Sore ThroatPhase 4SANTNCT04083417
Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and No Antibiotic Treatment
A Phase 4 study testing Phenoxymethylpenicillin and No antibiotic treatment in people with Sore Throat and Tonsillitis, run by Katarina Hedin at 6 sites in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Sore Throat, Tonsillitis
- What is being tested?
- Phenoxymethylpenicillin and No antibiotic treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 6 sitesSweden
- Study dates
- 9 Sep 2019to Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ' 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
Who cannot join
- Ongoing antibiotic treatment
- Known or suspected allergies to phenoxymethylpenicillin
- Suspicion of peritonsillar abscess or indication for admittance.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Sweden6 sites, 6 recruiting
- Recruiting
Vårdcentralen Rosenhälsan
Jönköping, 551 85
David Tell, MD
- Recruiting
Vårdcentralen Kärna
Linköping, 586 62
Anna Moberg, MD
- Recruiting
Vårdcentralen Lundbergsgatan
Malmö, 217 51
Mia Tyrstrup, MD,PhD
- Not yet recruiting
Mariehems hälsocentral
Umeå, 906 51
Kia Ericsson, MD
- Not yet recruiting
Ålidhems hälsocentral
Umeå, 907 36
Helena Lönneborg, MD
- Recruiting
Vårdcentralen Skärvet
Vaxjo, 352 36
Jon Pallon, MD, PhD
About this study
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
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.
Read more
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.
- Conditions
- Sore Throat, Tonsillitis
- Being tested
- Phenoxymethylpenicillin, No antibiotic treatment
- Keywords
- sore throat, tonsillitis, randomized controlled trial, primary care, phenoxymethylpenicillin
- Medical subject headings
- Pharyngitis, Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenoxymethylpenicillinDrug
Also called Penicillin V (PcV)
tablet PcV 1000 mg x 3 for 10 days
No antibiotic treatmentOther
No prescription of antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Phenoxymethylpenicillin group | Active comparator | Patients randomized to oral phenoxymethylpenicillin 1000 mg three times daily for ten days Receives: Drug: Phenoxymethylpenicillin |
| No antibiotic treatment group | Experimental | Patients randomized to no antibiotic treatment Receives: Other: No antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days after inclusion
Secondary outcomes (9)
Proportions of patients with symptom resolution at each of the days 2 through 10.
Measured: up to 10 days after inclusion
The number of days from inclusion to symptom resolution of the individual items of sore throat symptoms.
Measured: 10 days after inclusion
Differences in number of days from inclusion to the day the patient can put up with the pain.
Measured: 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.
Measured: up to between 10 days after inclusion
The number of days the patient needs to stay at home from work/school
Measured: 10 days after inclusion
Proportion of patients with future episodes of sore throat
Measured: 30 days and 3 months after inclusion
Proportion of patients at follow up with eradication of each of the potential pathogens found.
Bacteriological eradication
Measured: between 18 up to 24 days
The number of adverse events
Measured: 3 months after inclusion
Description of patient characteristics and outcomes in the drop-out group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start9 Sep 2019
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randmization to antibiotic treatment or no antibiotic treatment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katarina Hedin
- Sponsor type
- Other government
- Collaborators
- Umeå University, Linkoeping University, Lund University, Region Jönköping County
- Responsible party
- Sponsor-investigator, Katarina Hedin, Region Jönköping County
- Investigators
- Katarina Hedin, Ass Prof, Principal investigator, Region Jönköping County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083417
- Sponsor's protocol ID
- 2019-000756-34
- Other IDs
- 2019
- Acronym
- SANT
- Status last verified
- Dec 2024
- First submitted
- 5 Sep 2019
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04083417
- Acronym / sponsor ID
- SANT / 2019-000756-34
- Conditions
- Sore Throat, Tonsillitis
- Keywords
- sore throat, tonsillitis, randomized controlled trial, primary care, phenoxymethylpenicillin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Katarina HedinOther government
- Collaborators
- Umeå University, Linkoeping University, Lund University, Region Jönköping County
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randmization to antibiotic treatment or no antibiotic treatment
| Arm | Type | Receives |
|---|---|---|
| Phenoxymethylpenicillin group | Active comparator | Drug: PhenoxymethylpenicillinPatients randomized to oral phenoxymethylpenicillin 1000 mg three times daily for ten days |
| No antibiotic treatment group | Experimental | Other: No antibiotic treatmentPatients randomized to no antibiotic treatment |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ' 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
Key exclusion criteria (3 listed)
- Ongoing antibiotic treatment
- Known or suspected allergies to phenoxymethylpenicillin
- Suspicion of peritonsillar abscess or indication for admittance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenoxymethylpenicillinAlso: Penicillin V (PcV)tablet PcV 1000 mg x 3 for 10 days | Drug | Phenoxymethylpenicillin group |
| No antibiotic treatmentNo prescription of antibiotics | Other | No antibiotic treatment group |
Primary outcome
Differences in number of days from inclusion to resolution of symptoms
Time frame: 10 days after inclusion
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
9 secondary outcomes
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
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katarina Hedin, Ass Prof principal investigator
Region Jönköping County
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phenoxymethylpenicillin and No antibiotic treatment in people with Sore Throat and Tonsillitis, run by Katarina Hedin at 6 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katarina Hedin, Ass Prof (+46761369019, katarina.hedin@rjl.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in number of days from inclusion to resolution of symptoms (time frame: 10 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.