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

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ClinicalTrials.gov Identifier: NCT04083417
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : March 11, 2020
Sponsor:
Collaborators:
Umeå University
Linkoeping University
Lund University
Information provided by (Responsible Party):
Katarina Hedin, Region Jönköping County

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.


Condition or disease Intervention/treatment Phase
Sore Throat Tonsillitis Drug: Phenoxymethylpenicillin Other: No antibiotic treatment Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: 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
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Phenoxymethylpenicillin group
Patients randomized to oral phenoxymethylpenicillin 1000 mg three times daily for ten days
Drug: Phenoxymethylpenicillin
tablet PcV 1000 mg x 3 for 10 days
Other Name: Penicillin V (PcV)

Experimental: No antibiotic treatment group
Patients randomized to no antibiotic treatment
Other: No antibiotic treatment
No prescription of antibiotics




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Proportions of patients with symptom resolution at each of the days 2 through 10. [ Time Frame: up to 10 days after inclusion ]
  2. The number of days from inclusion to symptom resolution of the individual items of sore throat symptoms. [ Time Frame: 10 days after inclusion ]
  3. 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 ]
  4. 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 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.

  5. The number of days the patient needs to stay at home from work/school [ Time Frame: 10 days after inclusion ]
  6. Proportion of patients with future episodes of sore throat [ Time Frame: 30 days and 3 months after inclusion ]
  7. Proportion of patients at follow up with eradication of each of the potential pathogens found. [ Time Frame: between 18 up to 24 days ]
    Bacteriological eradication

  8. The number of adverse events [ Time Frame: 3 months after inclusion ]
  9. Description of patient characteristics and outcomes in the drop-out group. [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083417


Contacts
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Contact: Katarina Hedin, Ass Prof +46761369019 katarina.hedin@rjl.se

Locations
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Sweden
Vårdcentralen Rosenhälsan Recruiting
Jönköping, Sweden, 551 85
Contact: David Tell, MD         
Vårdcentralen Kärna Recruiting
Linköping, Sweden, 586 62
Contact: Anna Moberg, MD         
Vårdcentralen Lundbergsgatan Recruiting
Malmö, Sweden, 217 51
Contact: Mia Tyrstrup, MD,PhD         
Mariehems hälsocentral Not yet recruiting
Umeå, Sweden, 906 51
Contact: Kia Ericsson, MD         
Ålidhems hälsocentral Not yet recruiting
Umeå, Sweden, 907 36
Contact: Helena Lönneborg, MD         
Vårdcentralen Skärvet Recruiting
Växjö, Sweden, 352 36
Contact: Jon Pallon, MD, PhD         
Sponsors and Collaborators
Katarina Hedin
Umeå University
Linkoeping University
Lund University
Investigators
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Principal Investigator: Katarina Hedin, Ass Prof Region Jönköping County
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Responsible Party: Katarina Hedin, Associated professor, research leader, Region Jönköping County
ClinicalTrials.gov Identifier: NCT04083417    
Other Study ID Numbers: 2019-000756-34
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Katarina Hedin, Region Jönköping County:
sore throat
tonsillitis
randomized controlled trial
primary care
phenoxymethylpenicillin
Additional relevant MeSH terms:
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Pharyngitis
Tonsillitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Penicillins
Penicillin V
Anti-Infective Agents