The INMI experience for the Ebola
response in Africa and in Europe and
patients’ management
Giuseppe Ippolito on behalf of INMI’s VHFs response team
National Institute for Infectious Diseases Lazzaro Spallanzani-Rome-Italy
[email protected]
WHO Collaborating Center for clinical care, diagnosis, response and training on
Highly Infectious Diseases
Ethical issues
• the INMI’s Institutional Ethical Board (IEB)
assessed the criteria for access to
experimental drugs and invasive procedures,
approved informed consent form.
• the patient signed an informed consent for
any single procedure or treatment performed
• the Italian Drug Agency (AIFA) issued
Emergency Use Authorization for
investigational new drugs
Key point of the management
• virological monitoring on a large set of different
biological specimen (urine, blood, stools, respiratory
secretion) which made it possible to document the
Ebola kinetics in different body compartments;
• the use experimental therapy;
• daily determination of EBOV RNA concentration in
blood to describe potential temporal association
between drugs administration and change in viremia
levels;
• close monitoring of blood counts and clinicalchemistry.
First Patient: Ebola RNA in lung
secretions
• documentation of interstitial pneumonia by Xrays with detection of Ebola RNA from unconcentrated lung secretion more than 100
times higher than in concomitant plasma
sample;
First patient: treatments
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Favipiravir
Convalescent plasma
ZMAb
Melanocortin
Second patient
• documentation of interstitial pneumonia by Xrays with detection of Ebola RNA from sputum
First patient: treatments
• Favipiravir
• Mill 77
Members of the INMI’s VHFs Team
• Crisis unit
21
Members of the INMI’s EBOV Team=61
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Infectious Diseases Physicians
Intensive Care Physicians
Nurses
Radiologists
Hospital pharmacist
Virologists and microbiologists
Electronic Microscopists
Drivers biocontainment ambulance
Engineers
Press Office
Logistician
11
5
14
1
1
23
2
2
2
5
1
Pathway towards the establishment of
High Isolation Facility
INMI as a model of response to emerging
IDs
Infrastructure of Pan-European Interest
2015
identified by EC in the ESFRI on Highly
Pathogenic Agents.
2011
WHO Collaborating Center for clinical care,
diagnosis, response and training on Highly 2009
Infectious Diseases
Coordination of EU Networks on BSL4, 2006
HIDs units, training in EIDs
emergencies, harmonization
2005 Ntl Referral Center for Avian Flu
Key words:
•Research
•Diagnosis
•Prevention
•Care
Ntl Referral Center for Bioterrorism
Approval of an High Isolation Facility,
new BSL4, 3 BSL3 labs and a
biocontainment cryobank
2000
Concept proposed for 1 BSL4
and 2 BSL3 lab
1995
1977
1996
2003
2001
-BSL4-authorized
-2 BSL3 and cryobank open
-Ntl Referral Center for SARS
-GOARN partner
BSL4 and 2 BSL3 labs open
Agreement with NIH-NIAID
New Clinical Center (200 beds at negative pressure) and a BSL3 Lab
Ntl Referral Center for VHFs
Isolation Unit for dangerous
pathogens with Biocontainement Lab
1975 National Referral Center for
Smallpox and dangerous IDs
1936 Opening IDs Center
Acknowledgments
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Italian Institutions
Ministry of health of Italy
Italian Air Force
National Blood Center
National Drug Agency- AIFA
Customhouses Fiumicino and Malpensa
The state police, the fire department and
Carabinieri national military police
• The Italian Red Cross
• The Lazio Region
Acknowledgments
• International Institutions
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World Health Organization WHO-Geneva
European Commission, DG
Special Pathogens Program, Public Health Agency of Canada
Infectious Diseases Royal Free London NHS Foundation Trust, London, United Kingdom
Centers for Disease Control and Prevention, Atlanta, GA, USA
Bernhard Nocht Institute for tropical medicine, Section Parasitology
University Hospital Frankfurt, Frankfurt/Main, Germany.
University Hospitals of Geneva, Switzerland, Intensive Care
Hospital La Paz, Madrid, Spain
Instituto de Salud Carlos III, Madrid, Spain (María Paz Sanchez-Seco, Pedro Anda)
Agence Nationale de Sécurité du Médicament et des produits de santé-ANSM
EPRUS (French Establishment for the Preparation and Response to Health Emergencies),
IHU Mediterranee Infection,Southern France
Service de Maladies Infectieuses et tropicales,
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Madrid-Spain (César
Hernàndez Garcìa)
Ministerio de Sanidad, Servicios Sociales e Igualdad, Madrid-Spain
Acknowledgments
• Industrial research, diagnostic,
pharmaceutical and regulatory companies
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Altona Diagnostics GmbH. Hamburg, Germany
Chimerix Ltd. Durham North Carolina- USA
Optum- Regulatory Services, Life Sciences Orlando, Florida
Toyama Chemical Co., Ltd./Fuji Chemical Industry Co., Ltd.
Japan
Medivector Boston, MA, USA
Mapp Biopharmaceutical, Inc. San Diego, CA USA
Health Ricerca e Sviluppo - HR&S, Massa Lombarda, RA, Italy
MChE-F4Pharma, Vienna, Austria
Accella Advisors GmbH, Uetliburg SG, Switzerland
The INMI’s motto is:
‘deeds not words’.