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.
Adv Skin Wound Care
; 27(12): 548-59, 2014 Dec.
Article
em En
| MEDLINE
| ID: mdl-25396674
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Ferimentos e Lesões
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Infecções Cutâneas Estafilocócicas
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Compostos Bicíclicos Heterocíclicos com Pontes
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Staphylococcus aureus Resistente à Meticilina
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Linezolida
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Impetigo
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Antibacterianos
Tipo de estudo:
Clinical_trials
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Guideline
Limite:
Adolescent
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Adult
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Aged
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Aged80
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Child
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Child, preschool
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Female
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Humans
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Infant
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Male
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article