SinusitisPhase 3NCT02554383
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
A Phase 3 study testing Amoxicillin-clavulanate in people with Sinusitis and Respiratory Tract Infections, run by Nader Shaikh at 6 sites in United States.
Trial summary
The objective of this trial is to determine whether certain subgroups of children with acute sinusitis exist in whom antibiotic therapy can be appropriately withheld. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Sinusitis, Respiratory Tract Infections
- What is being tested?
- Amoxicillin-clavulanate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 515 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2016to 9 Mar 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets criteria for "persistent" or "worsening" presentations of sinusitis
- Baseline score ≥9 on the Pediatric Rhinosinusitis Symptom Scale
Who cannot join
- Severe presentation (≥3 days of colored nasal discharge and fever ≥39°C
- Asthma/allergic rhinitis explains symptoms
- Allergy to amoxicillin-clavulanate
- Immotile cilia syndrome
- Cystic fibrosis
- Immunodeficiency
Show all 11Show fewer
- Parental inability to read/write English or Spanish
- Other concurrent infection (e.g., pneumonia, acute otitis media, streptococcal pharyngitis)
- Systemic toxicity
- Wheezing on exam
- Antibiotic use within 15 days
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
Cyn3rgy Research
Gresham, Oregon, 97030
American Family Children's Hospital
Madison, Wisconsin, 53792
WVU Medicine Pediatric and Adolescent Group Practice
Morgantown, West Virginia, 26501
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
The objective of this trial is to determine whether certain subgroups of children with acute sinusitis exist in whom antibiotic therapy can be appropriately withheld.
Read the detailed description
The current clinical practice guideline from the American Academy of Pediatrics for the Diagnosis and Management of Acute Bacterial Sinusitis recommends that the diagnosis of acute sinusitis is made when symptoms of an upper respiratory infection (URI) persist beyond 10 days without showing signs of improvement (persistent presentation), when symptoms appear to worsen (on the 6th to 10th day) after a period of improvement (worsening presentation), or when both high fever and purulent nasal discharge are present concurrently for at least 3 consecutive days (severe presentation). In studies to date, children with persistent and worsening presentations comprise >95% of cases. The investigators preliminary data and the available literature suggest that only a subset of children being diagnosed with acute sinusitis on the basis of current criteria are likely to have bacterial disease. This is not entirely surprising because current criteria rely solely on the duration and the quality of respiratory tract symptoms (which are both common and non-specific). Accordingly, it seems likely that many children currently being diagnosed as having acute sinusitis actually have an uncomplicated upper respiratory infection. This is important because acute sinusitis is one of the most common diagnoses for which antimicrobials are prescribed for children in the United States, accounting for 7.9 million prescriptions annually. A critical need thus exists to establish which subgroups of children currently being diagnosed with acute sinusitis actually benefit from antimicrobial therapy.
The objective of this trial is to determine whether certain subgroups of children with acute sinusitis exist in whom antibiotic therapy can be appropriately withheld. This objective will be achieved by conducting a large, randomized, double-blind, placebo-controlled clinical trial in children 2 to 12 years of age with persistent or worsening presentations of acute sinusitis. Based on the investigators preliminary data, the investigators hypothesize that only certain subgroups of children currently being treated for acute sinusitis actually benefit from antimicrobial therapy. By identifying, in a large placebo-controlled trial, subgroups of children who respectively do and do not benefit from antimicrobial therapy, the investigators will be better able to determine which children should be classified as having acute bacterial sinusitis. Accordingly, the results of this trial may impact not only the treatment guidelines for acute sinusitis but also the diagnostic criteria, and will help ensure that, to the extent possible, antibiotic use is limited to appropriate patients. This, in turn, will maximize the likelihood of achieving optimal outcomes and minimize the risk of promoting antibiotic resistance.
- Conditions
- Sinusitis, Respiratory Tract Infections
- Being tested
- Amoxicillin-clavulanate, Placebo
- Keywords
- pediatrics, antibiotics, placebo
- Medical subject headings
- Sinusitis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-clavulanateDrug
Also called Augmentin-Extra strength
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
PlaceboDrug
placebo made to match the study antibiotic given twice a day orally for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days) Receives: Drug: Amoxicillin-clavulanate |
| Treatment B | Placebo comparator | Placebo made to match the study antibiotic will be taken bid orally for 10 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) \& electronically on diaries evenings Days 2-11. Pathogens cultured were Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.
Measured: Days 2 to 11
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) \& electronically on diaries evenings Days 2-11. Nasal discharge, either yellow or green, was considered colored.
Measured: Days 2 to 11
Secondary outcomes (5)
The Distribution of Children Experiencing Treatment Failure (TF)
The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment), electronically evenings Days 2-11 \& at the follow-up visit. If, compared to the Day 1 score, there was >20% increase at any time, decrease <2 on Day 3, <20% decrease on Day 4, <20% decrease on 2 consecutive occasions Days 5-11 or <50% decrease at follow-up, then criterion for treatment failure (TF) was met. Multiple imputation was used when data was insufficient to assess TF.
Measured: Day of enrollment to the day of the follow-up visit. The mean length of actual follow-up was 13.4 days. For each child with incomplete follow-up, multiple imputation was used and PRSS scores for the remaining days were imputed.
The Distribution of Children Developing Acute Otitis Media (AOM) Over the First 10 Days of Follow-up
AOM is an infection of the middle ear marked by acute symptoms and a bulging tympanic membrane. Its diagnosis coincided with receipt of a systemic antibiotic. Systemic antibiotics include Amoxicillin, Amoxicillin-clavulanate, Azithromycin, Bacillin L-A, Cefdinir, Clindamycin, Doxycycline, Levofloxacin, Ofloxacin \& Sulfamethoxazole-Trimethoprim. Start and stop dates were recorded.
Measured: Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8.
The Distribution of Children Receiving a Systemic Antibiotic Over the First 10 Days of Follow-up
Systemic antibiotics include Amoxicillin, Amoxicillin-clavulanate, Azithromycin, Bacillin L-A, Cefdinir, Clindamycin, Doxycycline, Levofloxacin, Ofloxacin \& Sulfamethoxazole-Trimethoprim. Start and stop dates were recorded. The antibiotic received is exclusive of the study product assigned at enrollment.
Measured: Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8.
The Distribution of Children for Whom Diarrhea or Generalized Rash Was Reported
The monitoring of adverse events (AEs), i.e. diarrhea or generalized rash, began on Day 1 (enrollment) and continued through Day 23 (the follow-up visit). Diarrhea was the occurrence of 3 or more watery stools on one day or 2 watery stools on each of 2 consecutive days. Parents recorded in daily diaries, Days 1-11, information regarding the occurrence of diarrhea. Additionally, parents were asked at the follow-up visit if their child had diarrhea while on study product.
Measured: Day 1 through Day 23.
The Distribution of Children Compliant With Study Medication
Compliance, expressed as a percentage, is the total number of doses taken divided by the total number of expected doses. The child is considered compliant if he/she has received at least 70% of the study medication. The parent completed diaries evenings Days 2-11. The diaries included yes/no questions - (1) did your child take the study medication last night and (2) did your child take the study medication this morning? The total number of doses taken was calculated based on the responses to question (1), and accounted for the dose dispensed at enrollment when enrollment was 1pm or earlier on Day 1. The total of expected doses was determined from the responses to questions (1) and (2), and accounted for scenarios in which the child was taken off the study medication by the clinician. In some cases, due to incomplete diaries the information was insufficient to declare a child either compliant or not compliant.
Measured: Days 1 to 11, where Day 1 is day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startFeb 2016
- Primary completion31 Mar 2022
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nader Shaikh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nader Shaikh, University of Pittsburgh
- Investigators
- Nader Shaikh, MPH, MD, Principal investigator, University of PittsburghEllen R Wald, MD, Principal investigator, University of Wisconsin, American Family Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554383
- Sponsor's protocol ID
- STUDY20110386
- Other IDs
- U01AI118506
- Status last verified
- Jun 2023
- First submitted
- 8 Sep 2015
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Shaikh N, Hoberman A, Shope TR, Jeong JH, Kurs-Lasky M, Martin JM, Bhatnagar S, Muniz GB, Block SL, Andrasko M, Lee MC, Rajakumar K, Wald ER. Identifying Children Likely to Benefit From Antibiotics for Acute Sinusitis: A Randomized Clinical Trial. JAMA. 2023 Jul 25;330(4):349-358. doi: 10.1001/jama.2023.10854.
PubMed 37490085
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
- ClinicalTrials.gov ID
- NCT02554383
- Acronym / sponsor ID
- STUDY20110386
- Conditions
- Sinusitis, Respiratory Tract Infections
- Keywords
- pediatrics, antibiotics, placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Nader ShaikhUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Feb 2016 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Posted 8 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to determine whether certain subgroups of children with acute sinusitis exist in whom antibiotic therapy can be appropriately withheld.
Detailed description
The current clinical practice guideline from the American Academy of Pediatrics for the Diagnosis and Management of Acute Bacterial Sinusitis recommends that the diagnosis of acute sinusitis is made when symptoms of an upper respiratory infection (URI) persist beyond 10 days without showing signs of improvement (persistent presentation), when symptoms appear to worsen (on the 6th to 10th day) after a period of improvement (worsening presentation), or when both high fever and purulent nasal discharge are present concurrently for at least 3 consecutive days (severe presentation). In studies to date, children with persistent and worsening presentations comprise >95% of cases. The investigators preliminary data and the available literature suggest that only a subset of children being diagnosed with acute sinusitis on the basis of current criteria are likely to have bacterial disease. This is not entirely surprising because current criteria rely solely on the duration and the quality of respiratory tract symptoms (which are both common and non-specific). Accordingly, it seems likely that many children currently being diagnosed as having acute sinusitis actually have an uncomplicated upper respiratory infection. This is important because acute sinusitis is one of the most common diagnoses for which antimicrobials are prescribed for children in the United States, accounting for 7.9 million prescriptions annually. A critical need thus exists to establish which subgroups of children currently being diagnosed with acute sinusitis actually benefit from antimicrobial therapy.
The objective of this trial is to determine whether certain subgroups of children with acute sinusitis exist in whom antibiotic therapy can be appropriately withheld. This objective will be achieved by conducting a large, randomized, double-blind, placebo-controlled clinical trial in children 2 to 12 years of age with persistent or worsening presentations of acute sinusitis. Based on the investigators preliminary data, the investigators hypothesize that only certain subgroups of children currently being treated for acute sinusitis actually benefit from antimicrobial therapy. By identifying, in a large placebo-controlled trial, subgroups of children who respectively do and do not benefit from antimicrobial therapy, the investigators will be better able to determine which children should be classified as having acute bacterial sinusitis. Accordingly, the results of this trial may impact not only the treatment guidelines for acute sinusitis but also the diagnostic criteria, and will help ensure that, to the extent possible, antibiotic use is limited to appropriate patients. This, in turn, will maximize the likelihood of achieving optimal outcomes and minimize the risk of promoting antibiotic resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: Amoxicillin-clavulanateAmoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days) |
| Treatment B | Placebo comparator | Drug: PlaceboPlacebo made to match the study antibiotic will be taken bid orally for 10 days |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Meets criteria for "persistent" or "worsening" presentations of sinusitis
- Baseline score ≥9 on the Pediatric Rhinosinusitis Symptom Scale
Key exclusion criteria (11 listed)
- Severe presentation (≥3 days of colored nasal discharge and fever ≥39°C
- Asthma/allergic rhinitis explains symptoms
- Allergy to amoxicillin-clavulanate
- Immotile cilia syndrome
- Cystic fibrosis
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 |
|---|---|---|
| Amoxicillin-clavulanateAlso: Augmentin-Extra strengthAmoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days) | Drug | Treatment A |
| Placeboplacebo made to match the study antibiotic given twice a day orally for 10 days | Drug | Treatment B |
Primary outcome
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Time frame: Days 2 to 11
The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) \& electronically on diaries evenings Days 2-11. Pathogens cultured were Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
Time frame: Days 2 to 11
The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) \& electronically on diaries evenings Days 2-11. Nasal discharge, either yellow or green, was considered colored.
5 secondary outcomes
The Distribution of Children Experiencing Treatment Failure (TF)
Time frame: Day of enrollment to the day of the follow-up visit. The mean length of actual follow-up was 13.4 days. For each child with incomplete follow-up, multiple imputation was used and PRSS scores for the remaining days were imputed.
The Distribution of Children Developing Acute Otitis Media (AOM) Over the First 10 Days of Follow-up
Time frame: Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8.
The Distribution of Children Receiving a Systemic Antibiotic Over the First 10 Days of Follow-up
Time frame: Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8.
The Distribution of Children for Whom Diarrhea or Generalized Rash Was Reported
Time frame: Day 1 through Day 23.
The Distribution of Children Compliant With Study Medication
Time frame: Days 1 to 11, where Day 1 is day of enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37490085Shaikh N, Hoberman A, Shope TR, Jeong JH, Kurs-Lasky M, Martin JM, Bhatnagar S, Muniz GB, Block SL, Andrasko M, Lee MC, Rajakumar K, Wald ER. Identifying Children Likely to Benefit From Antibiotics for Acute Sinusitis: A Randomized Clinical Trial. JAMA. 2023 Jul 25;330(4):349-358. doi: 10.1001/jama.2023.10854.
- Individual participant dataSharing planned: Yes
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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.
Nader Shaikh, MPH, MD principal investigator
University of Pittsburgh
Ellen R Wald, MD principal investigator
University of Wisconsin, American Family Children's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amoxicillin-clavulanate in people with Sinusitis and Respiratory Tract Infections, run by Nader Shaikh at 6 sites in United States.
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 11 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment (time frame: Days 2 to 11). The study lists 2 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 NCT02554383, which also lists 1 linked publication.
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 29 Jun 2023.