A Phase 4 interventional study of Phenoxymethylpenicillin and No antibiotic treatment in Sore Throat and Tonsillitis, sponsored by Katarina Hedin. Recruiting at 6 sites in Sweden. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Katarina Hedin · Phase 4, Interventional, and Treatment
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.
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's planned enrollment of 260 is above the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →Katarina Hedin is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Tonsillitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pharyngitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
' Centor score 3-4: absence of cough, anamnestic fever (temperature >38.5°C), tender cervical lymphadenitis, and tonsillar exudates (one or both tonsils)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to oral phenoxymethylpenicillin 1000 mg three times daily for ten days
Drug: Phenoxymethylpenicillin
Patients randomized to no antibiotic treatment
Other: No antibiotic treatment
tablet PcV 1000 mg x 3 for 10 days
Also known as: Penicillin V (PcV)
No prescription of antibiotics
Differences in number of days from inclusion to resolution of symptoms
Differences between the randomized groups. Symptom resolution is defined as the first day the item sore throat and difficulty swallowing is scored less than moderately bad
Time frame: 10 days after inclusion
Proportions of patients with symptom resolution at each of the days 2 through 10.
Time frame: up to 10 days after inclusion
The number of days from inclusion to symptom resolution of the individual items of sore throat symptoms.
Time frame: 10 days after inclusion
Differences in number of days from inclusion to the day the patient can put up with the pain.
Time frame: up to 10 days after inclusion
The possible change in the self-reported items of symptoms on the rating scale for each of the days 2 through 10 and describe the break through day for improvement
The rating is on a 7-point Likert scale 0=no symptoms, 1= very little, 2=slight, 3=moderately bad, 4=bad, 5=very bad, 6=as bad as it could be.
Time frame: up to between 10 days after inclusion
The number of days the patient needs to stay at home from work/school
Time frame: 10 days after inclusion
Proportion of patients with future episodes of sore throat
Time frame: 30 days and 3 months after inclusion
Proportion of patients at follow up with eradication of each of the potential pathogens found.
Bacteriological eradication
Time frame: between 18 up to 24 days
The number of adverse events
Time frame: 3 months after inclusion
Description of patient characteristics and outcomes in the drop-out group.
Time frame: 3 months
Plan to share: No
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Katarina Hedin