A study on sore throat i primary care comparing penicillin with no antibiotic treatment

The SANT - study A randomized controlled clinical trial of Streptococcus group A-negative acute tonsillitis in primary health care - a comparison of phenoxymethylpenicillin and no antibiotic treatment - The SANT-study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000756-34-SE

Enrollment

400

Registered

2019-04-17

Start date

2019-05-29

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J03.0 Pharyngotonsillitis

Interventions

Trade Name: phenoxymethylpenicillin/Kåvepenin/Avopenin/Ticacillin Product Name: phenoxymethylpenicillin Product Code: J01 CE 02 Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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 Days with sick-leave Adverse envent Subgroup analysis on patients positiv for group C and G streptococci and F. necrophorum ;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	—

Measure

Time frame

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 Days with sick-leave Adverse envent Subgroup analysis on patients positiv for group C and G streptococci and F. necrophorum ;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

Measure	Time frame
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 The number of days the patient needs to stay at home from work/school. Number of day with adverse events ;Timepoint(s) of evaluation of this end point: Diary at day 10 at follow-up vist after 18-24 days at follow-up after 30 days at follow-up after 3 months	—

Countries

Sweden

Contacts

Public ContactFuturum

Region Jönköping County

Futurum@rjl.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026