• Information of staff involved in the medical care/nursing of trial subjects (e.g. physicians, nurses, cleaning staff, physiotherapist), |
• Proposal of serological testing of medical staff for H-1PV prior to the beginning and at the end of the trial (in order to document potential seroconversion), |
• Consideration of a subject as potentially viremic until: |
â—‹ A seroconversion as proven by HIT or ELISA, â—‹ In the absence of a seroconversion until proven lack of virus shedding in urine, saliva, and feces, |
• While a subject is considered as potentially viremic: |
○ Isolate her/him in a single room with its own toilet, ○ Use disposable gloves, protection gown and mask for handling of study medication and materials contaminated with ParvOryx, e.g. infusion materials, ○ Information of medical staff to use gloves, protection gown and mask when in physical contact with the patient, ○ Information of medical staff and visitors to use mask only when strictly omitting body contact with the subject during his/her isolation phase. Alternatively, the subject can wear a mask when in the same room with medical staff and visitors, ○ Information of hygiene staff to carry out a terminal disinfection after discharge of a subject from isolation, ○ In case of surface contamination the disinfection must be performed with Perform®, 3% |