A study on sore throat i primary care comparing penicillin with no antibiotic treatment
Phase 1
- Conditions
- J03.0 PharyngotonsillitisTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2019-000756-34-SE
- Lead Sponsor
- Region Jönköping County
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
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 group A streptococcus taken
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 290
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
Ongoing antibiotic treatment
Known or suspected allergies to penicillin.
Strong suspicion of mononucleosis and positive point of care test.
Suspicion of peritonsillar abscess or indication for admittance.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To 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 ;Secondary Objective: Intensity of symptoms<br>Days with sick-leave<br>Adverse envent<br>Subgroup analysis on patients positiv for group C and G streptococci and F. necrophorum<br>;Primary end point(s): Differences in number of days from inclusion to resolution of symptoms;Timepoint(s) of evaluation of this end point: Diary at day 10
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The possible change in the self-reported items of symptoms on the rating scale for each of the days 2 through 10 <br>The number of days the patient needs to stay at home from work/school.<br>Number of day with adverse events ;Timepoint(s) of evaluation of this end point: Diary at day 10 <br>at follow-up vist after 18-24 days<br>at follow-up after 30 days <br>at follow-up after 3 months