Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and no Antibiotic Treatment
Status:
Recruiting
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
Sore throat is the second most common cause of antibiotic prescribing in primary care in
Sweden. Guidelines for sore throat focus on identifying people with sore throat where there
are 3 and 4 specified criteria and where near patient tests identify group A streptococci
(GAS). In these cases, phenoxymethylpenicillin is recommended.
Studies that have identified microorganisms in sore throat show that there are other bacteria
and viruses than GAS, that give similar symptoms and that sometimes no microorganism is
trapped despite pronounced symptoms. In recent years, a bacterium F. necrophorum has been
identified, which is found in increased incidence of sore throat, but it is also found in
healthy individuals. In clinical practice, many patients are treated with penicillin even if
GAS is not captured. This may be because the doctor perceives the patient as sick or because
other bacteria are not caught with a near patient test which causes the doctor to treat
anyway.
The specific aims are to in patients with GAS-negative sore throat and 3 and 4 criteria, aged
15 years and older in primary care, study whether phenoxymethylpenicillin treatment shortens
the duration of the disease, reduces the symptom intensity and sickness absence, and
investigates the importance of other microorganisms than GAS in sore throat.
The study is a randomized controlled trial in which patients with sore throat are randomized
to phenoxymethylpenicillin 3 times daily for 10 days or to no antibiotic therapy. There will
also be and a reference group with severe (Centor score 3-4), GAS-positive acute tonsillitis.
Blood samples for inflammatory and immunological response to infections are taken. Throat
samples for culture of F. necrophorum and streptococcal groups C and G, as well as polymerase
chain reaction (PCR) analysis for bacteria and viruses are also taken at inclusion and at
follow-up.
The outcome will be followed in a patient diary for 10 days and at a return visit after 18-24
days where the clinical outcome is asked for and where the blood- and throat samples are
repeated.
Follow-up will also takes place via e-mail after 1 and 3 months.
Phase:
Phase 4
Details
Lead Sponsor:
Katarina Hedin
Collaborators:
Linkoeping University Lund University Umeå University
Treatments:
Anti-Bacterial Agents Antibiotics, Antitubercular Penicillin V Penicillins