Phenoxymethylpenicillin
DrugOther names: Penicillin V
NCT Number: NCT02712307
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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Notify Me6 year and older
All sexes
Interventional
Phase 4
Alvesta vårdcentral, Alvesta, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Penicillin V
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).
Time frame: 5-7 days after discontinuation of treatment
Difference between treatment groups in the rate of bacteriological cure, defined as absence of GAS in culture.
Time frame: 1 month after discontinuation of treatment
Time frame: Within 3 months after discontinuation of treatment
Ass. Prof. Katarina Hedin
Other Gov
A Randomized Controlled Study of 5 and 10 Days Treatment With Phenoxymethylpenicillin for Pharyngotonsillitis Caused by Streptococcus Group A
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