Clinical trial NCT04083417: Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and No Antibiotic Treatment
Official title: A Randomized Controlled Clinical Trial of Streptococcus Group A-negative Acute Tonsillitis in Primary Health Care - a Comparison of Phenoxymethylpenicillin and No Antibiotic Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sore Throat
Tonsillitis
Keywords: sore throat
tonsillitis
randomized controlled trial
primary care
phenoxymethylpenicillin
Lead sponsor: Region Jönköping County
Sponsor class: OTHER_GOV
Collaborators: name: Umeå University
name: Linkoeping University
name: Lund University
name: Region JÃ¶nkÃ¶ping County
First posted: 2019-09-10
Enrollment: 260
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randmization to antibiotic treatment or no antibiotic treatment
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

' Centor score 3-4: absence of cough, anamnestic fever (temperature \>38.5°C), tender cervical lymphadenitis, and tonsillar exudates (one or both tonsils)

* Duration of symptoms \< 8 days
* Rapid antigen detection test for GAS taken and negative
* 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:

* Ongoing antibiotic treatment
* Known or suspected allergies to phenoxymethylpenicillin
* Suspicion of peritonsillar abscess or indication for admittance.

Primary outcomes:
measure: Differences in number of days from inclusion to resolution of symptoms
timeFrame: 10 days after inclusion
Secondary outcomes:
measure: Proportions of patients with symptom resolution at each of the days 2 through 10.
timeFrame: up to 10 days after inclusion
measure: The number of days from inclusion to symptom resolution of the individual items of sore throat symptoms.
timeFrame: 10 days after inclusion
measure: Differences in number of days from inclusion to the day the patient can put up with the pain.
timeFrame: up to 10 days after inclusion
measure: 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
timeFrame: up to between 10 days after inclusion
measure: The number of days the patient needs to stay at home from work/school
timeFrame: 10 days after inclusion
measure: Proportion of patients with future episodes of sore throat
timeFrame: 30 days and 3 months after inclusion
measure: Proportion of patients at follow up with eradication of each of the potential pathogens found.
timeFrame: between 18 up to 24 days
measure: The number of adverse events
timeFrame: 3 months after inclusion
measure: Description of patient characteristics and outcomes in the drop-out group.
timeFrame: 3 months
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Vårdcentralen Rosenhälsan
city: Linköping
country: Sweden
facility: Vårdcentralen Kärna
city: Malmö
country: Sweden
facility: Vårdcentralen Lundbergsgatan
city: Umeå
country: Sweden
facility: Mariehems hälsocentral
city: Umeå
country: Sweden
facility: Ålidhems hälsocentral
city: Växjö
country: Sweden
facility: Vårdcentralen Skärvet
Study officials:
affiliation: Region Jönköping County
name: Katarina Hedin, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References: