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2013 ANTIMICROBIAL UPDATE OKLAHOMA ACP CHAPTER OCTOBER 18, 2013 MICHELLE R. SALVAGGIO MD FACP ASSOCIATE PROFESSOR, MEDICINE SECTION OF INFECTIOUS DISEASES.

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Presentation on theme: "2013 ANTIMICROBIAL UPDATE OKLAHOMA ACP CHAPTER OCTOBER 18, 2013 MICHELLE R. SALVAGGIO MD FACP ASSOCIATE PROFESSOR, MEDICINE SECTION OF INFECTIOUS DISEASES."— Presentation transcript:

1 2013 ANTIMICROBIAL UPDATE OKLAHOMA ACP CHAPTER OCTOBER 18, 2013 MICHELLE R. SALVAGGIO MD FACP ASSOCIATE PROFESSOR, MEDICINE SECTION OF INFECTIOUS DISEASES OUHSC

2 OUTLINE Clostridium difficile Methicillin resistant Staphylococcus aureus Hepatitis C HIV I will be discussing off-label use of some medications.

3 QUESTION 1 A 66 yo WM was recently admitted to the hospital for pneumonia. While admitted he was also diagnosed with C difficile diarrhea and has now completed a course of metronidazole. He is calling your office complaining of continued diarrhea. What do you do? A.Tell him take a probiotic and Immodium. B.Have him come to the office and submit stool for testing. C.Retreat with an extended course of metronidazole. D.Ask him if he has money saved, if he says yes, prescribe oral vancomycin. E.Call your GI colleague and arrange for fecal transplantation.

4 C. DIFFICILE BACKGROUND Gram-positive, anaerobic, spore- forming bacillus (“Difficile” because it is difficult to culture) Accounts for 20-30% cases of antibiotic-Major cause of hospital infection, morbidity and mortality. Present epidemic strain (BI/NAP1/027)first reported in the US in 2005 Now reported from 40 US states and all Canadian providences Comprises 36% of all C difficile infection (CDI) associated Rates continue to increase in North America Gerding D Infect Control Hosp Epidemiol 2010; 31(S1):S32-S34

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6 CDI CLINICAL MANIFESTATIONS Range from symptomless carriage to fatal pseudomembranous colitis 96% have received antibiotics within the previous 14 days Fever, abdominal cramps, peripheral leukocytosis, and hypoalbuminemia WBC can exceed 30,000-50,000 cells/mL and be indicative of severity Kelly CP and JT LaMont. NEJM 2008; 359: 1932-1940.

7 CDI TREATMENT Clinical definitionSupportive Clinical DataRecommended Treatment Initial episode, mild/moderateWBC ≤ 15K, Cr ≤ 1.5 x premorbid Metronidazole 500mg po tid, 10 – 14 days Initial episode, severeWBC ≥15K, Cr ≥1.5 x premorbid Vancomycin 125 mg po qid, 10 – 14 days Initial episode, severe, complicated Hypotension/shock, ileus, megacolon Vancomycin 500mg po/ngt qid + metronidazole 500mg iv q 8 hrs, consider pr vancomycin w ileus 1 st recurrenceSymptom drivenSame as initial episode 2 nd recurrenceSymptom drivenTaper or pulse vancomycin Adapted from Cohen et al. ICHE 2010; 31: 431-455 and Kelly CP. NEJM 2008; 359: 1932-1940.

8 FIDAXOMICIN (DIFICID) FDA approved in 2011: treatment of Clostridium difficile associated diarrhea Granted New Technology Add On-Payment by CMS (August 2012) Mechanism of action Bacteriocidal against C. dificile in vitro, inhibiting RNA synthesis by RNA polymerases Macrolide but does not confer cross-resistance Low rate of spontaneous resistance (although specific mutation Val-II43-Gly has been identified) Dificid Package Insert: http://www.dificid.com/sites/default/files/prescribing.pdf

9 FIDAXOMICIN FACTS Dose is 200mg po twice daily x 10 days Retail cost: $4000/course (cash) Very little systemic absorption, essentially no dose adjustment with various other medications, no adjustment with renal or hepatic impairment Warnings: hypersensitivity reaction (dyspnea, rash, pruritis, angioedema of mouth, throat, face), may report previous allergy to macrolides Adverse events/side effects: same rate of blood dyscrasias, GI symptoms (N/V/abd pain/GI bleed) as vancomycin Dificid Package Insert: http://www.dificid.com/sites/default/files/prescribing.pdf

10 FIDAXOMICIN DATA Two randomized, double-blinded controlled studies Non-inferiority design Fidaxomicin 200mg po BID vs vancomycin 125 mg po qid x 10 days in patients with CDAD Dificid Package Insert: http://www.dificid.com/sites/default/files/prescribing.pdf

11 OTHER CDAD TREATMENT OPTIONS Rifaximin - 400 mg BID for 14 days Nitazoxanide - 500mg BID for 7 – 10 days Fecal transplant - successful in uncontrolled series Monoclonal antibodies - against toxins A&B Nontoxigenic C difficile 1. Kelly CP and JT LaMont. NEJM 2008; 359: 1932-1940. 2. Cohen et al. ICHE 2010; 31: 431-455.

12 QUESTION 2 In mid January, a 54 yo woman presents to the hospital with increasing shortness of breath, productive cough and fever. She was diagnosed with influenza 1 month prior and treated with oseltamivir. Her chest Xray is consistent with lobar pneumonia. Sputum is positive for gram positive cocci in pairs. What is the best course of action at this time? A.Give her another course of oseltamivir B.Prescribe linezolid and send her home. C.Do a chest CT with angiography to assess for PE. D.Admit her, start vancomycin, pip/tazo and cipro. E.You lost me at gram positive cocci…

13 CEFTAROLINE (TEFLARO) FDA approved 2010: treatment of acute bacterial skin and skin structure infections community acquired bacterial pneumonia Mechanism action: cephalosporin (β-lactam) prodrug bacteriocidal against S aureus due to affinity for PBP2a bacteriocidal against S pneumoniae due to affinity to PBP2x Teflaro Package Insert: http://www.frx.com/pi/teflaro_pi.pdf

14 CEFTAROLINE DOSING Dosing: 600mg IV every 12 hours to be infused over one hour Dosing in renal impairment: CrCl > 50ml/min no adjustment CrCl >30 to ≤ 50 ml/min 400mg IV every 12 hours CrCl ≥15 to ≤ 30ml/min 300mg IV every 12 hours ESRD including HD 200mg IV every 12 hours Ceftaroline is dialyzable and should be given after HD No dosing adjustment with hepatic disease Teflaro Package Insert: http://www.frx.com/pi/teflaro_pi.pdf

15 CEFTAROLINE WARNINGS Hypersensitivity reactions: to ceftaroline and to other β- lactams Cephalosporins Pencillins carbapenems C difficile associated diarrhea Direct Coombs’s test seroconversion Monitor for drug induced hemolytic anemia Teflaro Package Insert: http://www.frx.com/pi/teflaro_pi.pdf

16 CEFTAROLINE SPECTRUM OF ACTIVITY Gram positive: S aureus (MRSA, MSSA), Streptococcus species Gram negative: E coli, Klebsiella species, H influenzae (possibly Citrobacter, Enterobacter, Proteus) DOES NOT COVER Enterococcus (including VRE) Anaerobes Pseudomonas species Any ESBL, KPC, etc Teflaro Package Insert: http://www.frx.com/pi/teflaro_pi.pdf

17 CEFTAROLINE DATA – ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS Lesion size ≥ 75 cm 2 Major abscess with ≥ 5cm surrounding erythema Wound infection Deep/extensive cellulitis Teflaro Package Insert: http://www.frx.com/pi/teflaro_pi.pdf

18 CEFTAROLINE DATA- COMMUNITY ACQUIRED BACTERIAL PNEUMONIA 2 studies comparing ceftriaxone to ceftaroline 1 study allowed macrolide on first day, the other did not No MRSA allowed Teflaro Package Insert: http://www.frx.com/pi/teflaro_pi.pdf

19 QUESTION 3 A 62 yo WF presents to your clinic complaining of fatigue. She asks you test her for everything. You order A.TSH, B12, cbc, sed rate B.Vit D C.HIV, Hep C D.Nothing. She needs reassurance alone. E.Referral to therapist.

20 SCREENING FOR HEPATITIS C: RECOMMENDATIONS CDC Issued on May 18, 2012 USPSTF issued on June 25, 2013 Routine HCV screening for all adults born from 1945 through 1965 (currently aged 48 – 68). Numbers of diagnosed patients expected to double, possibly triple 1.http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6104a1.htm 2.http://www.uspreventiveservicestaskforce.org/uspstf12/hepc/hepcfinalrs.htm

21 SCREENING: IDENTIFYING ESTIMATED 170 MILLION PERSONS WITH HCV INFECTION WORLDWIDE World Health Organization. Wkly Epid Rec.1999;74:425-427. World Health Organization. Hepatitis C: Global Prevalence: Update. 2003. Farci P, et al. Semin Liver Dis. 2000;20:103-126. Wasley A, et al. Semin Liver Dis. 2000;20:1-16. Europe 8.9 million (1.03%) Americas 13.1 million (1.7%) Africa 31.9 million (5.3%) Western Pacific 62.2 million (3.9%) Eastern Mediterranean 21.3 million (4.6%) Southeast Asia 32.3 million (2.15%)

22 HCV OVERVIEW/EPIDEMIOLOGY “Silent Epidemic” - Approximately 3.9 million in the US 170 million globally HIV—1 million US Majority of patients in US have Genotype 1 (75%), few G2 and G3 G2—10-15%; Europe G3—4-6%; Australia G4—Middle East, Africa G5—South Africa G6—Hong Kong Predominant cause of chronic liver disease, HCC, and death in US; leading indication for liver transplant Transmission Blood Sexual contact Mother-to-child Six genotypes Response to treatment dependent on genotype Ghany MG et al. 2006. Hepatology 49: 1335-1374.

23 CLINICAL MANIFESTATIONS OF HEPATITIS C

24 TELAPREVIR (INCIVEK) BOCEPREVIR (VICTRELIS) FDA Approved 2011: treatment of Hepatitis C genotype 1 in adults with compensated liver disease including cirrhosis May be used in treatment naïve, those who have previously been treated with an interferon-based therapy including prior null responders, partial responders and relapsers only in combination with peginterferon and ribavirin Mechanism of action NS3/4A protease inhibitor Incivek Package Insert: http://pi.vrtx.com/files/uspi_telaprevir.pdf Victrelis Package Insert:http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf

25 DOSING TELAPREVIR Dose Standard—750mg orally every 8 hours weeks 1-12, with food, not low fat Response and prior response dictate course of peg-interferon and ribavirin (12 to 36 more weeks) Hepatic impairment No dose adjustment for mild impairment, Child-Pugh A (score 5-6) Renal impairment No dose adjustment for CrCl > 50 ml/min BOCEPREVIR Dose Week 1 -4 peginterferon and ribavirin then add boceprevir 800mg orally every 8 hours with meal or snack Response, prior response and disease stage dictate course of all 3 meds(total of 28 – 52 weeks) Hepatic impairment No dose adjustment for mild, moderate or severe impairment Renal Impairment No dose adjustment for renal impairment Peg-interferon has only been studied in adults with CrCl > 50ml/min and is approved for use in compensated cirrhosis only Incivek Package Insert: http://pi.vrtx.com/files/uspi_telaprevir.pdf Victrelis Package Insert:http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf

26 WARNINGS TELAPREVIR Adverse Effects Black box: rash (Stevens Johnson, DRESS, TEN) Anemia GI: nausea, vomiting, diarrhea, anorectal discomfort, dysgeusia Cost (30-day supply) Standard dose $18,350 With peg-interferon + ribavirin = $21,000 BOCEPREVIR Adverse Effects Anemia Neutropenia Dysgeusia Cost (30 day supply) Standard dose $4,600 With peg-interferon + ribavirin = $7000 Incivek Package Insert: http://pi.vrtx.com/files/uspi_telaprevir.pdf Victrelis Package Insert:http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf

27 TELAPREVIR AND BOCEPREVIR DRUG INTERACTIONS Antiarrythmics: lidocaine, flecainide, amiodarone, digoxin Antibacterials: clarithromycin Anticoagulants: warfarin Anticonvulsants: carbamazepine, phenytoin Antidepressants: escitalopram, trazodone Antifungals: itraconazole, posaconazole, voriconazole Antigout: colchicine Antimycobacterial: rifabutin Benzodiazepines: alprazolam, IV midazolam, zolpidem Calcium channel blockers: amlodipine, all others Corticosteroids: prednisone, nasal fluticasone/butesanide HMG co-reductase inhibitors: atorvastatin, all others Hormonal contraceptives: ethinyl estradiol Incivek Package Insert: http://pi.vrtx.com/files/uspi_telaprevir.pdf Victrelis Package Insert:http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf

28 SVR RATES WITH BOC OR TVR IN GENOTYPE 1 TREATMENT-NAIVE PATIENTS 0 20 40 60 80 100 SVR (%) PegIFN/RBVBOC or TVR + PegIFN/RBV 38-44 63-75 Poordad F, et al. N Engl J Med. 2011;364:1195-1206. Jacobson IM, et al. N Engl J Med. 2011;364:2405-2416.

29 SVR RATES WITH BOC OR TVR IN GT1 TREATMENT-EXPERIENCED PATIENTS 0 20 40 60 80 100 SVR (%) RelapsersPartial Responders 69-83 PegIFN + RBV Bacon BR, et al. N Engl J Med. 2011;364:1207-1217. Zeuzem S, et al. N Engl J Med. 2011;364:2417-2428. Vierling JM, et al. AASLD 2011. Abstract 931. Null Responders BOC or TVR + PegIFN + RBV 24-29 40-59 7-15 29-38 5

30 HEPATITIS C TREATMENT OPTIONS First-line therapy Genotype 1 Telaprevir or Boceprevir + Pegylated interferon/Ribavirin Genotypes 2/3 Pegylated interferon/Ribavirin Treatment Duration Response-guided therapy Not to be used in cirrhotic and/or null responders Determined by early virologic decline RVR—undetectable HCV RNA at week 4 eRVR—undetectable HCV RNA at weeks 4 and 12

31 QUESTION 4 A 28 yo man presents to your office. He states he has heard about a medicine that will keep him from getting HIV. He would like for you to prescribe that to him. You A.Refer him to Infectious Diseases. B.Ask him why he thinks he is going to be infected with HIV. C.Ask him if he is infected with HIV. D.Give him a package of condoms.

32 US NATIONAL HIV STRATEGY RELEASED JULY 2010 http://www.whitehouse.gov/files/documents/nhas-implementation.pdf

33 JULY 16, 2012 FDA approves first drug for reducing the risk of sexually acquired HIV infection Truvada™ is indicated in combination with safer sex practices for pre- exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults at high risk. Originally approved 2004 for use in combination with other antiretrovirals for the treatment of HIV-1 in adults and children > 12 years. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm

34 EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) FACTS Combination product of two different nucleoside analogs emtricitabine (200mg) and tenofovir (300mg) Given orally once daily (regardless of indication) Retail cost: $1500/month Dosing in renal impairment: CrCl ≥ 50ml/min no adjustment CrCl 30 – 49 one tablet every 48 hours CrCl < 30 should not be used (includes HD pts) Truvada Package Insert: https://www.gilead.com/~/media/Files/pdfs/medicines/hiv/truvada/truvada_pi.pdf

35 FTC/TDF BLACK BOX WARNINGS Lactic acidosis and severe hepatomegaly (including fatal cases) Severe exacerbations of hepatitis B have been reported in pts coinfected with hep B and HIV who discontinued FTC/TDF TRUVADA used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for a PrEP indication following undetected acute HIV-1 infection. Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed. Truvada Package Insert: https://www.gilead.com/~/media/Files/pdfs/medicines/hiv/truvada/truvada_pi.pdf

36 ACUTE ANTIRETROVIRAL SYNDROME Vanhems P, et al. 2002. JAIDS 31: 318- 321.

37 FTC/TDF ADVERSE EVENTS/WARNINGS New onset or worsening renal impairment Fanconi syndrome Avoid concurrent nephrotoxic agents Decreased in bone mineral density Redistribution/accumulation of body fat Side effects in HIV positive patients (in combination with other agents): diarrhea, nausea, rash Side effects in HIV-negative patients: no significant difference from placebo Truvada Package Insert: https://www.gilead.com/~/media/Files/pdfs/medicines/hiv/truvada/truvada_pi.pdf

38 FTC/TDF NPREP DATA iPrEx 2499 MSM International FTD/TDF v placebo TDF2 1216 HTXL men/women in Botswana FTC/TDF v placebo FEM-PrEP 2056 HTXL women in Kenya, Tanzania, S Africa FTC/TDF v placebo Partner’s 1458 HTXL couples in Kenya, Uganda FTC/TDF v TDF v placebo VOICE 2029 HTXL women in S Africa, Uganda, Zimbabwe FTC/TDF v TDF v placebo TDF gel v placebo gel Reduction in incidence of HIV infection 44% (CL 15 – 63, p= 0.005) Max 2.8 years Decreased rate of infection by 62.2% (study stopped early due to poor retention) Max 3.7 years No reduction in infection Reduction in infection 75% FTCTDF (CI 55-87, p <0.001), 67% TDF (CI 44-81, p <0.001) TDF oral and gel stopped early due 6% infection rate for both No reduction of infection with FTC/TDF

39 BEFORE MSMHeterosexual Document negative HIV antibody test immediately before stating PrEP Test for acute HIV infection if patient has symptoms consistent with acute HIV infection + – if the person reports unprotected sex with an HIV-positive person in the preceding month Determine if women are planning to become pregnant or are currently pregnant or breastfeeding Confirm that patient is at ongoing, very high risk for acquiring HIV infection Confirm that calculated Cockcroft-Gault is >60 mL/min Truvada REMS: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientshttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatients andProviders/UCM312304.pdf

40 MSMHeterosexual If any sexual partner is known to be HIV-infected, determine whether receiving ART; assist with linkage to care if not in care or not receiving ART Screen for Hep B, vaccinate if susceptible, treat if active regardless of PrEP Screen and treat as needed for STIs Disclose to women that safety for infants exposed during pregnancy is not fully assessed, but no harm has been reported Do not prescribe to women who are breastfeeding BEFORE Truvada REMS: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientshttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatients andProviders/UCM312304.pdf

41 MSMHeterosexual 1 tablet TDF/FTC daily 90 day supply renewable after HIV repeat testing For women confirm pregnancy test is negative or if pregnant informed about use of medication during pregnancy For active Hep B consider using TDF/FTC for treatment Provide risk-reduction and PrEP medication adherence counseling and condoms BEGINNING Truvada REMS: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientshttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatients andProviders/UCM312304.pdf

42 MSMHeterosexual Every 2-3 months perform HIV antibody test (or antibody/antigen test); document negative results At each f/u for women conduct pregnancy test, document, if pregnant discuss the continued use of PrEP and prenatal-care Evaluate and support PrEP medication adherence at each follow-up visit, more often if inconsistent adherence is identifies Every 2-3 months assess risk behaviors and provide risk-reduction counseling and condoms. assess STI symptoms and if present treat Every 6 months test for bacterial STI even if patient is asymptomatic and treat as needed 3 months after initiation, then yearly while on PrEP medication, check BUN and SCr 3 months after initiation, then every 6 months while on PrEP medication, check SCR and calculate CrCl FOLLOW-UP Truvada REMS: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientshttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatients andProviders/UCM312304.pdf

43 MSMHeterosexual Perform HIV test to confirm whether HIV infection has occurred If HIV positive, order and document results of resistance testing and establish linkage to HIV care If HIV negative, establish linkage to risk-reduction support services as indicated If active hepatitis B is diagnosed at initiation of PrEP consider appropriate medication for continued treatment of hepatitis B If pregnant, inform prenatal-care provider of TDF/FTC use in early pregnancy and coordinate care to maintain HIV prevention during pregnancy and breastfeeding DISCONTINUING Truvada REMS: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientshttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatients andProviders/UCM312304.pdf

44 QUESTION 1 A 66 yo WM was recently admitted to the hospital for pneumonia. While admitted he was also diagnosed with C difficile diarrhea and has now completed a course of metronidazole. He is calling your office complaining of continued diarrhea. What do you do? A.Tell him take a probiotic and Immodium. B.Have him come to the office and submit stool for testing. C.Retreat with an extended course of metronidazole. D.Ask him if he has money saved, if he says yes, prescribe fidaxomicin. E.Call your GI colleague and arrange for fecal transplantation.

45 QUESTION 2 In mid January, a 54 yo woman presents to hospital with increasing shortness of breath, productive cough and fever. She was diagnosed with influenza 1 month prior and treated with oseltamivir. Her chest Xray is consistent with lobar pneumonia. Sputum is positive for gram positive cocci in pairs. She takes paroxetine daily. What is the best course of action at this time? A.Give her a another course of oseltamivir B.Prescribe linezolid and send her home. C.Do a chest CT to assess for empyema. D.Admit her, start vancomycin, pip/tazo and cipro. E.Admit her, start ceftaroline.

46 QUESTION 3 A 62 yo WF presents to your clinic complaining of fatigue. She asks you test her for everything. You order A.TSH, B12, cbc, sed rate B.Vit D C.HIV, Hep C D.Nothing. She needs reassurance alone. E.Referral to therapist.

47 QUESTION 3B You test the patient from the previous question for Hepatitis C. Her Hep C IgG is positive, viral load is 600,000 and her genotype is 1a. Her US shows mild cirrhosis and her LFTs are 1.5 ULN. What is the next step in her management? A.Test for HIV, Hepatitis A and B and syphilis. B.Have her come back in 6 months and repeat testing. C.Schedule her for a liver biopsy. D.Refer her to ANYONE treating Hepatitis C. E.Start her on telaprevir with peg-interferon and ribivirin.

48 QUESTION 4 A 28 yo man presents to your office. He states he has heard about a medicine that will keep him from getting HIV. He would like for you to prescribe that to him. You A.Refer him to Infectious Diseases. B.Ask him why he thinks he is going to be infected with HIV. C.Ask him if he is infected with HIV. D.Give him a package of condoms. E.Prescribe FTC/TDF.

49 SUMMARY C difficile remains a serious health issue. Vancomycin and metronidazole remain the mainstays of therapy. Fidaxomicin (Dificid) is another treatment option. MRSA skin and lung infections remain a serious health issues. Ceftaroline (Teflaro) has been approved for SSTI and may be used in pneumonia. Ceftaroline = cefazolin + MRSA coverage Screen everyone for Hepatitis C. If ab positive, get viral load and genotype then send to specialist. Screen everyone for HIV. Encourage safe sex practices to all of your patients. If pre-exposure prophylaxis questions come up, send the patient to us.


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