Fluid Expansion as Supportive Therapy (FEAST) trial. Kath Maitland on behalf of the FEAST team
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1 Fluid Expansion as Supportive Therapy (FEAST) trial Kath Maitland on behalf of the FEAST team
2 1998
3 Severe malaria: central role of acidosis More common than previously recognised ~70% cases Presents as respiratory distress Cerebral malaria 8-12% 20-40% Acidosis 15% Best independent predictor of a fatal outcome Many feature in common with sepsis Severe Anaemia ~1% Clinical studies: evidence for hypovolaemia Marsh et al, NEJM 1995
4 Research/Trials Phase I/II trials Severe malaria Severe anaemia Transfusion Sepsis Severe malnutrition Tribulations Constant funding crisis Grant rejections Hypothesis not supported Not a health priority Ethics of a clinical trial: Control unethical Albumin unethical Without PICU unethical
5 Soroti Hospital, Uganda 8000 admissions per year
6 2007 FEAST WAS FUNDED!!!
7 1/ Sick Child: Mother brings to hospital Fluid Expansion As a Supportive Therapy 2/ Triage : Child is a priority - nurse identifies asks doctor to see the quickly 3/ Doctor assesses & starts emergency treatments 4/ Assent /consent: trial nurse tells parent about FEAST trial 5/ FEAST trial: Treatments given Fast Slow 6/ Nurses observations and blood tests 7/ Recovery 8/ Going home 9/Follow up at one month
8 Setting up FEAST Fluid Expansion As a Supportive Therapy Sisyphus
9
10 Novel aspects: Operating within GCP guidelines Tailored pediatric life-support training course Dedicated GCP course for FEAST Emergency consent (first large trial to use this in Africa) All trial management run from Kilifi Open source software: for data management Fulltime FEAST monitors-initial GCP training and monitoring SAE - monitored real time & endpoint reviews-quarterly summaries to IRB.
11 Soroti & Mbale: Face-lift Paediatric wards & preparation of equipment required for FEAST
12 Mbale: Triage & Emergency Care
13
14 Signing of MOU in Mbale- hospital gave us a certificate of appreciation
15 Training, Consent and Monitoring
16 Training in Acute Paediatric Care: pre- and peri- trial on-site training Capillary refilling
17
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19 1996 Final rule exclusion from informed consent (EFIC) requirements subject has an immediately life-threatening condition; available treatments are unproven or unsatisfactory; Consent not feasible due to the urgency of the patient s condition; the research could not otherwise be performed; the risks and benefits are reasonable; prospect that the trial will be of direct benefit to the patient Consultation with the community from which subjects will be drawn
20 Communication: Leaflet for sites/communities
21 Interview of parent... I felt bad because you find that you have come all the way from home because your child is not feeling well, you have brought the child and instead of them taking an urgent step of treating the child they start asking for your opinions/advice (Mother, 24, no edn)
22 Soroti: Sister Mary Arumet knows the community very well! Parents respect & trust her!
23 Trial Monitoring from Kilifi Clinical trial facility FEAST monitors: Friendly policemen
24 Trial monitors : Closely working with the site coordinator
25 Post monitoring: Debriefing meeting
26 Recruitment Randomisation Cumulative Accrual - 15-NOV ,000 3,500 3,000 2,500 2,000 1,500 1, Target Cumulative Actual Cumulative
27 Timeline: last patient to release of results Dec Jan Feb Mar Apr May June 15th 12 th 13th 16th 5th 15th 7th 26th 30th Data lock 5 th interim analysis DMC met PI (KM) informed Last child enrolled TSC stops trial Last 28-day follow up Noosa ANZICS Meeting Final database lock Submit FEAST to NEJM Online Publication Paper published 4 months
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29 Dissemination Paediatric societies /academic institutions east Africa - paper, verbal presentations and DVD of FEAST video Press release FAQ s, youtube FEAST trial film Key policy makers WHO, policy makers Hospital management boards and community members by study PI s FEAST website Having a NEJM paper (open access)...
30
31 Close out...
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