Oral β-lactams applied to uncomplicated infections of skin and skin structures

https://doi.org/10.1016/j.diagmicrobio.2006.11.020Get rights and content

Abstract

Uncomplicated skin and skin structure infections (uSSSIs) include impetigo, erysipelas, folliculitis, simple abscesses, and cellulitis. Their common bacterial causative agents include Staphylococcus aureus and Streptococcus pyogenes. Current guidelines predate the widespread occurrences of methicillin-resistant S. aureus (MRSA) as a community-acquired pathogen and include dicloxacillin, cephalexin, erythromycin, clindamycin, and amoxicillin/clavulanic acid, all orally, or mupirocin ointment applied topically, for impetigo. For other uSSSI, recommendations are based on the probability of the infection being caused by MRSA. If methicillin-susceptible S. aureus (MSSA) are known or suspected, the oral agents recommended include clindamycin, dicloxacillin, cephalexin, doxycycline, minocycline, and trimethoprim–sulfamethoxazole (SXT). For MRSA, recommended oral agents are linezolid, clindamycin, doxycycline, minocycline, and SXT. Because community-acquired MRSA infections now predominate in patients with abscesses in the United States, agents recommended for MRSA should be used for this indication. Local susceptibility patterns should guide empiric therapy. However, no placebo-controlled trials of uSSSI are available, and the evidence used to generate these recommendations is based on comparative noninferiority studies, often with wide noninferiority margins and confidence intervals. The evidence used in developing current guidelines therefore has significant limitations. Further studies, such as superiority outcome studies, placebo-controlled studies, measurement of time to resolution, or other novel approaches, are needed to resolve these treatment dilemmas. Until such studies are performed, the best surrogate available for predicting clinical outcome is application of pharmacokinetic and pharmacodynamic principles; these describe in vivo drug behavior and allow determination of susceptibility breakpoints for predicting in vivo antimicrobial efficacy via attainment of antimicrobial targets.

Introduction

Skin infections vary in importance from relatively mild, shallow and localized-to-severe, and life threatening, leading to widely varying treatments. Many simple skin infections can be treated with locally applied topical antibacterial ointments; necrotizing or gangrenous infections, on the other hand, must be treated aggressively, often with intravenous antimicrobials and surgical intervention. This review will focus on uncomplicated skin and skin structure infections (uSSSIs) that can be treated with oral or topical antimicrobial agents.

Section snippets

Uncomplicated skin and skin structure infections

Among the most common uSSSIs are impetigo, erysipelas, folliculitis, simple abscesses, and cellulitis. The common causative bacterial pathogens of superficial infections include the staphylococci, particularly Staphylococcus aureus and coagulase-negative species (CoNS), and streptococci, such as Streptococcus pyogenes (group A β-hemolytic streptococci).

Impetigo most often affects children and can be highly contagious. It usually occurs around the nose and mouth, or on the hands and forearms,

Pathogens

As reviewed above, the primary causative agents of uSSSI are S. pyogenes and S. aureus, and empiric treatment should be directed toward these pathogens, unless demonstrated otherwise. Although both are Gram-positive cocci, differences in drug resistance patterns complicate empirical therapeutic choices. S. aureus is usually not treatable with penicillin because >90% are β-lactamase producers, and, with increasing methicillin resistance, it is decreasingly susceptible to the full β-lactam drug

Pharmacokinetics/pharmacodynamics

Determining drug efficacy has historically been assessed using in vitro activity, animal infection models, and clinical studies. Human clinical trial studies, however, have significant limitations, particularly for diseases with high rates of spontaneous resolution, or where the effect of treatment is in improving time to disease resolution (Craig, 1998). The background rate of spontaneous resolution provides misleading data on actual cure rates with any antimicrobial agent (Marchant et al.,

Amoxicillin and amoxicillin–clavulanate

Amoxicillin is a useful agent for treating streptococcal infections, whereas amoxicillin–clavulanate is a useful agent for treating methicillin-susceptible staphylococcal infections because the addition of the β-lactamase inhibitor, clavulanate, inhibits staphylococcal β-lactamase. These agents diffuse readily into most body tissues and fluids. Amoxicillin–clavulanate is indicated for treatment of β-lactamase–producing S. aureus, Escherichia coli, and Klebsiella spp. skin and soft tissue

Published treatment guidelines

Treatment guidelines often provide categories and grades, indicating both the strength of each recommendation and the quality of the evidence upon which the recommendation is based (Stevens et al., 2005). The strength of evidence in support of a particular treatment is given a letter grade of A through E, from good evidence for A to good evidence against E, with moderate for/against B and D, and poor evidence C as the intermediate categories. The quality of evidence is determined by source of

Clinical trials of uSSSI

Because treatment recommendations are supposed to be based on scientifically valid evidence-based conclusions, it is worthwhile to examine the underpinnings of the clinical trial study designs that contribute the various data points used in decision making in uSSSI. The randomized, double-blind, controlled clinical trial, with sample sizes providing adequate statistical power, is often considered the “gold standard” of objective evidence wherein the study agent is demonstrated to be superior to

Conclusions

Most of the β-lactam agents tested against uSSSI perform as well as comparators and many are recommended and/or approved for treatment of such infections. However, as is the case in many other infections, none of the clinical trials tested agents against a placebo control, making it impossible to determine the background rate of spontaneous resolution. Consequently, the agents and comparators may be performing as well as no treatment at all. An uncomplicated infection, almost by definition, is

References (74)

  • C.D. Marchant et al.

    Measuring the comparative efficacy of antibacterial agents for acute otitis media: the “Pollyanna phenomenon”

    J. Pediatr.

    (1992)
  • M.G. Page

    Anti-MRSA beta-lactams in development

    Curr. Opin. Pharmacol.

    (2006)
  • R.D. Powers

    Open trial of oral fleroxacin versus amoxicillin/clavulanate in the treatment of infections of skin and soft tissue

    Am. J. Med.

    (1993)
  • J.W. Smith et al.

    Comparison of oral fleroxacin with oral amoxicillin/clavulanate for treatment of skin and soft tissue infections

    Am. J. Med.

    (1993)
  • D.L. Stevens et al.

    Comparison of oral cefpodoxime proxetil and cefaclor in the treatment of skin and soft tissue infections

    Diagn. Microbiol. Infect. Dis.

    (1993)
  • K.J. Tack et al.

    Cefdinir versus cephalexin for the treatment of skin and skin-structure infections. The Cefdinir Adult Skin Infection Study Group

    Clin. Ther.

    (1998)
  • H. Tassler

    Comparative efficacy and safety of oral fleroxacin and amoxicillin/clavulanate potassium in skin and soft tissue infections

    Am. J. Med.

    (1993)
  • J.I. Alos et al.

    Significant increase in the prevalence of erythromycin-resistant, clindamycin- and miocamycin-susceptible (M phenotype) Streptococcus pyogenes in Spain

    J. Antimicrob. Chemother.

    (2003)
  • D.G. Altman

    Practical Statistics for Medical Research

    (1991)
  • A. Buxbaum et al.

    Comparative activity of telithromycin against typical community-acquired respiratory pathogens

    J. Antimicrob. Chemother.

    (2003)
  • E. Calderon-Jaimes et al.

    Epidemiology of drug resistance: the case of Staphylococcus aureus and coagulase-negative staphylococci infections

    Salud Publica Mex.

    (2002)
  • Ceclor
  • Ceftin
  • Cefzil
  • K.J. Christiansen et al.

    Antimicrobial activities of garenoxacin (BMS 284756) against Asia-Pacific region clinical isolates from the SENTRY Program, 1999 to 2001

    Antimicrob. Agents Chemother.

    (2004)
  • CLSI

    Clinical and Laboratory Standards Institute. M100-S16, Performance Standards for Antimicrobial Susceptibility Testing; Sixteenth Informational Supplement

    (2006)
  • P.F. Coll et al.

    Exogenous thymidine and reversal of the inhibitory effect of sulfamethoxazole–trimethoprim on streptococci

    Eur. J. Clin. Microbiol.

    (1984)
  • W.A. Craig

    Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men

    Clin. Infect. Dis.

    (1998)
  • G.L. Darmstadt

    Oral antibiotic therapy for uncomplicated bacterial skin infections in children

    Pediatr. Infect. Dis. J.

    (1997)
  • D.J. Diekema et al.

    Survey of infections due to Staphylococcus species: frequency of occurrence and antimicrobial susceptibility of isolates collected in the United States, Canada, Latin America, Europe, and the Western Pacific region for the SENTRY Antimicrobial Surveillance Program, 1997–1999

    Clin. Infect. Dis.

    (2001)
  • Duricef
  • Duricef Package Insert
    (2005)
  • S.S. Ellenberg et al.

    Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: Practical issues and specific cases

    Ann. Intern. Med.

    (2000)
  • EMEA

    Committee for Medicinal Products for Human Use (CHMP): guideline on the choice of the non-inferiority margin

  • G.R. Fleisher et al.

    Amoxicillin combined with clavulanic acid for the treatment of soft tissue infections in children

    Antimicrob. Agents Chemother.

    (1983)
  • T.R. Fritsche et al.

    Importance of understanding pharmacokinetic/pharmacodynamic principles in the emergence of resistances, including community-associated Staphylococcus aureus

    J. Durgs Dermatol.

    (2005)
  • P.A. Giordano et al.

    Cefdinir versus cephalexin for mild to moderate uncomplicated skin and skin structure infections in adolescents and adults

    Curr. Med. Res. Opin.

    (2006)
  • Cited by (0)

    View full text