Comparative evaluation of 2 g single dose versus conventional dose azithromycin in uncomplicated skin and skin structure infections.
OBJECTIVE
Uncomplicated skin and skin structure infections (uSSSIs) are a common clinical problem. Majority are caused by staphylococci and streptococci. Different oral antibiotics are used for uSSSI, with comparable efficacy but varying treatment duration, cost, and adverse event profile. Azithromycin is used in uSSSI in adults conventionally in a dose of 500 mg once for 5 days. The extensive tissue distribution of the drug and its long elimination half-life prompted us to explore whether a single 2 g dose of the drug would produce a response in uSSSI comparable to conventional dosing.


METHODS
We conducted a parallel group, open-label, randomized, controlled trial (CTRI/2015/07/005969) with subjects of either sex, ≥12 years of age, presenting with uSSSI to the dermatology outpatient department. One group (n = 146) received 2 g single supervised dose while the other (n = 146) received conventional dose of 500 mg once daily for 5 days. Subjects were followed up on day 4 and day 8. Complete clinical cure implied complete healing of lesions, without residual signs or symptoms, within 7 days.


RESULTS
High cure rate was observed in both arms (97.97% and 98.63%, respectively) along with noticeable improvement in symptom profile from baseline but without statistically significant difference between groups. However, excellent adherence (defined as no tablets missed) was better in single dosing arm (98.65% vs. 86.30%). Tolerability was also comparable between groups with the majority of adverse events encountered being gastrointestinal in nature and mild.


CONCLUSIONS
Single 2 g azithromycin dose achieved the same result as conventional azithromycin dosing in uSSSI with comparable tolerability but with the advantage of assured adherence. This dose can, therefore, be recommended as an alternative and administration supervised if feasible.
Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.
Sudipta Kumar
SK
Dey
Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.
Amal Kanti
AK
Das
Department of Dermatology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.
Sumit
S
Sen
Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.
Avijit
A
Hazra
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D017963:Azithromycin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D011446:Prospective Studies; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
D000900:Anti-Bacterial Agents; D017963:Azithromycin
Azithromycin; dermatology; randomized controlled trial; uncomplicated skin and skin structure infection