Topical retapamulin ointment, 1%, versus sodium fusidate ointment, 2%, for impetigo: a randomized, observer-blinded, noninferiority study.
BACKGROUND
Retapamulin is a novel pleuromutilin antibacterial developed for topical use.


OBJECTIVE
To compare the efficacy and safety of retapamulin ointment, 1% (twice daily for 5 days), with sodium fusidate ointment, 2% (3 times daily for 7 days), in impetigo.


METHODS
A randomized (2:1 retapamulin to sodium fusidate), observer-blinded, noninferiority, phase III study in 519 adult and pediatric (aged > or = 9 months) subjects.


RESULTS
Retapamulin and sodium fusidate had comparable clinical efficacies (per-protocol population: 99.1 and 94.0%, respectively; difference: 5.1%, 95% confidence interval: 1.1-9.0%, p = 0.003; intent-to-treat population: 94.8 and 90.1%, respectively; difference: 4.7%, 95% confidence interval: -0.4 to 9.7%, p = 0.062). Bacteriological efficacies were similar. Success rates in the small numbers of sodium-fusidate-, methicillin- and mupirocin-resistant Staphylococcus aureus were good for retapamulin (9/9, 8/8 and 6/6, respectively). Both drugs were well tolerated.


CONCLUSIONS
Retapamulin is a highly effective and convenient new treatment option for impetigo, with efficacy against isolates resistant to existing therapies.
Oranje
Arnold P
AP
Department of Dermatology and Venereology (Pediatric Dermatology), University Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands. arnold.p.oranje@inter.nl.net
Chosidow
Olivier
O
Sacchidanand
Sarvajnamurthy
S
Todd
Gail
G
Singh
Krishan
K
Scangarella
Nicole
N
Shawar
Ribhi
R
Twynholm
Monique
M
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004224:Diterpenes; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D005672:Fusidic Acid / Q000008:administration & dosage*; D006801:Humans; D007169:Impetigo / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D009824:Ointments; D016037:Single-Blind Method; D012867:Skin / Q000382:microbiology / Q000473:pathology; D013211:Staphylococcus aureus / Q000302:isolation & purification; D013297:Streptococcus pyogenes / Q000302:isolation & purification; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D019086:Bridged Bicyclo Compounds, Heterocyclic; D004224:Diterpenes; D009824:Ointments; C508887:retapamulin; D005672:Fusidic Acid