A randomized controlled study of 5 and 10 days treatment with phenoxymethylpenicillin for pharyngotonsillitis caused by streptococcus group A – a protocol study

BMC Infectious Diseases

Study Protocol

Sigvard Mölstad¹  Katarina Hedin²  Christian G. Giske³  Pär-Daniel Sundvall⁴  Gunilla Skoog⁵  Charlotta Edlund⁵  Christer Norman⁶ 

[1] Department of Clinical Sciences, Malmö, Family Medicine, Lund University, Lund, Sweden;Department of Clinical Sciences, Malmö, Family Medicine, Lund University, Lund, Sweden;Department of Research and Development, Region Kronoberg, Växjö, Sweden;Division of Clinical Microbiology, Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden;Department of Clinical Microbiology, Karolinska University Hospital, Stockholm, Sweden;Närhälsan Research and Development Primary Health Care, Region Västra Götaland, R & D Center Södra Älvsborg, Sven Eriksonsplatsen 4, SE-503 38, Borås, Sweden;Department of Public Health and Community Medicine/Primary Health Care, Institute of Medicine, Sahlgrenska Academy at the University of Gothenburg, Box 454, SE-405 30, Göteborg, Sweden;Unit for Antibiotics and Infection Control, The Public Health Agency of Sweden, Solna, Sweden;Department of Medicine Solna, Division of Infectious Diseases, Karolinska Institute, Stockholm, Sweden;Unit for Antibiotics and Infection Control, The Public Health Agency of Sweden, Solna, Sweden;Salem Primary Health Care Center (PHCC), Säbytorgsvägen 6, SE-144 30, Rönninge, Sweden;

关键词: Pharyngotonsillitis;    Treatment duration;    Phenoxymethylpenicillin;    Penicillin V;    RCT;    Primary health care;    Streptococcus;    GAS;    Centor criteria;   

DOI  :  10.1186/s12879-016-1813-7

 received in 2016-06-30, accepted in 2016-08-30,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundIn 2014 the Swedish government assigned to The Public Health Agency of Sweden to conduct studies to evaluate optimal use of existing antibiotic agents. The aim is to optimize drug use and dosing regimens to improve the clinical efficacy. The present study was selected following a structured prioritizing process by independent experts.MethodsThis phase IV study is a randomized, open-label, multicenter study with non-inferiority design regarding the therapeutic use of penicillin V with two parallel groups. The overall aim is to study if the total exposure with penicillin V can be reduced from 1000 mg three times daily for 10 days to 800 mg four times daily for 5 days when treating Streptococcus pyogenes (Lancefield group A) pharyngotonsillitis. Patients will be recruited from 17 primary health care centers in Sweden. Adult men and women, youth and children ≥6 years of age who consult for sore throat and is judged to have a pharyngotonsillitis, with 3–4 Centor criteria and a positive rapid test for group A streptococci, will be included in the study. The primary outcome is clinical cure 5–7 days after discontinuation of antibiotic treatment. Follow-up controls will be done by telephone after 1 and 3 months. Throat symptoms, potential relapses and complications will be monitored, as well as adverse events. Patients (n = 432) will be included during 2 years.DiscussionIn the era of increasing antimicrobial resistance and the shortage of new antimicrobial agents it is necessary to revisit optimal usage of old antibiotics. Old antimicrobial drugs are often associated with inadequate knowledge on pharmacokinetics and pharmacodynamics and lack of optimized dosing regimens based on randomized controlled clinical trials. If a shorter and more potent treatment regimen is shown to be equivalent with the normal 10 day regimen this can imply great advantages for both patients (adherence, adverse events, resistance) and the community (resistance, drug costs).Trial registrationEudraCT number 2015-001752-30. Protocol FoHM/Tonsillit2015 date 22 June 2015, version 2. Approved by MPA of Sweden 3 July 2015, Approved by Regional Ethical Review Board in Lund, 25 June 2015.

【 授权许可】

CC BY   
© The Author(s). 2016