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2.3 KiB
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- Jose Muñoz y Almudena
- The main target is safety, then effectiveness of STH. Scabies is neglected even between NTDs.
- SAC, Kenya and Ghana
- Control arm: alb 400mg
- Experimental arm: alb 400mg / ivm 9mg or alb400mg/ivm18mg
- Informed consent, screening. randomization list. Ranzomization is between schools, right?
- Active surveillance from day 0 to day 2. On day 7 final visit to make sure we find out about most SAEs.
- Stool examination only for some. To test for hookworm, ascaris, t.trichiura.
- Month 11: strongyloides. we're doing serology for it.
- for the CRF: why are we not using directly tablets for it. We're using paper: it was a matter of cost on one site, the CFR is rather short. Maybe its good a idea to put it on paper and transfer it to the CRF.
- Stella: In terms of regulatory, if Redcap has trazability entonces sí podemos, pero si no no. Is it possible to sign or countersign. That is one of the things you keep hearing.
- EMA has very strict requirements about software for Clinical trials.
- We can have source documents that are electronic or not, mainly a matter for the teams at GHS and KEMRI.
- The priority is to get the work done and then. We might not do it daily and then the forms will be entered later.
- Detection of rare adverese events with a frequency with 1/3000.
- 75 participants from each school para hacer la parte dle estuio relacionada con eficacia.
- Now we're on the trial setup. How are we going to fulfill all the regulatory requierements. In every country it is different.
- Informed consent / informed assent - country specific version.
- Finding the schools, which are the ones that fulfill the RCT requierements?
- Hay beef sobre cuál es la coverage y cómo la medimos y si estamos de acuerdo en cuánto de importante es.
- Ojo que hay que enmendar el protocolo del RCT. Ghana is working for starting in october/november
- Kenia puede empezar como pronto en octubre, pero todavía itnene que hablar con el MoH para ver si pueden.
- In kenya some times politicians can use the deworming as a political tool. They buy the medicine and darlo. pero además WHO va a mandar medicinas esperadas en septiembre con el plan de darlas en noviembre.
- Se llega a la conclusión de que se van a tomar Direct Blood Samples y además se van a hacer rapid test en un 10% de las muestras (unas 450) en los dos países para intentar hacer de validadores