Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001310550
Ethics application status
Approved
Date submitted
10/10/2024
Date registered
29/10/2024
Date last updated
29/10/2024
Date data sharing statement initially provided
29/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Tonsil and Respiratory Tract Infections with Strep A and Epstein-Barr Virus (EBV)
Scientific title
TORTOISE - a study of the succeptibility of epithelial and lymphoid cells to tonsillar pathogens
Secondary ID [1] 313154 0
NONE
Universal Trial Number (UTN)
Trial acronym
TORTOISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Tonsillitis 335426 0
Condition category
Condition code
Inflammatory and Immune System 331984 331984 0 0
Normal development and function of the immune system
Infection 331985 331985 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a study to collect tonsillar samples that would be otherwise routinely discarded during tonsillectomy surgery to establish a laboratory system to investigate individual susceptibility to tonsillar pathogens through the interactions of these pathogens with tonsil epithelium and lymphoid organoids.

Demographic information on patients will be collected preoperatively. Parents of patients will be asked to complete a questionnaire which will address common questions about the child’s health, in particular their tonsilitis / sore throat history, respiratory symptoms and anaesthesia respiratory risk factors. This questionnaire will be administered by the research team member and will take no longer than 10 minutes. Participant saliva samples will be collected prior to the child being anaesthetised for surgery. If the child is unwilling or not cooperative this will be completed during surgery. Once anaesthetised, a pharyngeal swab and blood will be collected. Following the surgical removal of the tonsils, the surgeon will place them in sample pots with media for collection by study staff. Tonsillectomy surgery typically takes around 45 minutes, but varies widely depending on the surgeon and the clinical condition of the patient. Participants will not experience any changes to their surgical procedure as part of their participation in this study. Any incidence of respiratory adverse events intraoperatively or post-operatively will be recorded by the treating clinician. No patient follow up is done after the patient has left the post-anaesthetic care unit.

Samples will be used to:
1. Establish an epithelial model of strep A infection
2. Establish a lymphoid organoid model of strep A infection
3. Compare tonsil lymphoid cell repetoires from individuals with different disease states
4. Analyse immunohistochemistry of tonsil tissues
5. Isolate strep A from pharyngeal tonsil swabs
6. Experimentally inhibit strep A attachement by salivary antibodies
7. Clone human antibody variable domains from participants with protective salivary antibodies
8. Identify intracellular strep A infections in participants with recurrent tonsillitis
9. Examine individual succeptibility to intracellular strep A infections
10. Compare peripheral blood mononuclear cell repertoires from individuals with different tonsillar disease states and correlate or compare to matching tonsil cell repertoires
Intervention code [1] 329728 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339598 0
Successful collection of tonsil samples from children undergoing tonsillectomy
Timepoint [1] 339598 0
At the end of study recruitment period.
Primary outcome [2] 339603 0
Successful collection of blood samples from children undergoing tonsillectomy
Timepoint [2] 339603 0
At the end of study recruitment period.
Primary outcome [3] 339604 0
Successful collection of saliva samples from children undergoing tonsillectomy
Timepoint [3] 339604 0
At the end of study recruitment period.
Secondary outcome [1] 440547 0
[Primary outcome 4] Successful collection of pharyngeal swab samples from children undergoing tonsillectomy
Timepoint [1] 440547 0
[Primary outcome 4] At the end of study recruitment period.
Secondary outcome [2] 440563 0
Assess the incidence of perioperative respiratory adverse events (PRAE) in paediatric patients undergoing general anaesthesia. PRAE are defined as: o Laryngospasm: complete airway obstruction with associated muscle rigidity of the abdominal and chest walls. o Bronchospasm: increased respiratory effort, particularly during expiration and wheeze on auscultation. o Desaturation: Oxygen saturation < 95% for >10secs on pulse oximetry o Airway obstruction: the presence of airway obstruction with a snoring noise and/or increased respiratory efforts. o Severe persistent coughing: pronounced, persistent coughs lasting more than 10 seconds. o Post-operative stridor: high pitched sound during breathing in the postoperative period.
Timepoint [2] 440563 0
PRAE will be assessed at induction, maintenance, emergence, peri-extubation and recovery from anaesthesia.

Eligibility
Key inclusion criteria
1. Aged from 0 to 16.99 years old.
2. Undergoing surgery for tonsillectomy (+/-adenoidectomy) and tonsillotomies.
3. Parent/legal guardian has given written informed consent, or where appropriate child assent.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Insufficient English language such that informed consent is not possible.
2. Department for Child Protection and Family Services involvement in patient care.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
As this is an early phase study that is designed to collect information on effect size and variability, with 25 samples per group, we will be able to detect an increase of at least 0.8 standard deviations in mean percentage adherence of Strep A to primary tonsil epithelial cells between the recurrent tonsillitis and non-recurrent tonsillitis (e.g. OSA) groups. This was estimated using “G*Power v.3.1.9.7” and is based on 80% power, a two-sided Student t-test for independent groups and a 5% significance level.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27206 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 43290 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 317596 0
Government body
Name [1] 317596 0
Perth Children's Hospital
Country [1] 317596 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Kids Institute
Address
Country
Australia
Secondary sponsor category [1] 319914 0
None
Name [1] 319914 0
Address [1] 319914 0
Country [1] 319914 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316301 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 316301 0
Ethics committee country [1] 316301 0
Australia
Date submitted for ethics approval [1] 316301 0
26/02/2024
Approval date [1] 316301 0
25/03/2024
Ethics approval number [1] 316301 0
RGS0000006553

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137450 0
Prof Shyan Vijayasekaran
Address 137450 0
Perth Children's Hospital 15 Hospital Avenue Nedlands WA 6009
Country 137450 0
Australia
Phone 137450 0
+61402040240
Fax 137450 0
Email 137450 0
[email protected]
Contact person for public queries
Name 137451 0
Britta Regli-von Ungern Sternberg
Address 137451 0
Perth Children's Hospital 15 Hospital Avenue Nedlands WA 6009
Country 137451 0
Australia
Phone 137451 0
+61 420790101
Fax 137451 0
Email 137451 0
[email protected]
Contact person for scientific queries
Name 137452 0
Jua
Address 137452 0
The Kids Research Institute Australia, 15 Hospital Avenue Nedlands WA 6009
Country 137452 0
Australia
Phone 137452 0
+61863191000
Fax 137452 0
Email 137452 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Investigators for this study have not yet decided on data sharing.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.