Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and No Antibiotic Treatment

NCT04083417 | Recruiting Phase 4 DMC

• 1 other identifier: 2019-000756-34
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 6

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.

Conditions

Sore Throat; Tonsillitis

Keywords

sore throat; tonsillitis; randomized controlled trial; primary care; phenoxymethylpenicillin

Outcome Measures

Primary Outcomes (1)

• 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

  10 days after inclusion

Secondary Outcomes (9)

• Proportions of patients with symptom resolution at each of the days 2 through 10.

  up to 10 days after inclusion

• The number of days from inclusion to symptom resolution of the individual items of sore throat symptoms.

  10 days after inclusion

• Differences in number of days from inclusion to the day the patient can put up with the pain.

  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

  up to between 10 days after inclusion

• The number of days the patient needs to stay at home from work/school

  10 days after inclusion

Study Arms (2)

Phenoxymethylpenicillin group

ACTIVE COMPARATOR

Patients randomized to oral phenoxymethylpenicillin 1000 mg three times daily for ten days

Drug: Phenoxymethylpenicillin

No antibiotic treatment group

EXPERIMENTAL

Patients randomized to no antibiotic treatment

Other: No antibiotic treatment

Interventions

Phenoxymethylpenicillin DRUG

tablet PcV 1000 mg x 3 for 10 days

Also known as: Penicillin V (PcV)

Phenoxymethylpenicillin group

No antibiotic treatment OTHER

No prescription of antibiotics

No antibiotic treatment group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ' 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

You may not qualify if:

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

Sponsors & Collaborators

• Katarina Hedin: lead
• Umeå University: collaborator
• Linkoeping University: collaborator
• Lund University: collaborator
• Region Jönköping County: collaborator

Study Sites (6)

Vårdcentralen Rosenhälsan

Jönköping, 551 85, Sweden

RECRUITING

Vårdcentralen Kärna

Linköping, 586 62, Sweden

RECRUITING

Vårdcentralen Lundbergsgatan

Malmo, 217 51, Sweden

RECRUITING

Mariehems hälsocentral

Umeå, 906 51, Sweden

NOT YET RECRUITING

Ålidhems hälsocentral

Umeå, 907 36, Sweden

NOT YET RECRUITING

Vårdcentralen Skärvet

Vaxjo, 352 36, Sweden

RECRUITING

MeSH Terms

Conditions

Pharyngitis; Tonsillitis

Interventions

Penicillin V

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Katarina Hedin, Ass Prof

  Region Jönköping County

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarina Hedin, Ass Prof

CONTACT

+46761369019; katarina.hedin@rjl.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adjunct professor

Model Details: Randmization to antibiotic treatment or no antibiotic treatment

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 10, 2019
• Study Start: September 9, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6)