Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and no Antibiotic Treatment
Primary Purpose
Sore Throat, Tonsillitis
Status
Unknown status
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Phenoxymethylpenicillin
No antibiotic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Sore Throat focused on measuring sore throat, tonsillitis, randomized controlled trial, primary care, phenoxymethylpenicillin
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.
Sites / Locations
- Vårdcentralen RosenhälsanRecruiting
- Vårdcentralen KärnaRecruiting
- Vårdcentralen LundbergsgatanRecruiting
- Mariehems hälsocentral
- Ålidhems hälsocentral
- Vårdcentralen SkärvetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Phenoxymethylpenicillin group
No antibiotic treatment group
Arm Description
Patients randomized to oral phenoxymethylpenicillin 1000 mg three times daily for ten days
Patients randomized to no antibiotic treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Proportions of patients with symptom resolution at each of the days 2 through 10.
The number of days from inclusion to symptom resolution of the individual items of sore throat symptoms.
Differences in number of days from inclusion to the day the patient can put up with the pain.
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.
The number of days the patient needs to stay at home from work/school
Proportion of patients with future episodes of sore throat
Proportion of patients at follow up with eradication of each of the potential pathogens found.
Bacteriological eradication
The number of adverse events
Description of patient characteristics and outcomes in the drop-out group.
Full Information
NCT ID
NCT04083417
First Posted
September 5, 2019
Last Updated
March 10, 2020
Sponsor
Katarina Hedin
Collaborators
Umeå University, Linkoeping University, Lund University
1. Study Identification
Unique Protocol Identification Number
NCT04083417
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Katarina Hedin
Collaborators
Umeå University, Linkoeping University, Lund University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat, Tonsillitis
Keywords
sore throat, tonsillitis, randomized controlled trial, primary care, phenoxymethylpenicillin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phenoxymethylpenicillin group
Arm Type
Active Comparator
Arm Description
Patients randomized to oral phenoxymethylpenicillin 1000 mg three times daily for ten days
Arm Title
No antibiotic treatment group
Arm Type
Experimental
Arm Description
Patients randomized to no antibiotic treatment
Intervention Type
Drug
Intervention Name(s)
Phenoxymethylpenicillin
Other Intervention Name(s)
Penicillin V (PcV)
Intervention Description
tablet PcV 1000 mg x 3 for 10 days
Intervention Type
Other
Intervention Name(s)
No antibiotic treatment
Intervention Description
No prescription of antibiotics
Primary Outcome Measure Information:
Title
Differences in number of days from inclusion to resolution of symptoms
Description
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
Secondary Outcome Measure Information:
Title
Proportions of patients with symptom resolution at each of the days 2 through 10.
Time Frame
up to 10 days after inclusion
Title
The number of days from inclusion to symptom resolution of the individual items of sore throat symptoms.
Time Frame
10 days after inclusion
Title
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
Title
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
Description
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
Title
The number of days the patient needs to stay at home from work/school
Time Frame
10 days after inclusion
Title
Proportion of patients with future episodes of sore throat
Time Frame
30 days and 3 months after inclusion
Title
Proportion of patients at follow up with eradication of each of the potential pathogens found.
Description
Bacteriological eradication
Time Frame
between 18 up to 24 days
Title
The number of adverse events
Time Frame
3 months after inclusion
Title
Description of patient characteristics and outcomes in the drop-out group.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarina Hedin, Ass Prof
Phone
+46761369019
Email
katarina.hedin@rjl.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarina Hedin, Ass Prof
Organizational Affiliation
Region Jönköping County
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vårdcentralen Rosenhälsan
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Tell, MD
Facility Name
Vårdcentralen Kärna
City
Linköping
ZIP/Postal Code
586 62
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Moberg, MD
Facility Name
Vårdcentralen Lundbergsgatan
City
Malmö
ZIP/Postal Code
217 51
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mia Tyrstrup, MD,PhD
Facility Name
Mariehems hälsocentral
City
Umeå
ZIP/Postal Code
906 51
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kia Ericsson, MD
Facility Name
Ålidhems hälsocentral
City
Umeå
ZIP/Postal Code
907 36
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Lönneborg, MD
Facility Name
Vårdcentralen Skärvet
City
Växjö
ZIP/Postal Code
352 36
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Pallon, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and no Antibiotic Treatment
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