Cloxacillin versus pristinamycin for superficial pyodermas: a randomized, open-label, non-inferiority study.
BACKGROUND
Superficial pyodermas may require systemic antibiotics. In a previous open-label trial, oxacillin and pristinamycin achieved similar cure rates, but its design was not truly that of a non-inferiority study.


OBJECTIVE
To assess the efficacy and safety of oral cloxacillin versus pristinamycin (both 2 g/day) to treat superficial pyodermas.


METHODS
Multicentre, parallel-group, open-label, randomized non-inferiority trial.


RESULTS
French general practitioners in private practice included 334 out-patients (mean age: 42 years). At the follow-up (day 14), the cure rates (primary efficacy end point) for the intent-to-treat populations were 80.7% (138/171) for cloxacillin and 82.8% (135/163) for pristinamycin. The observed difference between cure rates was -2.1%, with the lower limit of the two-sided 95% confidence interval higher than the non-inferiority threshold of -15%. The per-protocol analysis yielded similar results. Therapy was discontinued for 10 patients (cloxacillin: 1, pristinamycin: 9; p = 0.01).


CONCLUSIONS
Cloxacillin could be an alternative to pristinamycin in out-patients with superficial pyodermas.
Chosidow
O
O
Department of Internal Medicine, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris and Université Paris-VI, France. olivier.chosidow@psl.ap-hop-paris.fr
Bernard
P
P
Berbis
P
P
Humbert
P
P
Crickx
B
B
Jarlier
V
V
D000284:Administration, Oral; D003023:Cloxacillin / Q000008:administration & dosage*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D008297:Male; D025762:Pristinamycin / Q000008:administration & dosage*; D011711:Pyoderma / Q000175:diagnosis* / Q000188:drug therapy*; D012016:Reference Values; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome
D025762:Pristinamycin; D003023:Cloxacillin