1. Epidemiological, surveillance, clinical and pathogenesis studies: procedures standardization, inter-epidemic and baseline research development
WP LEADER: Giuseppe Ippolito, INMI Spallanzani
WP CO-LEADERS: Ibrahim Abubakar, Tim Mchugh, TBD
Start Month: 1 month
End Month: 48 month
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom

2. To improve patient management (IPC, diagnostics algorithms, etc) and clinical research at the clinical sites for EID.
To support National Stakeholders in the development of standardized management protocols and guide interventions should a large epidemic springs.
To provide a platform for the prompt implementation of  scientifically sound and rigorous studies (including controlled trials) during epidemics. To provide to Health Authorities a map of risk integrating human, animal and environmental data though integration with vet WPs
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom

3. WP Tasks No Task Task leader Participant 3.1
Development of clinical management protocols, including syndromic approach and IPC protocol easily adapted to different outbreaks
INMI
All clinical sites: IRRUA
CERMEL, IED, NIMR, IHI, University of Zambia
3.2
Development of a an adaptive trial platform and pre-approval by local authorities institutions
UCL
3.3
Burden of Hospital Acquired Infections and related antimicrobial resistance
Emergency
3.4
Etiology of acute febrile illnesses
NIMR
3.5
Sero-prevalence studies
IHI
3.6
Support to the development of an operational model for out break response teams
Chatam
3.7
Training and other support package for ORTs
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom

4. Task 3.1
Task: Development of clinical management protocols, including syndromic approach
and IPC protocol easily adapted to different outbreaks
Deliverables
Lead Participant
Timing
Evidence based standardized and validated protocols for clinical management of patients potentially
INMI
Month 40
Evaluation of syndromic protocols for five major clinical syndromes (i.e.: respiratory, neurologic
Month 24
Evidence based standardized and validated protocols for infection control procedures
UCL
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom

5. Task 3.1
Activity
Description
Preparatory phase
First technical meeting
In September To coordinate, establish needs and conduct for sites involved. Set up the major syndromes
Set up of a working group
To produce an inventory of the actual guidelines and protocol in place The different aspects of the protocol will be assigned to different working groups which will communicate through mails and
through two general meetings were the protocol will be discussed and agreed upon.
Development of protocols
Meeting with the working groups
Each working group will be assigned a specific aspect of the protocol which will communicate through mails and through two general meetings were the protocol will be discussed and agreed upon
Series of training
In collaboration with WP2 a series of training will be developed and conducted. Where possible we will promote collaboration with other networks when planning for the specific
courses.
Validation phase
Quasi experimental studies
Data on the feasibility and reliability of protocols will be collected through a quarterly assessment of selected
qualitative and quantitative feasibility indicators (lack of selected resources, community acceptance, appropriate capacity building of the staff)
PROGRESSES
Needs assessments and evaluations have been conducted in the following Institutions in order to adapt protocols to the situational analysis:
FCRM in June 2018 following the DRC Ebola outbreak. Evaluation and assessment form were procuced and a UCL mission concucted the assessment
Visit at Mercy Hospital Research Laboratory in Sierra Leone conducted by INMI and Rashid Ansumama in August 2018
Assessment and visit to NIMR, IHI ans SACIDS in July 2018 Tanzania conducted by INMI
Assessment and visit conducted by INMI at IED in Sudan in November 2018
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom

6. Task 3.2
Task: Development of a an adaptive trial platform and pre-approval by local authorities institutions
Deliverables
Lead Participant
Timing
Framework protocol and platform for adaptive clinical trials
INMI/UCL
Month 40
Activity
Description
Development of the Open (perpetual) adaptive platform trial*
Development of the Master protocol
The platform trial will share single master protocol and infrastructure across experimental treatments. Hence, all treatment arms share a common statistical analysis plan with predefined futility and success criteria.
Selection of pilot clinical sites and master site (for platform management)
Selection of candidate teatments
Training of the clinical sites
*This strategy is an open adaptive platform clinical trial with a fixed number of active treatments and a control. The trial is ‘‘open’’ with respect to adding new treatments to replace ineffective treatments during the trial.
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom

7. Task 3.3
Task: Burden of Hospital Acquired Infections and related antimicrobial resistance
Deliverables
Lead Participant
Timing
Report on the burden of AMR and HAI in the clinical sites
Eberhard Karls Universitaet Tuebingen
Month 24
Pilot AMR incidence study in Sudan
EMERGENCY
Month 36
Activity
Description
Report on the burden of AMR and HAI in the clinical sites
Survey on existing data from the PANDORA clinical sites
Disegn of a survey using the existing infrastrucrure and testing in collaboration with WP2
Pilot AMR incidence study in Sudan
Protocol design
A pilot study on the coomunity AMR will be conducted in the clinical sites of EMERGENCY in Kartoum (mainly MAYO Camp) and Port Sudan
Implementation of diagnostic testing
Study conduction and analysis
The study will be conducted for 24 months
Progresses
A mission has been conducted in Sudan in November 2018 at Emergency Center in order to assess needs and evaluate feasibility of the study protocol
For a pilot AMR study, a study protocol has been dveloped by ITM-EKUT and a implementation plan for diagnostic testing has been discussed. This has been posted in PANDORA online portal.
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom

8. Task 3.4
Task: Etiology of acute febrile illnesses
Deliverables
Lead Participant
Timing
Population studies to assess potential epidemic/pandemic threats
INMI
Month 40
Incidence and prevalence map
UCL
Activity
Description
Population studies to assess potential epidemic/pandemic threats
peer-reviewed and grey literature
on studies reporting incidence and prevalence of the infectious agents with epidemic potential in the different
regions included in the project
Development of the study protocol
Random sampling methods will be used and syndromic approach will be developed to select a panel of diagnostic tests to be performed. A prospective cohort study enrolling all consecutive patients evaluated with acute febrile illness at the clinical sites.
Selection of panel of tests
will be chosen and samples will be collected accordingly with the syndromic approach in collaboration with WP2
Ethical clearance
submitted to the different ethical committees in each country
Incidence and prevalence map
Integration with data from the animal WPs
Creation of a risk map
Progresses
A project workshop has been conducted in dar es salaam on 28th of July 2018 in order to discuss with the presence of the MoH the priorities for research, preparedness and response.
A protocol is in progress to address epidemiological, clinical management and social risk for establishing the burden of arbovirus disease in Tanzania
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom

9. Task 3.5
Task: Sero-prevalence studies
Deliverables
Lead Participant
Timing
Sero-prevalence study to describe circulation of selected infectious agents
Institut für Virologie - Charité
Month 40
Activity
Description
Sero-prevalence study to describe circulation of selected infectious agents
the sero-surveys of arbovirus infections
will be rigorously designed and conducted to consolidate knowledge on their magnitude in the region
peer-reviewed and grey literature
on studies reporting incidence and prevalence of the infectious agents with epidemic potential in the different
regions included in the project
Development of the study protocol
The randomization methods will be tailored on the transmission of pathogens, the social and geographic characteristics of the area (i.e. for vector-borne transmission, blood donation center could be used for adults, urban vs rural area, etc). For specific diseases, high risk
group will be targeted (i.e. for zoonotic diseases the subject clusters will be selected in collaboration with the zoonosis WPs in area with environmental suitability for the specific pathogens).
Selection of panel of tests
will be chosen and samples will be collected accordingly with the syndromic approach in collaboration with WP2
Ethical clearance
submitted to the different ethical committees in each country
Training of clinical sites
Progresses
A protocol is in progress to address epidemiological, clinical management and social risk for establishing the burden of arbovirus disease in Tanzania
A study protocol for evaluation of the seroprevalence of viral dieseases has been developed together with the PI in Gabon Selidji Agnandji, and had been handed to the Indepent ethics committee for Ethical approval of the study.
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom

10. Main challenges
Cross WP collaboration for the writing and implementation of protocols
Baseline data from the participating centers
List of priority diseases (based on research needs) – WP4-5
Setting of working group (Disease-specific? Field-specific?)
Collaborations with public health networks/organizations
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom

11. Next step (two months)
Cross WP collaboration for the writing and implementation of protocols
Baseline data from the participating centers
List of priority diseases (based on research needs) – WP4-5
Setting of working group (Disease-specific? Field-specific?)
Collaborations with public health networks/organizations
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom

12. Task
Task:
Support to the development of an operational model for out break response teams
Training and other support package for ORTs
Deliverables
Lead Participant
Timing
Assessment of current capacities and capabilities of key institutions
Mercy Hospital Research Laboratory
Month 6
Operational model for outbreak response teams
Chatam House
Month 24
Training and other support packages for the ORTs)
Month 36
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom

13. Thanks for your attention
PANDORA-ID-NET is part of the EDCTP2 Programme supported by the European Union under Grant agreement RIA2016E-1609
Co-funded by The National Institute for Health Research, United kingdom