New antibiotics against Gram-positive pathogens for acute bacterial skin and skin-structure...

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New antibiotics against Gram-positive pathogens for acute bacterial skin and skin- structure infections (ABSSSIs) 3 international, multi-centre, double-blind, randomised, controlled, non-inferiority studies: 1 Moran GJ et al. Lancet Infect Dis 2014;14:696-705; 2 Boucher HW et al. New Engl J Med 2014;370:2169-79; 3 Corey GR et al. New Engl J Med 2014;370:2180-90 1 of 3 * VCA dose: 1 g or 15 mg/kg body weight; EP: endpoint; ITT: intention-to-treat; NI: not indicated; Tx: treatment; VCA: vancomycin

Transcript of New antibiotics against Gram-positive pathogens for acute bacterial skin and skin-structure...

New antibiotics against Gram-positive pathogens for acute bacterial skin and skin-structure infections (ABSSSIs)

3 international, multi-centre, double-blind, randomised, controlled, non-inferiority studies:

1Moran GJ et al. Lancet Infect Dis 2014;14:696-705; 2Boucher HW et al. New Engl J Med 2014;370:2169-79; 3Corey GR et al. New Engl J Med 2014;370:2180-90

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*VCA dose: 1 g or 15 mg/kg body weight; EP: endpoint; ITT: intention-to-treat; NI: not indicated; Tx: treatment; VCA: vancomycin

New antibiotics against Gram-positive pathogens for acute bacterial skin and skin-structure infections (ABSSSIs)

1Moran GJ et al. Lancet Infect Dis 2014;14:696-705; 2Boucher HW et al. New Engl J Med 2014;370:2169-79; 3Corey GR et al. New Engl J Med 2014;370:2180-90

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†Definitions of early clinical response: Study 1: ≥20% reduction in lesion area at 48-72h vs baseline; Study 2: Cessation of spread of infection-related erythema and absence of fever at 48-72h; Study 3: Cessation of spreading or reduction in lesion size, absence of fever and no need for rescue antibiotic at 48-72h*Investigator-assessed clinical response at end of TxITT: intention-to-treat; MRSA: methicillin-resistant Staphylococcus aureus; NI: not indicated

New antibiotics against Gram-positive pathogens for acute bacterial skin and skin-structure infections (ABSSSIs)

Tedizolid, dalbavancin and oritavancin seem to be non-inferior to established Tx for ABSSSIs caused by Gram-positive pathogens

1Moran GJ et al. Lancet Infect Dis 2014;14:696-705; 2Boucher HW et al. New Engl J Med 2014;370:2169-79; 3Corey GR et al. New Engl J Med 2014;370:2180-90

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‡P<0.05; NI: not indicated; TEAE: treatment-emergent adverse event

Comparison of microbiology and antibiotic Tx between diabetics and non-diabetics hospitalised for acute bacterial skin and skin structure infection (ABSSSIs)

• Secondary analysis of 2 retrospective cohort studies in 7 hospitals (Colorado, USA): N=770 adult pts hospitalised for uncomplicated cellulitis or abscess (NOT involving an infected ulcer or deep tissue infection)

Jenkins T. IDWeek 2014 abs. 674

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Data from poster

DM: diabetes mellitus; NS: not significant

Comparison of microbiology and antibiotic Tx between diabetics and non-diabetics hospitalised for acute bacterial skin and skin structure infection (ABSSSIs)

• Multivariable logistic regression:

DM is independent prognostic factor for exposure to ≥2 days of broad Gram-negative Tx: OR=1.69; 95% CI:1.15-2.49

Although DM pts were not more likely to have Gram-neg. pathogens than non-DM pts, they were more likely to get broad Gram-neg. Tx

Jenkins T. IDWeek 2014 abs. 674

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Data from poster

Broad Gram-neg. Tx: fluoroquinolones, β-lactamase inhibitor combinations, carbapenems, 2nd-5th generation cephalosporins or aminoglycosides

Trimethoprim-sulfamethoxazole (TMP/SMX) vs placebo for incised and drained acute uncomplicated skin abscess

• Multi-centre, double-blind RCT in 5 emergency departments (USA): N=1,247 pts >12 yr (median age: 35 yr) with acute uncomplicated skin abscess (<1 wk; ≥2 cm diameter) receiving drainage + treated as outpatient

• Randomised to:

– Incision & drainage (I&D) (1/4 maximal dimension; min. 1 cm) + placebo

– I&D + TMP/SMX 80 mg/400 mg 4 tablets bid during 7 days

• Max. dimension of abscess cavity/associated erythema: median 2.5/6.5 cm

• Methicillin-resistant Staphylococcus aureus (MRSA): 44.3%• Primary endpoint: Clinical cure at test-of-cure (TOC) visit

(7-14 d after end of Tx)

Talan D. IDWeek 2014 abs. 1332

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Data from oral presentation

Trimethoprim-sulfamethoxazole (TMP/SMX) vs placebo for incised and drained acute uncomplicated skin abscess

Addition of TMP/SMX to I&D for skin abscesses may improve clinical cure rate 7-14 d after Tx, but the ≠ was not clinically significant

Talan D. IDWeek 2014 abs. 1332

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Data from oral presentation

*Mostly mild GI AEs