Gram-Positive Infections and OPAT:

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1 Gram-Positive Infections and OPAT: Developments and Observations R. Andrew Seaton Gartnavel General Hospital Glasgow, Scotland, UK The views presented are the views of the speaker and not necessarily the views of Novartis

2 Disclosures Honoraria and educational grants received for presentations, investigator initiated studies and advisory boards (Novartis, Pfizer) Principle investigator (recent/current): DAP 002 (Cubist, Novartis) DAP-OST (Cubist) EU-CORE (Novartis)

3 The burden of inpatient i.v. antibiotic therapy 1/3 hospital admissions receive antibiotic treatment 1 1/10 receive i.v. antibiotics ~24,000 per million population/yr All specialties Integrated part of hospital care Necessitate hospital admission Prolong admission Some could be discharged if they do not require i.v. antibiotic therapy 2 Deep-seated 9% Infection types in acute admissions receiving i.v. antibiotics (n=381) 1 Unknown 9% Other 5% IAI 14% Not documented 4% SSTI 16% UTI 7% RTI 36% 1. Seaton RA et al. Int J Antimicrob Agents 2007;29: McLaughlin C et al. Q J Med 2005;98:

4 Outpatient parenteral antimicrobial therapy (OPAT) Parenteral (i.v. or i.m.) antimicrobial administered on different days without an overnight hospital stay 12 1,2 If no oral agent available or appropriate Assures absorption, compliance and rapid achievement of therapeutic concentrations Proven effectiveness in: 1 Osteomyelitis SSTIs Endocarditis Meningitis 1. Tice AD et al. Clin Infect Dis 2004;38: Buxton ILO. In: Goodman & Gilman s The Pharmacological Basis of Therapeutics 11th edn. Brunton LL et al. (editors). 2006;1 39

5 OPAT: most common indications and pathogens Proportio on of all diagnos ses, % OPAT outcomes registry Pathog gens recov vered, % of total Tice AD et al. Clin Infect Dis 2004;38:

6 OPAT* in clinical trials: Complicated S. aureus bacteraemia 52% received OPAT (mean 14.9 days (1-49)) Proport ion of patients, % MRSA 41 P< P=0.061 IE P< OPAT (n=103) IPAT (n=97) P= Completed Successs Deaths Readmission SAE Rehm S et al. J Antimicrob Chemother 2009;63: ***Daptomycin or vancomycin or semi-synthetic penicillin

7 Phase IV studies: OPAT Daptomycin experience in CORE Clinical success rates for daptomycin OPAT or IPAT P=0.005 P<0.001 P<0.001 n=14 n=15 n=73 n=143 n=177 n=123 n=275 n=129 n=539 n=410 IE (n=29) Bacteraemia (n=216) cssti (n=300) Other (n=404) All (n=949) Martone W et al. Int J Clin Pract 2008;62: Cubicin Outcomes Registry and Experience (CORE ) a retrospective chart review of patients who have received daptomycin

8 Glasgow OPAT service Developed from 2000 onward ID led with team approach Clinical i l links Emergency department Diabetic clinic Orthopaedics i.v. admin: nurse or patient/carer Prospectively maintained database

9 Infections treated with OPAT in Glasgow Nu umber of patients Diagnoses for OPAT patients (n=2477) 350 Other BJI SSTI * Year *data to June Seaton RA. Unpublished data

10 Antibiotic agents used for OPAT Most frequently used antibiotic agents for OPAT (2279 episodes) 29% Ceftriaxone Teicoplanin Penicillin Daptomycin Ertapenem Amikacin Flucloxacillin Meropenem Pip-Taz Other 64% Seaton RA. Unpublished data

11 Teicoplanin in OPAT Indications 1 Resistant staphylococcal infections (CoNS or MRSA) Gram-positive infections with β-lactam allergy Failure with β-lactams Dosing regimen 2 Loading: mg/kg for 3 days (inpatient or outpatient) Maintenance: 3 /week (butterfly) TDM at longest interval (72 hours) Target trough concentration for deep-seated infections: μg/ml <20 μg/ml: increase dose or reduce interval (alt. days) >30 μg/ml: reduce dose or increase interval (2 or 1 /week) 1. Sanofi-aventis. Targocid (teicoplanin) Summary of Product Characteristics Lamont E et al. J Antimicrob Chemother 2009;doi: /jac/dkp147

12 Skin and Soft Tissue Infection

13 Requires es IV Rx Surgery +/- HAI No Sepsis not Required Non-life Threatening Stable, Predictable Comorbidity Management Decisions i OPAT

14 OPAT treatment pathway for SSTIs: empiric antibiotic choice History of MRSA or Beta-lactam allergy? Yes Teicoplanin Clindamycin* *If Beta-lactam allergy or sensitive MRSA No Ceftriaxone Clindamycin or Flucloxacillin

15 Patient group direction for SSTIs Patient group : non-lifethreatening cellulitis amenable for home care and requiring i.v. therapy Uniform therapeutic management Suitable protocol in place Exclusions Prior physician review Indications for specialist review Indications for IVOST Trained, experienced staff Approved by ADTC IVOST, i.v. antibiotic oral switch therapy Seaton RA et al. J Antimicrob Chemother 2005;55:

16 OPAT for cellulitis Propor rtion of pat tients, % Comparison of patients pre- and post-introduction of a nurse-led management protocol Pre-intervention (n=230) Post-intervention (n=112) Cure/ Re- Drug Surgery Medical improved admission reaction review Switch Protocol management was associated with reduced duration of outpatient i.v. therapy (from 4 to 3 days, P=0.02) Seaton RA et al. J Antimicrob Chemother 2005;55:

17 Characteristics of 963 patients with OPAT managed SSTI Table 1. Patient baseline characteristics Median age in years (IQR ) 48 (37-64) Sex = female % Penicillin allergy % Referred from community (GP or Emergency department) % MRSA infection % Diabetes 85 88% 8.8% Vascular disease % Immunocompromised % Infection type: Cellulitis/ erysipelas Bursitis, with or without cellulitis Wound infection Infected ulcer Other % 3.0% 2.7% 0.8% 3.1% Managed via a nurse-led patient group direction % Seaton RA et al, P1333, 20th ECCMID 2010: Vienna, Austria.

18 Median duration of OPAT (days) OPAT (days) Duration of Linear time trend in log (OPAT days) 10 Estmate ( ) p< Year Seaton RA et al, P1333, 20th ECCMID 2010: Vienna, Austria.

19 Outcome of therapy by Primary OPAT Antibiotic Table 2. Outcome of therapy by primary OPAT antibiotic Outcome Ceftriaxone Teicoplanin All (n=811) (n=144) (n=963) Duration of OPAT in days 3 (2-4) 8 (3-12) 3 (2-5) (IQR*) Readmission 43 (5.3%) 15 (10.4%) 58 (6.0%) Significant adverse event 45 (5.5%) 21 (14.6%) 68 (7.1%) Progression of infection 21 (2.6%) 6 (4.2%) 27 (2.8%) OPAT failure* 85 (10.5%) 37 (25.7%) 124 (12.9%) *Switch of antibiotic, progression of infection or re-admission Seaton RA et al, P1333, 20th ECCMID 2010: Vienna, Austria.

20 Factors Associated with OPAT Failure (Switch of antibiotic, progression of infection or readmission) Univariate logistic regression Multiple logistic regression Variable OR (95% CI) P value OR (95% CI) P value Age (per additional 10 yrs) 1.13 (1.01, 1.25) Gender = female 1.69 (1.15, 2.48) ( ) MRSA 3.63(1.90, 6.94) < Diabetes 2.26 (1.30, 3.92) ( ) Teicoplanin vs Ceftriaxone 2.95 (1.91, 4.57) < ( ) Seaton RA et al, P1333, 20th ECCMID 2010: Vienna, Austria.

21 Factors Associated with increase in duration of OPAT Multiple linear regression Variable Estimate* (95% CI) P value Age (per additional 10 years) 1.03 ( ) MRSA 1.47 ( ) Vascular disease 1.29 ( ) Teicoplanin vs Ceftriaxone 1.32( ) 16-1 < Referred from community 0.91 ( ) Managed via PGD 0.71 ( ) < Infection type Bursitis vs cellulitis 1.81 ( ) < Wound infection vs cellulitis 1.74 ( ) Other infection vs cellulitis 1.25 (1.00, 1.56) * Estimates: percentage change in number of days in OPAT: for example, an estimate of 1.10 means that, on average, a variable is associated with a 10% increase in the number of days of treatment. Seaton RA et al, P1333, 20th ECCMID 2010: Vienna, Austria.

22 Bone and joint Infection

23 OPAT for Bone and Joint Infections: Experience from a UK Teaching Hospital-based service 564 episodes Rx via OPAT first patient episodes % positive microbiology 86% Gram +ve 51% Meticillin resistant Initial antibiotic therapy 30 PKI % Teicoplanin 5 26% Ceftriaxone 0 DFI OM PHI MWI 10 VOM Nature of Infection SA Mackintosh CL, White HA and Seaton RA, JAC (in press)

24 Definition of OPAT Failure in BJI When the prescribed OPAT course was not successful in eliciting either a cure or major improvement Continuation of IV Rx beyond the original course Unanticipated surgery Readmission or interruption of OPAT Rx Relapse or recurrence of infection Early Failure: within 4 weeks of discontinuation Late Failure: beyond 4 weeks or died during follow up Mackintosh CL, White HA and Seaton RA, JAC (in press)

25 Kaplan-Meier survival estimate of time to treatment failure for all patients per diagnosis MWI VOM SA PK/PH/OM DFI analysis time (weeks) Mackintosh CL, White H.A, and Seaton R.A, JAC (in press)

26 Multivariate odds ratio of failing initial OPAT therapy Odds Ratio 95% C. I. P Diabetic foot infection MRSA infection CoNS/Diptheroids yrs MRSA + mixed Goodness of fit: log likelihood -66.5, r P= Mackintosh CL, White H.A, and Seaton R.A, JAC (in press)

27 Multivariate Cox regression model of significant factors from univariate analysis showing association with treatment failure over the follow-up period Hazard Ratio 95% C. I. P MRSA infection Diabetic foot infection < years Goodness of fit: log likelihood , X , P< Mackintosh CL, White H.A, and Seaton R.A, JAC (in press)

28 Endocarditis

29 OPAT Managed Endocarditis Results 63 episodes for 59 patients Median age 64 (54 72) 44% prosthetic ordevice relatedrelated 94% Left sided 49% home eadministered ed OPAT Mean OPAT days bed days saved C. Duncan et al, FIS, Edinburgh 2010, Poster

30 Risk Factors for OPAT failure (P<0.05) Univariate Logistic regression Haemodialysis Nil Chronic renal failure CRP at beginning of OPAT OPAT via Hickman line C. Duncan et al, FIS, Edinburgh 2010, Poster

31 OPAT: future prospects and challenges Development potential depends on: Local economics and clinical needs Emergency medicine (SSTI, home) Oncology Cardiothoracic Minimizing i i i risks of HAI (CRBSI) (Endovascular) Alignment with other developing ambulatory care facilities Risk management and communication Cost-efficiency: logistics/funding, geography, politics and legal issues

32 Summary OPAT is safe and effective for a wide variety of Gram-positive infections in selected patients in UK Teicoplanin Rx is an independent risk factors for OPAT failure and prolongation of Rx in SSTI Female sex, diabetes, older age, vascular disease, diagnosis other than cellulitis, initial hospitalisation and MRSA infection associated with more complicated OPAT course in SSTI Reduced duration of therapy associated with management via PGD Independent risk factors for OPAT failure in BJI are Older age, MRSA infection and diabetic foot infection Early failure also in CNS/Diphtheroid infections Increasing utility of OPAT in management of Endocarditis

33 Conclusions As experience with OPAT grows in more complex patient groups, patient and infection- specific factors are emerging which may help predict success or failure of therapy Understanding of these factors may help guide patient selection (for OPAT) or refine treatment choices within OPAT

34 Acknowledgements Claire MacKintosh, Helena White, Chris Duncan,,,, Lindsay Semple, Emma Bell, Elspeth Lamont and Chris Weir

35 Infections treated with OPAT in Glasgow Nu umber of patients 100% Other 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Diagnoses for OPAT patients (n=2477) 80% SSTI Year * BJI *data to June Seaton RA. Unpublished data

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