcus Mutans in a Group of Egyptian Children.
Dental Caries, Streptococcal 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.
Edwin P Armitage, BMBS principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group A Streptococcal Infection and Scabies, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
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 7 inclusion and 6 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 25 Nov 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 The Gambia. 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?
Prevalence of oropharyngeal swabs positive for GAS each month (time frame: Monthly visits). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05117528, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.