Overview
Sponsor-declared trial summary
Tonsilitis
Determine if PcV compared to no antibiotic treatment (care as usual) reduces the duration of symptoms in patients with severe (Centor score 3-4), GAS-negative AT
Key facts
- Sponsor
- Region Joenkoepings Laen
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 2 Sep 2019 → ongoing
- Decision date (initial)
- 2023-11-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508542-18-00
- EudraCT number
- 2019-000756-34
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Determine if PcV compared to no antibiotic treatment (care as usual) reduces the duration of symptoms in patients with severe (Centor score 3-4), GAS-negative AT
Conditions and MedDRA coding
Tonsilitis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Adult and young adult persons ages 15 years and older with symptoms of sore throat and or pain on swallowing
- Centor score 3-4: absence of cough, anamnestic fever (temperature above 38.5°C), tender lymphadenitis, and tonsillar exudates (one or both tonsils)
- Duration of symptoms < 8 days
- A RADT for GAS taken
- Willing and able to give informed consent. Subjects under 18 years of age must in addition have the consent from both parents/caretakers
Exclusion criteria 4
- Ongoing antibiotic treatment
- Known or suspected allergies to penicillin
- Strong suspicion of mononucleosis and positive point of care test
- Suspicion of PTA or indication for admittance
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Differences in number of days from inclusion to resolution of symptoms. Student t-test will be used to determine differences in number of days from inclusion to resolution of all symptoms between study group 1 and study group 2.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
—
SCP968089 · ATC
- Route of administration
- ORAL USE
- Max daily dose
- 3 g gram(s)
- Max total dose
- 30 g gram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CE02 — PHENOXYMETHYLPENICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Joenkoepings Laen
- Sponsor organisation
- Region Joenkoepings Laen
- Address
- Futurum Verksamhetsnara Funktion, Lanssjukhuset Ryhov Hus B 4 Lanssjukhuset Ryhov Hus B 4
- City
- Jonkoping
- Postcode
- 551 85
- Country
- Sweden
Scientific contact point
- Organisation
- Region Joenkoepings Laen
- Contact name
- Katarina Hedin
Public contact point
- Organisation
- Region Joenkoepings Laen
- Contact name
- Katarina Hedin
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 390 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2019-09-02 | 2019-09-09 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-23 | Sweden | Acceptable 2023-10-31
|
2023-11-01 |