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.

Abstract

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).

DESIGN:

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

SETTING:

Patients recruited from 36 study centers in the United States.

PATIENTS:

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.

INTERVENTIONS:

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.

MAIN OUTCOME MEASURE:

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.

MAIN 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.

• Authors: Tonny Tanus, Nicole E Scangarella-Oman, Marybeth Dalessandro, Gang Li, John J Breton, John F Tomayko
• Journal: Advances in skin & wound care (Adv Skin Wound Care) Vol. 27 Issue 12 Pg. 548-59 (Dec 2014) ISSN: 1538-8654 [Electronic] United States
• PMID: 25396674 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Bridged Bicyclo Compounds, Heterocyclic
• Diterpenes
• Ointments
• retapamulin
• Linezolid

Topics

• Administration, Oral
• Administration, Topical
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anti-Bacterial Agents (administration & dosage)
• Bridged Bicyclo Compounds, Heterocyclic (administration & dosage)
• Child
• Child, Preschool
• Diterpenes
• Double-Blind Method
• Female
• Humans
• Impetigo (complications, drug therapy, microbiology)
• Infant
• Infant, Newborn
• Linezolid (administration & dosage)
• Male
• Methicillin-Resistant Staphylococcus aureus (drug effects)
• Middle Aged
• Ointments (administration & dosage)
• Staphylococcal Skin Infections (complications, drug therapy, microbiology)
• Treatment Outcome
• Wounds and Injuries (complications, drug therapy, microbiology)
• Young Adult