Ebola Virus Disease: The Future Challenge and Promise of Providing Safe Quality Care

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1 Ebola Virus Disease: The Future Challenge and Promise of Providing Safe Quality Care Daniel Bausch, MD, MPH&TM Technical Lead Epidemic Clinical Management Team WHO Geneva 6 th FIDSSA Congress 2015 Drakensberg, South Africa November 5, Contact: bauschd@who.int

2 Ebola Treatment Units

3 CDC

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6 Best Clinical Management Practices? What fluid and electrolyte support? Anti-diarrheal agents? Antibiotic prophylaxis? Blood products/immune therapy? Antiviral agents?

7 Imported/Repatriated Cases of Ebola Virus Disease ( ) Ebola cases in USA and Europe 21 MEDEVAC DEU 4 FRA 2 ITA 1 NET 2 NOR 1 SPA 4 SWI 1 UK 1 USA 5 Senegal Mali Guinea Nigeria Sierra Leone Liberia CFR in Africa: 40-60% RDC CFR in Europe and North America < 20% Pandemic and Epidemic Diseases department

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10 EDCARN Emerging Disease Clinical Assessment and Response Network Clinical & Infection Control Pandemic & Epidemic Diseases WHO-HQ, Geneva

11 EDCARN Mission Provide support to first-line responders through rapid development of evidence-based, country-adapted standardized approaches and protocols for patient management and systematic and standardized data collection on EIDs in order to establish best practices, identify key knowledge gaps, and pursue solutions Rapidly deploy international experts to provide technical guidance Provide a platform for discussion, information exchange and learning Coordinate preparation of clinical guidelines and training materials Coordinate and conduct training of national and international clinicians and researchers Promote establishment of central data repositories for clinical and associated data, with subsequent analysis 11

12 EDCARN Partner mapping Network (InFact) Network (ISARIC) Network (SCC) WHO ERC WHO Secretariat Disease / initiatives Specific Advisory Panel Network (WFICCS) Ministry of Health WHO CC Clinical trials WHO CC Preclinical research WHO CC Training of EID Clinical management and clinical research WHO CC Systematic reviews 12

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14 WHO Deployments for Case Management and IPC (~70)

15 GI loss from diarrhea and vomiting: quantify input and output administer fluids aggressively to keep up with losses Electrolyte abnormalities (from GI losses): bedside monitoring (e.g., I-STAT) oral rehydration salts K+, glucose, HCO3- May be proximate cause of death (arrhythmia, cardiac arrest, seizure) Septic shock physiology: aggressive fluids (but monitor for vascular leak/pulmonary edema) Symptomatic management of nausea, vomiting, diarrhoea, seizures, myalgia, abdominal pain Prophylactic antibiotic use for possible gut translocation

16 16 Pre-positioned clinical research agreements/protocols

17 EVD Therapeutics Update Agent Source Outcome in EVD Conv. plasma Generic Clinical trials ongoing ZMapp Mapp Bio Clinical trial ongoing Favipiravir Toyama/Fuji Clinical trial ongoing Brincidofovir Chimerix Clinical trial stopped TKM-Ebola Tekmira Clinical trial ongoing BCX-4430 Biocryst Phase 1 Interferon- 1a Biogen Clinical trial ongoing AVI-7537 Sarepta Phase 1 FX-06 F4 Pharma Use in EVD cases rnapc2 ARCA Biophar Not used to date Pandemic and Epidemic Diseases department

18 Ethical Considerations for Clinical Research During Outbreaks IRB Approval To placebo or not placebo? Diversion of labor from outbreak response/patient care to research Pandemic and Epidemic Diseases department

19 Ebola virus infections in HCWs 3.4% of all EVD cases during the outbreak Country Cases Deaths Guinea Liberia Sierra Leone Total Data are confirmed cases and deaths only, apart from deaths in Sierra Leone, which include confirmed, probable, and suspected deaths. *Data as of 17 February. Pandemic and Epidemic Diseases department

20 Personal Protective Equipment

21 WHO Guideline Development Group on Personal Protective Equipment in the Context of Filovirus Disease Outbreak (Geneva, 6-7 October 2014) Pandemic and Epidemic Diseases department

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24 Evacuation and Care of Research Staff

25 What do you need to collect clinical data? Motivation/rationale Culture of systematic inquiry/research Sufficient resources Labor (many have overlapping/conflicting duties) Clinical support (Ultrasound, EKG, etc.) Laboratory support (assays, cold chain) Safe working environment (gloves, PPE, etc.) Pandemic and Epidemic Diseases department

26 International support can help but: Often arrive late to the outbreak Still limited labor pool Traditionally focus was on epidemiology and outbreak control, not patient care International clinicians also often not seasoned in systematic data collection/research Often no standards for what data to be collected or how patient should be treated, resulting in fragmented/uninterpretable data sets Pandemic and Epidemic Diseases department

27 Trained labor pool for clinical research, national and international

28 SARS Pandemic and Epidemic Diseases department

29 American Society of Tropical Medicine and Hygiene November 13-17, 2016 Atlanta, Georgia, USA Photo: TripAdvisor

30 Tribute to Fallen Healthcare Workers