Journal Article

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

Giske, Christian G, Rystedt, Karin, Tyrstrup, Mia, Skoog Ståhlgren, Gunilla, Norman, Christer, Edlund, Charlotta, Sundvall, Pär-Daniel, Mölstad, Sigvard, Hedin, Katarina

2019

Overview

AbstractObjectiveTo determine whether total exposure to penicillin V can be reduced while maintaining adequate clinical efficacy when treating pharyngotonsillitis caused by group A streptococci.DesignOpen label, randomised controlled non-inferiority study.Setting17 primary healthcare centres in Sweden between September 2015 and February 2018.ParticipantsPatients aged 6 years and over with pharyngotonsillitis caused by group A streptococci and three or four Centor criteria (fever ≥38.5°C, tender lymph nodes, coatings of the tonsils, and absence of cough).InterventionsPenicillin V 800 mg four times daily for five days (total 16 g) compared with the current recommended dose of 1000 mg three times daily for 10 days (total 30 g).Main outcome measuresPrimary outcome was clinical cure five to seven days after the end of antibiotic treatment. The non-inferiority margin was prespecified to 10 percentage points. Secondary outcomes were bacteriological eradication, time to relief of symptoms, frequency of relapses, complications and new tonsillitis, and patterns of adverse events.ResultsPatients (n=433) were randomly allocated to the five day (n=215) or 10 day (n=218) regimen. Clinical cure in the per protocol population was 89.6% (n=181/202) in the five day group and 93.3% (n=182/195) in the 10 day group (95% confidence interval −9.7 to 2.2). Bacteriological eradication was 80.4% (n=156/194) in the five day group and 90.7% (n=165/182) in the 10 day group. Eight and seven patients had relapses, no patients and four patients had complications, and six and 13 patients had new tonsillitis in the five day and 10 day groups, respectively. Time to relief of symptoms was shorter in the five day group. Adverse events were mainly diarrhoea, nausea, and vulvovaginal disorders; the 10 day group had higher incidence and longer duration of adverse events.ConclusionsPenicillin V four times daily for five days was non-inferior in clinical outcome to penicillin V three times daily for 10 days in patients with pharyngotonsillitis caused by group A streptococci. The number of relapses and complications did not differ between the two intervention groups. Five day treatment with penicillin V four times daily might be an alternative to the currently recommended 10 day regimen.Trial registrationEudraCT 2015-001752-30; ClinicalTrials.gov NCT02712307.

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group Ltd
• Subject: acute sore throat / Adolescent / Adult / Aged / Anti-Bacterial Agents - administration & dosage / Anti-Bacterial Agents - adverse effects / Antibiotics / Antigens / Antimicrobial agents / Child / Clinical Medicine / Cough / Diarrhea / Drug Administration Schedule / Drug dosages / duration / Female / Fever / Health Sciences / Humans / Hälsovetenskap / Klinisk medicin / Lymph nodes / Lymphatic system / Male / management / Middle Aged / Nausea / old / Patients / Penicillin / Penicillin V / Penicillin V - administration & dosage / Penicillin V - adverse effects / pharyngitis / Pharyngitis - drug therapy / Pharyngotonsillitis / Primary care / Primary Health Care / Streptococcal Infections - drug therapy / Streptococcus / Streptococcus infections / Streptococcus pyogenes - drug effects / therapy / Tonsillitis / Tonsillitis - drug therapy / Treatment Outcome / trial / Young Adult