Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by Streptococci
- Registration Number
- NCT02712307
- Lead Sponsor
- Ass. Prof. Katarina Hedin
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 433
- Adults, adolescents and children ≥ 6 years of age with verified streptococcal pharyngotonsillitis.
- Signs of serious infection.
- Known hypersensitivity against penicillin.
- Chronic disease with effect on the immune response.
- Immunosuppressive treatment.
- Streptococcal tonsillitis within one month (relapse).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 days Phenoxymethylpenicillin Phenoxymethylpenicillin 1000 mg x 3 for 10 days 5 days Phenoxymethylpenicillin Phenoxymethylpenicillin 800 mg x 4 for 5 days
- Primary Outcome Measures
Name Time Method Clinical cure 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).
- Secondary Outcome Measures
Name Time Method Bacteriological cure 5-7 days after discontinuation of treatment Difference between treatment groups in the rate of bacteriological cure, defined as absence of GAS in culture.
Frequency of relapses 1 month after discontinuation of treatment Frequency of complications Within 3 months after discontinuation of treatment
Trial Locations
- Locations (17)
Närhälsan Bollebygd vårdcentral
🇸🇪Bollebygd, Sweden
Alvesta vårdcentral
🇸🇪Alvesta, Sweden
Vårdcentralen Tåbelund
🇸🇪Eslöv, Sweden
Capio Citykliniken Bunkeflo Hyllie
🇸🇪Bunkeflostrand, Sweden
Närhälsan Fristad vårdcentral
🇸🇪Fristad, Sweden
Vårdcentralen Lessebo
🇸🇪Lessebo, Sweden
Capio Citykliniken Malmö Limhamn
🇸🇪Limhamn, Sweden
Löddeköpinge vårdcentral
🇸🇪Löddeköpinge, Sweden
Vårdcentralen Sorgenfrimottagningen
🇸🇪Malmö, Sweden
Vårdcentralen Lundbergsgatan
🇸🇪Malmö, Sweden
Närhälsan Sandared vårdcentral
🇸🇪Sandared, Sweden
Vårdcentrlaen Sjöbo
🇸🇪Sjöbo, Sweden
Närhälsan Billingen vårdcentral
🇸🇪Skövde, Sweden
Närhälsan Norrmalm vårdcentral
🇸🇪Skövde, Sweden
Närhälsan Södra Ryd
🇸🇪Skövde, Sweden
Vårdcentrlaen Strandbjörket
🇸🇪Växjö, Sweden
Capio vårdcentralen Hovshaga
🇸🇪Växjö, Sweden