TonsillitisPhase 4NCT02712307
Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by Streptococci
A Phase 4 study testing Phenoxymethylpenicillin in people with Tonsillitis, run by Ass. Prof. Katarina Hedin at 17 sites in Sweden.
Trial summary
The primary objective of the study is to compare the clinical efficacy of 5 days (800 mg x 4) versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin (PcV) in adults, adolescents and children with streptococcal tonsillitis. Patients are recruited from 17 primary Health care centres in the south of Sweden. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Tonsillitis
- What is being tested?
- Phenoxymethylpenicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 17 sitesSweden
- Study dates
- Sep 2015to Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults, adolescents and children ≥ 6 years of age with verified streptococcal pharyngotonsillitis.
Who cannot join
- Signs of serious infection.
- Known hypersensitivity against penicillin.
- Chronic disease with effect on the immune response.
- Immunosuppressive treatment.
- Streptococcal tonsillitis within one month (relapse).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Sweden17 sites
Alvesta vårdcentral
Alvesta, 342 30
Närhälsan Bollebygd vårdcentral
Bollebygd, 517 36
Capio Citykliniken Bunkeflo Hyllie
Bunkeflostrand, 21840
Vårdcentralen Tåbelund
Eslöv, 241 31
Närhälsan Fristad vårdcentral
Fristad, 513 33
Vårdcentralen Lessebo
Lessebo, 360 50
Capio Citykliniken Malmö Limhamn
Limhamn, 216 16
Löddeköpinge vårdcentral
Löddeköpinge, 24630
Vårdcentralen Sorgenfrimottagningen
Malmö, 214 33
Vårdcentralen Lundbergsgatan
Malmö, 21715
Närhälsan Sandared vårdcentral
Sandared, 518 32
Vårdcentrlaen Sjöbo
Sjöbo, 27531
Närhälsan Billingen vårdcentral
Skövde, 541 41
Närhälsan Norrmalm vårdcentral
Skövde, 541 41
Närhälsan Södra Ryd
Skövde, 541 64
Vårdcentrlaen Strandbjörket
Vaxjo, 351 85
Capio vårdcentralen Hovshaga
Vaxjo, 35261
About this study
Official title: A Randomized Controlled Study of 5 and 10 Days Treatment With Phenoxymethylpenicillin for Pharyngotonsillitis Caused by Streptococcus Group A
The primary objective of the study is to compare the clinical efficacy of 5 days (800 mg x 4) versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin (PcV) in adults, adolescents and children with streptococcal tonsillitis. Patients are recruited from 17 primary Health care centres in the south of Sweden. Adult men and women, youth and children ≥ 6 years of age who are visiting the primary Health care for sore throat with suspected tonsillitis and meeting the criteria in accordance with current treatment recommendations for pharyngotonsillitis, ie 3-4 Centor criteria (fever≥ 38.5, tender lymph nodes, coatings of the tonsils and absence of cough) and a positive rapid antigen detection test (RADT) for Group A streptococcus (GAS) will be included in the study. Patients will be randomized to be prescribed PcV of 5 and 10 days. Each patient or guardian fills daily in a short diary including aches, fever, PcV doses, pain relievers, adverse events etc. Five to seven days after last intake of PcV the general practioner make a clinical judgement if the patient has recovered from the pharyngotonsillitis. Questions to be asked are if remaining symptoms or new symptoms of sore throat is present, if adverse events have been noted or of any extra physician visits have been made. Throat swab for semi quantitative cultures of Streptococcus group A, C and G are made at randomization and five to seven days after last intake of PcV. A study nurse will contact the patients one month and three months after the last treatment day for follow-up. If the patient has reconsulted or been hospitalised for a sore throat or possible complication, those patient records will be examined.
- Conditions
- Tonsillitis
- Being tested
- Phenoxymethylpenicillin
- Medical subject headings
- 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
| Study group | Role | What they receive |
|---|---|---|
| 5 days | Experimental | Phenoxymethylpenicillin 800 mg x 4 for 5 days Receives: Drug: Phenoxymethylpenicillin |
| 10 days | Active comparator | Phenoxymethylpenicillin 1000 mg x 3 for 10 days Receives: Drug: Phenoxymethylpenicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure
Difference between treatment groups in the rate of clinical cure. Clinical cure is defined as clinical judgement by physician and absence of Centor criteria (coating, fever and swollen Large Granular Lymphocyte glands).
Measured: 5-7 days after discontinuation of treatment
Secondary outcomes (3)
Bacteriological cure
Difference between treatment groups in the rate of bacteriological cure, defined as absence of GAS in culture.
Measured: 5-7 days after discontinuation of treatment
Frequency of relapses
Measured: 1 month after discontinuation of treatment
Frequency of complications
Measured: Within 3 months after discontinuation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionFeb 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TonsillitisStudies 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
- Masking
- None (open label)
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ass. Prof. Katarina Hedin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ass. Prof. Katarina Hedin, Public Health Agency of Sweden
- Investigators
- Sigvard Mölstad, Professor, Principal investigator, Lund UniversityKatarina Hedin, MD PhD, Principal investigator, Department of Research and Development, Region Kronoberg and Lund UniversityPär-Daniel Sundvall, MD PhD, Principal investigator, Research and Development Unit, Primary Health Care in Southern Älvsborg County and University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712307
- Sponsor's protocol ID
- FoHM/Tonsillit2015
- Other IDs
- 2015-001752-30, 2015
- Status last verified
- Nov 2018
- First submitted
- 4 Mar 2016
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tell D, Tyrstrup M, Edlund C, Rystedt K, Skoog Stahlgren G, Sundvall PD, Hedin K. Clinical course of pharyngotonsillitis with group A streptococcus treated with different penicillin V strategies, divided in groups of Centor Score 3 and 4: a prospective study in primary care. BMC Infect Dis. 2022 Nov 11;22(1):840. doi: 10.1186/s12879-022-07830-4.
PubMed 36368940Skoog Stahlgren G, Tyrstrup M, Edlund C, Giske CG, Molstad S, Norman C, Rystedt K, Sundvall PD, Hedin K. Penicillin V four times daily for five days versus three times daily for 10 days in patients with pharyngotonsillitis caused by group A streptococci: randomised controlled, open label, non-inferiority study. BMJ. 2019 Oct 4;367:l5337. doi: 10.1136/bmj.l5337.
PubMed 31585944
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of 5 and 10 Days Treatment With Phenoxymethylpenicillin for Pharyngotonsillitis Caused by Streptococcus Group A
- ClinicalTrials.gov ID
- NCT02712307
- Acronym / sponsor ID
- FoHM/Tonsillit2015
- Conditions
- Tonsillitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Ass. Prof. Katarina HedinOther government
- Study start
- Sep 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 18 Mar 2016 (estimated)
- 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.
The primary objective of the study is to compare the clinical efficacy of 5 days (800 mg x 4) versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin (PcV) in adults, adolescents and children with streptococcal tonsillitis. Patients are recruited from 17 primary Health care centres in the south of Sweden. Adult men and women, youth and children ≥ 6 years of age who are visiting the primary Health care for sore throat with suspected tonsillitis and meeting the criteria in accordance with current treatment recommendations for pharyngotonsillitis, ie 3-4 Centor criteria (fever≥ 38.5, tender lymph nodes, coatings of the tonsils and absence of cough) and a positive rapid antigen detection test (RADT) for Group A streptococcus (GAS) will be included in the study. Patients will be randomized to be prescribed PcV of 5 and 10 days. Each patient or guardian fills daily in a short diary including aches, fever, PcV doses, pain relievers, adverse events etc. Five to seven days after last intake of PcV the general practioner make a clinical judgement if the patient has recovered from the pharyngotonsillitis. Questions to be asked are if remaining symptoms or new symptoms of sore throat is present, if adverse events have been noted or of any extra physician visits have been made. Throat swab for semi quantitative cultures of Streptococcus group A, C and G are made at randomization and five to seven days after last intake of PcV. A study nurse will contact the patients one month and three months after the last treatment day for follow-up. If the patient has reconsulted or been hospitalised for a sore throat or possible complication, those patient records will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 days | Experimental | Drug: PhenoxymethylpenicillinPhenoxymethylpenicillin 800 mg x 4 for 5 days |
| 10 days | Active comparator | Drug: PhenoxymethylpenicillinPhenoxymethylpenicillin 1000 mg x 3 for 10 days |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults, adolescents and children ≥ 6 years of age with verified streptococcal pharyngotonsillitis.
Key exclusion criteria (5 listed)
- Signs of serious infection.
- Known hypersensitivity against penicillin.
- Chronic disease with effect on the immune response.
- Immunosuppressive treatment.
- Streptococcal tonsillitis within one month (relapse).
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 | Drug | 10 days, 5 days |
Primary outcome
Clinical cure
Time frame: 5-7 days after discontinuation of treatment
Difference between treatment groups in the rate of clinical cure. Clinical cure is defined as clinical judgement by physician and absence of Centor criteria (coating, fever and swollen Large Granular Lymphocyte glands).
3 secondary outcomes
Bacteriological cure
Time frame: 5-7 days after discontinuation of treatment
Frequency of relapses
Time frame: 1 month after discontinuation of treatment
Frequency of complications
Time frame: Within 3 months after discontinuation of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Derived from this study: PubMed 36368940Tell D, Tyrstrup M, Edlund C, Rystedt K, Skoog Stahlgren G, Sundvall PD, Hedin K. Clinical course of pharyngotonsillitis with group A streptococcus treated with different penicillin V strategies, divided in groups of Centor Score 3 and 4: a prospective study in primary care. BMC Infect Dis. 2022 Nov 11;22(1):840. doi: 10.1186/s12879-022-07830-4.
- Derived from this study: PubMed 31585944Skoog Stahlgren G, Tyrstrup M, Edlund C, Giske CG, Molstad S, Norman C, Rystedt K, Sundvall PD, Hedin K. Penicillin V four times daily for five days versus three times daily for 10 days in patients with pharyngotonsillitis caused by group A streptococci: randomised controlled, open label, non-inferiority study. BMJ. 2019 Oct 4;367:l5337. doi: 10.1136/bmj.l5337.
- 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. This study is not recruiting at the moment.
Sigvard Mölstad, Professor principal investigator
Lund University
Katarina Hedin, MD PhD principal investigator
Department of Research and Development, Region Kronoberg and Lund University
Pär-Daniel Sundvall, MD PhD principal investigator
Research and Development Unit, Primary Health Care in Southern Älvsborg County and University of Gothenburg
17 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 in people with Tonsillitis, run by Ass. Prof. Katarina Hedin at 17 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure (time frame: 5-7 days after discontinuation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712307, which also lists 2 linked publications.
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 14 Nov 2018.