Clinical trial NCT02712307: Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by Streptococci
Official title: A Randomized Controlled Study of 5 and 10 Days Treatment With Phenoxymethylpenicillin for Pharyngotonsillitis Caused by Streptococcus Group A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tonsillitis
Lead sponsor: Public Health Agency of Sweden
Sponsor class: OTHER_GOV
First posted: 2016-03-18
Enrollment: 433
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Adults, adolescents and children ≥ 6 years of age with verified streptococcal pharyngotonsillitis.

Exclusion Criteria:

* Signs of serious infection.
* Known hypersensitivity against penicillin.
* Chronic disease with effect on the immune response.
* Immunosuppressive treatment.
* Streptococcal tonsillitis within one month (relapse).

Primary outcomes:
measure: Clinical cure
timeFrame: 5-7 days after discontinuation of treatment
Secondary outcomes:
measure: Bacteriological cure
timeFrame: 5-7 days after discontinuation of treatment
measure: Frequency of relapses
timeFrame: 1 month after discontinuation of treatment
measure: Frequency of complications
timeFrame: Within 3 months after discontinuation of treatment
Other outcomes:
Locations:
city: Alvesta
country: Sweden
facility: Alvesta vårdcentral
city: Bollebygd
country: Sweden
facility: Närhälsan Bollebygd vårdcentral
city: Bunkeflostrand
country: Sweden
facility: Capio Citykliniken Bunkeflo Hyllie
city: Eslöv
country: Sweden
facility: Vårdcentralen Tåbelund
city: Fristad
country: Sweden
facility: Närhälsan Fristad vårdcentral
city: Lessebo
country: Sweden
facility: Vårdcentralen Lessebo
city: Limhamn
country: Sweden
facility: Capio Citykliniken Malmö Limhamn
city: Löddeköpinge
country: Sweden
facility: Löddeköpinge vårdcentral
city: Malmö
country: Sweden
facility: Vårdcentralen Sorgenfrimottagningen
city: Malmö
country: Sweden
facility: Vårdcentralen Lundbergsgatan
city: Sandared
country: Sweden
facility: Närhälsan Sandared vårdcentral
city: Sjöbo
country: Sweden
facility: Vårdcentrlaen Sjöbo
city: Skövde
country: Sweden
facility: Närhälsan Billingen vårdcentral
city: Skövde
country: Sweden
facility: Närhälsan Norrmalm vårdcentral
city: Skövde
country: Sweden
facility: Närhälsan Södra Ryd
city: Växjö
country: Sweden
facility: Vårdcentrlaen Strandbjörket
city: Växjö
country: Sweden
facility: Capio vårdcentralen Hovshaga
Study officials:
affiliation: Lund University
name: Sigvard Mölstad, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Research and Development, Region Kronoberg and Lund University
name: Katarina Hedin, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research and Development Unit, Primary Health Care in Southern Älvsborg County and University of Gothenburg
name: Pär-Daniel Sundvall, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.