Victor has been entered into a drug study, which I believe is called 'A Phase 3 Multi-Centre Randomised Placebo-Controlled Study of Azithromycin in the Primary Prevention of Radiologically-Defined Bronchiectasis in Infants with Cystic Fibrosis'. Catchy!
What this basically means is that there is an antibiotic (called Azithromycin) which has been shown to have anti-inflammatory properties as well as being an antibiotic. Apparently a lot of the damage to the lungs occurs from inflammation, not just infection, so the point is that hopefully this antibiotic can actually prevent that inflammation from occurring in the first place. I believe this has been long used for older CF patients, but the researchers want to find out if it is helpful for babies to start taking as a preventative (all signs point to yes).
It is a double-blind study, which means that we don't know if Victor is receiving the actual medicine or a placebo, and the researchers don't know either.
He gets 1.5mls of the antibiotic/placebo three times a week: Monday, Wednesday and Friday. Every time I give it to him I have to write in the study diary that he received it, or the reason why he didn't. I also have to keep all used bottles of antibiotic/placebo and return them to the researchers for accountability.
I have also been given a nasal swab kit in an insulated bag. If Victor catches a cold or has any other 'health event' then I have to take a swab from his nose and store it in the freezer. I can then transport it to the hospital in the insulated bag at the time of the next checkup/meeting with researchers. If he does have any kind of 'health event', such as a cold or a fever, I have to write that down, along with any other medicines he received aside from his usual ones. Vaccinations count as additional medicines, so I have to write down when he gets those too.
It sounds like a lot of extra work, as he will have this on top of his usual medications and treatments, and when we first started I was a little overwhelmed because it seemed confusing. Then I actually read through the information and realised that it's not really, just an extra medicine three times a week. I already tick off when he receives his other medicines so it's not anything extra.
Because he is in the study, he will have some checkups with the researchers in addition to his usual checkups with his CF team. The researchers also took data from his last procedure, the CT scan and bronchoscopy, even though that was part of his regular treatment.
Ideally, he will be in this study for three years. I really hope he is actually getting the antibiotic and not just the placebo, although we will have no way of knowing which he is getting and there's no one I can ask anyway. Possible side effects of the antibiotic would be getting an upset stomach and diarrhea, which is a common side effect of pretty much every antibiotic. If he did get these side effects we would stop taking part in the study. It's one of the gentler antibiotics apparently, quite safe and used for a very long time so the effects are very well known. The benefit of taking the antibiotic over the placebo is that he would be getting medication that would theoretically prevent lung damage from inflammation and stay healthier longer. And just because he is in the study he gets additional check ups so that can only be a good thing really!