Pharmacology and Treatment
Topical Retapamulin Ointment, 1%, versus Sodium Fusidate Ointment, 2%, for Impetigo: A Randomized, Observer-Blinded, Noninferiority StudyOranje A.P.a · Chosidow O.b · Sacchidanand S.c · Todd G.d · Singh K.e · Scangarella N.e · Shawar R.e · Twynholm M.f
aDepartment of Dermatology and Venereology (Pediatric Dermatology), Erasmus MC, University Medical Center/Sophia Children’s Hospital, Rotterdam, The Netherlands; bDepartment of Dermatology and Allergy, AP-HP, Université Pierre et Marie Curie, Hôpital Tenon, Paris, France; cDepartment of Dermatology and STD, Victoria Hospital, Bangalore, India; dDivision of Dermatology, University of Cape Town, Cape Town, South Africa; eGlaxoSmithKline, Collegeville, Pa., USA; fGlaxoSmithKline, Greenford, UK
Do you have an account?
- Rent for 48h to view
- Buy Cloud Access for unlimited viewing via different devices
- Synchronizing in the ReadCube Cloud
- Printing and saving restrictions apply
Rental: USD 8.50
Cloud: USD 20.00
Article / Publication Details
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 ≧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.
© 2007 S. Karger AG, Basel
- Sladden MJ, Johnston GA: Common skin infections in children. BMJ 2004;329:95–99.
- Brook I: Secondary bacterial infections complicating skin lesions. J Med Microbiol 2002;51:808–812.
- Roth RR, James WD: Microbiology of the skin: resident flora, ecology, infection. J Am Acad Dermatol 1989;20:367–390.
- Koning S, van der Wouden JC: Treatment for impetigo. BMJ 2004;329:695–696.
Koning S, Verhagen AP, van Suijlekom-Smit LW, Morris A, Butler CC, van der Wouden JC: Interventions for impetigo. Cochrane Database Syst Rev 2004;2:CD003261.
- Hahn RG, Knox LM, Forman TA: Evaluation of poststreptococcal illness. Am Fam Physician 2005;71:1949–1954.
Hunt E: Pleuromutilin antibiotics. Drugs Future 2000;25:1163–1168.
British National Formulary. London, BMJ Publishing Group and Royal Pharmaceutical Society of Great Britain, 2006.
- George A, Rubin G: A systematic review and meta-analysis of treatments for impetigo. Br J Gen Pract 2003;53:480–487.
- Pankuch GA, Lin G, Hoellman DB, Good CE, Jacobs MR, Appelbaum PC: Activity of retapamulin against Streptococcus pyogenes and Staphylococcus aureus evaluated by agar dilution, microdilution, E-test, and disk diffusion methodologies. Antimicrob Agents Chemother 2006;50:1727–1730.
- Kosowska-Shick K, Clark C, Credito K, McGhee P, Dewasse B, Bogdanovich T, Appelbaum PC: Single- and multistep resistance selection studies on the activity of retapamulin compared to other agents against Staphylococcus aureus and Streptococcus pyogenes. Antimicrob Agents Chemother 2006;50:765–769.
- Gentry DR, Rittenhouse SF, McCloskey L, Holmes DJ: Stepwise exposure of Staphylococcus aureus to pleuromutilins is associated with stepwise acquisition of mutations in rplC and minimally affects susceptibility to retapamulin. Antimicrob Agents Chemother 2007;51:2048–2052.
- Jones RN, Fritsche TR, Sader HS, Ross JE: Activity of retapamulin (SB-275833), a novel pleuromutilin, against selected resistant gram-positive cocci. Antimicrob Agents Chemother 2006;50:2583–2586.
- Free A, Roth E, Dalessandro M, Hirman J, Scangarella N, Shawar R, White S: Retapamulin ointment twice daily for 5 days vs oral cephalexin twice daily for 10 days for empiric treatment of secondarily infected traumatic lesions of the skin. Skin Med 2006;5:224–232.
- Parish LC, Jorizzo JL, Breton JJ, Hirman JW, Scangarella NE, Shawar RM, White SM: Topical retapamulin ointment (1%, wt/wt) twice daily for 5 days versusoral cephalexin twice daily for 10 days in the treatment of secondarily infected dermatitis: results of a randomized, controlled, trial. J Am Acad Dermatol 2006;55:1003–1013.
- Stevens DL, Bisno AL, Chambers HF, Everett ED, Dellinger P, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan EL, Montoya JG, Wade JC: Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis 2005;41:1373–1406.
- Breneman DL: Use of mupirocin ointment in the treatment of secondarily infected dermatoses. J Am Acad Dermatol 1990;22:886–892.
National Committee for Clinical Microbiology Standards: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Approved Standard (NCCLS Document M7-A6), ed 6. Wayne, NCCLS, 2003.
National Committee for Clinical Microbiology Standards: Performance Standards for Antimicrobial Susceptibility Testing – Thirteenth Informational Supplement (NCCLS Document M100-S13, M7). Wayne, NCCLS, 2003.
- Koning S, van Suijlekom-Smit L, Nouwen J, Verduin C, Bernsen R, Oranje A, Thomas S, van der Wouden J: Fusidic acid cream in the treatment of impetigo in general practice: double blind randomised placebo controlled trial. BMJ 2002;324:203–206.
- Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ: Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006;295:1152–1160.
- Shah M, Mohanraj M: High levels of fusidic acid-resistant Staphylococcusaureus in dermatology patients. Br J Dermatol 2003;148:1018–1020.
- Chosidow O, Bernard P, Berbis P, Humbert P, Crickx B, Jarlier V: Cloxacillin versus pristinamycin for superficial pyodermas: a randomized, open-label, non-inferiority study. Dermatology 2005;210:370–374.
- del Giudice P, Chosidow O: Superficial pyodermas: advances, recommendations and needs. Dermatology 2005;210:367–369.
- Chosidow O, Maurette C, Dupuy P: Randomized, open-labeled, non-inferiority study between ciclopiroxolamine 1% cream and ketoconazole 2% foaming gel in mild to moderate facial seborrheic dermatitis. Dermatology 2003;206:233–240.
- Dupuy P, Maurette C, Amoric JC, Chosidow O: Randomized, placebo-controlled, double-blind study on clinical efficacy of ciclopiroxolamine 1% cream in facial seborrhoeic dermatitis. Br J Dermatol 2001;144:1033–1037.
- Sladden MJ, Johnston GA: More common skin infections in children. BMJ 2005;330:1194–1198.
- Gagliotti C, Nobilio L, Milandri M, Moro ML: Macrolide prescriptions and erythromycin resistance of Streptococcus pyogenes. Clin Infect Dis 2006;42:1153–1156.
- Littauer P, Caugant DA, Sangvik M, Hoiby EA, Sundsfjord A, Simonsen GS: Macrolide-resistant Streptococcus pyogenes in Norway: population structure and resistance determinants. Antimicrob Agents Chemother 2006;50:1896–1899.
- Noguchi N, Nakaminami H, Nishijima S, Kurokawa I, So H, Sasatsu M: Antimicrobial agent of susceptibilities and antiseptic resistance gene distribution among methicillin-resistant Staphylococcus aureus isolates from patients with impetigo and staphylococcal scalded skin syndrome. J Clin Microbiol 2006;44:2119–2125.
- Sabol KE, Echevarria KL, Lewis JS 2nd: Community-associated methicillin-resistant Staphylococcus aureus: new bug, old drugs. Ann Pharmacother 2006;40:1125–1133.
- Silva-Costa C, Ramirez M, Melo-Cristino J: Identification of macrolide-resistant clones of Streptococcus pyogenes in Portugal. Clin Microbiol Infect 2006;12:513–518.
- Saied GM: Microbial pattern and antimicrobial resistance, a surgeon’s perspective: retrospective study in surgical wards and seven intensive-care units in two university hospitals in Cairo, Egypt. Dermatology 2006;212:8–14.
- Afset JE, Maeland JA: Susceptibility of skin and soft-tissue isolates of Staphylococcus aureus and Streptococcus pyogenes to topical antibiotics: indications of clonal spread of fusidic acid-resistant Staphylococcus aureus. Scand J Infect Dis 2003;35:84–89.
Article / Publication Details
Copyright / Drug Dosage / DisclaimerCopyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.