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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001752-30 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 days | Experimental | Phenoxymethylpenicillin 800 mg x 4 for 5 days |
|
| 10 days | Active Comparator | Phenoxymethylpenicillin 1000 mg x 3 for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenoxymethylpenicillin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 5-7 days after discontinuation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Bacteriological cure | Difference between treatment groups in the rate of bacteriological cure, defined as absence of GAS in culture. | 5-7 days after discontinuation of treatment |
| Frequency of relapses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sigvard Mölstad, Professor | Lund University | Principal Investigator |
| Katarina Hedin, MD PhD | Department of Research and Development, Region Kronoberg and Lund University | Principal Investigator |
| Pär-Daniel Sundvall, MD PhD | Research and Development Unit, Primary Health Care in Southern Älvsborg County and University of Gothenburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alvesta vårdcentral | Alvesta | 342 30 | Sweden | |||
| Närhälsan Bollebygd vårdcentral |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36368940 | Derived | 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. | |
| 31585944 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 10, 2021 | |
| Reset | Apr 8, 2021 |
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| 1 month after discontinuation of treatment |
| Frequency of complications | Within 3 months after discontinuation of treatment |
| Bollebygd |
| 517 36 |
| Sweden |
| Capio Citykliniken Bunkeflo Hyllie | Bunkeflostrand | 21840 | Sweden |
| Vårdcentralen Tåbelund | Eslöv | 241 31 | Sweden |
| Närhälsan Fristad vårdcentral | Fristad | 513 33 | Sweden |
| Vårdcentralen Lessebo | Lessebo | 360 50 | Sweden |
| Capio Citykliniken Malmö Limhamn | Limhamn | 216 16 | Sweden |
| Löddeköpinge vårdcentral | Löddeköpinge | 24630 | Sweden |
| Vårdcentralen Sorgenfrimottagningen | Malmö | 214 33 | Sweden |
| Vårdcentralen Lundbergsgatan | Malmö | 21715 | Sweden |
| Närhälsan Sandared vårdcentral | Sandared | 518 32 | Sweden |
| Vårdcentrlaen Sjöbo | Sjöbo | 27531 | Sweden |
| Närhälsan Billingen vårdcentral | Skövde | 541 41 | Sweden |
| Närhälsan Norrmalm vårdcentral | Skövde | 541 41 | Sweden |
| Närhälsan Södra Ryd | Skövde | 541 64 | Sweden |
| Vårdcentrlaen Strandbjörket | Vaxjo | 351 85 | Sweden |
| Capio vårdcentralen Hovshaga | Vaxjo | 35261 | Sweden |
| Skoog 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 10, 2021 | Apr 8, 2021 |
| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D010404 | Penicillin V |
| ID | Term |
|---|---|
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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