A randomized, double-blind, comparative study to assess the safety and efficacy of topical retapamulin ointment 1% versus oral linezolid in the treatment of secondarily infected traumatic lesions and impetigo due to methicillin-resistant Staphylococcus aureus.
OBJECTIVE
To evaluate the clinical and bacteriological efficacy of topical retapamulin ointment 1% versus oral linezolid in the treatment of patients with secondarily infected traumatic lesions (SITLs; excluding abscesses) or impetigo due to methicillin-resistant Staphylococcus aureus (MRSA).


METHODS
A randomized, double-blind, double-dummy, multicenter, comparative study (NCT00852540).


METHODS
Patients recruited from 36 study centers in the United States.


METHODS
Patients 2 months or older with SITL (including secondarily infected lacerations or sutured wounds) or impetigo (bullous and nonbullous) suitable for treatment with a topical antibiotic, with a total Skin Infection Rating Scale score of 8 or greater, including a pus/exudate score of 3 or greater.


METHODS
Patients received retapamulin ointment 1% (plus oral placebo), twice daily for 5 days or oral linezolid (plus placebo ointment) 2 or 3 times daily for 10 days.


METHODS
Primary end point: clinical response (success/failure) at follow-up in patients with MRSA at baseline (per-protocol population). Secondary efficacy end points: clinical and microbiologic response and outcome at follow-up and end of therapy; therapeutic response at follow-up.


RESULTS
The majority of patients had SITL (70.4% [188/267] and 66.4% [91/137] in the retapamulin and linezolid groups, respectively; intent-to-treat clinical population). Clinical success rate at follow-up was significantly lower in the retapamulin versus the linezolid group (63.9% [39/61] vs 90.6% [29/32], respectively; difference in success rate -26.7%; 95% CI, -45.7 to -7.7).


CONCLUSIONS
Clinical success rate at follow-up in the per-protocol MRSA population was significantly lower in the retapamulin versus the linezolid group. It could not be determined whether this was related to study design, bacterial virulence, or retapamulin activity.
Tonny Tanus, MD, is Director, Kern Allergy Medical Clinic Inc, Bakersfield, California, and Assistant Clinical Professor, David Geffen School of Medicine, University of California, Los Angeles. Nicole E. Scangarella-Oman, MS, is an Investigator; Marybeth Dalessandro, BS, is Manager, Clinical Development; Gang Li, PhD, is Manager, Statistics; John J. Breton, MCM, is Manager, Clinical Development; and John F. Tomayko, MD, is Senior Director, all in the Department of Infectious Diseases Medicines Discovery and Development, GlaxoSmithKline, Collegeville, Pennsylvania. The authors disclose they will discuss off-label uses of retapamulin 1% (Altabax, Altargo). Dr Tanus has disclosed that he is/was a recipient of grant/research funding from Stiefel/GlaxoSmithKline, Amgen, and Genentech; he is a recipient of grant/research funding from Teva Pharmaceuticals; and he was a member of the speakers' bureau for Astra Zeneca. The coauthors have disclosed they are employees of GlaxoSmithKline. Ms Scangarella-Oman, Ms Dalessandro, Mr Breton, and Dr Tomayko have disclosed they are stock shareholders of GlaxoSmithKline. The authors disclose that the study was supported by funding from GlaxoSmithKline.
Tonny
T
Tanus
Nicole E
NE
Scangarella-Oman
Marybeth
M
Dalessandro
Gang
G
Li
John J
JJ
Breton
John F
JF
Tomayko
D000284:Administration, Oral; 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; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007169:Impetigo / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D007223:Infant; D007231:Infant, Newborn; D000069349:Linezolid / Q000008:administration & dosage*; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus / Q000187:drug effects*; D008875:Middle Aged; D009824:Ointments / Q000008:administration & dosage; D013207:Staphylococcal Skin Infections / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome; D014947:Wounds and Injuries / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D055815:Young Adult
D000900:Anti-Bacterial Agents; D019086:Bridged Bicyclo Compounds, Heterocyclic; D004224:Diterpenes; D009824:Ointments; C508887:retapamulin; D000069349:Linezolid