Five day clarithromycin modified release versus 10 day penicillin V for group A streptococcal pharyngitis: a multi-centre, open-label, randomized study
Henri Portier1, Jamila Filipecki, Philippe Weber
1Dijon University Hospital, Hôpital du Bocage, Service des Maladies Infectieuses, 2 boulevard de Lattre de Tassigny, 21034, Dijon, France. henriporter@chu-dijon.fr
Objective:
A multicentre, comparative, randomized, open-label, Phase III trial evaluated the efficacy and tolerability of clarithromycin modified release (MR) versus penicillin V for pharyngitis due to group A beta-haemolytic streptococci (GABHS).
Methods:
Three hundred and forty-nine patients (12-40 years) with acute pharyngotonsillitis and a positive Streptococcus A antigen immunoassay test were randomized to receive clarithromycin MR 500 mg od for 5 days or penicillin 590 mg tds for 10 days. Patients were clinically evaluated and a throat swab for culture obtained before treatment, after treatment (day 8 or 13 depending on the treatment arm) and at the follow-up visit (day 30). The main criterion for efficacy was the bacteriological cure rate after treatment.
Results:
Three hundred and forty-nine patients were considered for the intent-to-treat analysis. After treatment, clinical cure rates were 88.1% in the clarithromycin group and 92.4% in the penicillin group, and eradication rates were 82.8% and 83.6%, respectively. There were no statistically significant differences between the two treatments. Three hundred and three (87%) patients had a positive culture before treatment, among which 29 (9.7%) were found to be clarithromycin resistant. Two hundred and thirty-nine patients were clinically and bacteriologically evaluable for per protocol analysis. After treatment, clinical cure rates were 95.2% in the clarithromycin group and 97.3% in the penicillin group, and eradication rates were 94.4% and 92%, respectively. No statistically significant difference was shown. Adverse events occurred in 46 patients of the clarithromycin group and 31 of the penicillin group (with no statistical difference). Most of them were of mild or moderate severity.
Conclusion:
Clarithromycin MR administered once daily for 5 days is as safe and effective as penicillin V administered three times a day for 10 days in the treatment of GABHS pharyngitis.
Insights
Clarithromycin modified release (MR) offers a safe and effective 5-day treatment for group A beta-haemolytic streptococci (GABHS) pharyngitis. This antibiotic is comparable to penicillin V, demonstrating similar efficacy and tolerability in clinical trials.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Trials
Background:
- Pharyngitis caused by group A beta-haemolytic streptococci (GABHS) is a common bacterial infection.
- Penicillin V has been the standard treatment, but adherence can be challenging due to multiple daily doses.
Purpose of the Study:
- To compare the efficacy and tolerability of clarithromycin modified release (MR) with penicillin V for GABHS pharyngitis.
- To evaluate a shorter, once-daily dosing regimen of clarithromycin MR.
Main Methods:
- A multicentre, randomized, open-label Phase III trial involving 349 patients aged 12-40 years with confirmed GABHS pharyngitis.
- Patients received either clarithromycin MR 500 mg once daily for 5 days or penicillin V 590 mg three times daily for 10 days.
- Efficacy was assessed by clinical evaluation and bacteriological cure rates post-treatment.
Main Results:
- No statistically significant differences were observed in clinical cure rates (clarithromycin: 88.1%, penicillin: 92.4%) or eradication rates (clarithromycin: 82.8%, penicillin: 83.6%) in the intent-to-treat analysis.
- Per-protocol analysis showed similar high cure and eradication rates for both treatments.
- Adverse events were comparable between the clarithromycin MR and penicillin V groups, mostly mild to moderate.
Conclusions:
- Clarithromycin MR administered once daily for 5 days is a safe and effective alternative to penicillin V for treating GABHS pharyngitis.
- The simplified dosing regimen of clarithromycin MR may improve patient adherence compared to standard penicillin V therapy.
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