Topical retapamulin ointment, 1%, versus sodium fusidate ointment, 2%, for impetigo: a randomized, observer-blinded, noninferiority study.

Abstract

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.

CONCLUSION:

Retapamulin is a highly effective and convenient new treatment option for impetigo, with efficacy against isolates resistant to existing therapies.

• Authors: Arnold P Oranje, Olivier Chosidow, Sarvajnamurthy Sacchidanand, Gail Todd, Krishan Singh, Nicole Scangarella, Ribhi Shawar, Monique Twynholm, TOC100224 Study Team
• Journal: Dermatology (Basel, Switzerland) (Dermatology) Vol. 215 Issue 4 Pg. 331-40 ( 2007) ISSN: 1421-9832 [Electronic] Switzerland
• PMID: 17911992 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: 2007 S. Karger AG, Basel

Chemical References

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

Topics

• Administration, Topical
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anti-Bacterial Agents (administration & dosage)
• Bridged Bicyclo Compounds, Heterocyclic (administration & dosage)
• Child
• Child, Preschool
• Diterpenes
• Dose-Response Relationship, Drug
• Female
• Follow-Up Studies
• Fusidic Acid (administration & dosage)
• Humans
• Impetigo (drug therapy, microbiology, pathology)
• Infant
• Infant, Newborn
• Male
• Middle Aged
• Ointments
• Single-Blind Method
• Skin (microbiology, pathology)
• Staphylococcus aureus (isolation & purification)
• Streptococcus pyogenes (isolation & purification)
• Treatment Outcome