Retapamulin ointment twice daily for 5 days vs oral cephalexin twice daily for 10 days for empiric treatment of secondarily infected traumatic lesions of the skin.
BACKGROUND
Retapamulin is a novel, topical antibacterial of the pleuromutilin class in development for the treatment of secondarily infected traumatic lesions of the skin.


METHODS
The efficacy, safety, and tolerability of topical retapamulin ointment, 1% for 5 days twice daily was evaluated in 2 identical, randomized, double-blind, double-dummy, multicenter studies vs oral cephalexin, 500 mg twice daily for 10 days, in 1904 patients with secondarily infected traumatic lesions.


RESULTS
Clinical success rates were 89.5% in protocol-adherent patients receiving retapamulin compared with 91.9% for cephalexin (treatment difference, -2.5% [95% confidence interval, -5.4% to 0.5%]). In patients with Staphylococcus aureus or Streptococcus pyogenes at baseline, clinical success was 89.2% (365/409) for retapamulin and 92.6% (63/68) for cephalexin. Safety and tolerability were similar between treatments. Noncompliance (defined as using or taking <80% of doses) was recorded in 8.0% (51/636) of patients taking cephalexin compared with 0.39% (5/1268) of patients receiving retapamulin.


CONCLUSIONS
Retapamulin offers a novel, effective, and convenient topical treatment for secondarily infected traumatic lesions.
Free
Almena
A
Anniston Medical Clinic/Pinnacle Research Group, Anniston, AL, USA.
Roth
Eli
E
Dalessandro
Marybeth
M
Hiram
Joseph
J
Scangarella
Nicole
N
Shawar
Ribhi
R
White
Scott
S
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000209:etiology*; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000008:administration & dosage*; D002506:Cephalexin / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004224:Diterpenes; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D009824:Ointments; D012867:Skin / Q000293:injuries*; D012874:Skin Diseases, Infectious / Q000188:drug therapy* / Q000209:etiology; D013997:Time Factors
D000900:Anti-Bacterial Agents; D019086:Bridged Bicyclo Compounds, Heterocyclic; D004224:Diterpenes; D009824:Ointments; C508887:retapamulin; D002506:Cephalexin