NIH Study

[Dean1065]

Our last visit is at the 6 month mark. After that the follow up continues, but by phone.

[eljomom]

what is one to do for "prophylaxis" if a child has ivig and is PITAND? you can only "prophylax" with antibiotics things that abx will prevent, right? so I guess that is why they aren't trialing IVIG on PITAND kids. But truly, I am asking, what would one do?

 

 

Our son was one of the 1st to participate in the present NIH clinical trial. Sadly, they had not yet determined what would be an appropriate prophylactic antibiotic when we participated. DS got IVIG twice, got 90% better, then got strep three weeks after the 2nd IVIG. That was in July and we are still in the process of finding a course of action to undo that major set-back, eight months later. We are hoping to get IVIG in May and are still trying to work out the logistics so that we can get DS (now 13) functioning again.

 

Back in July, when we contacted NIH to tell them DS got strep in spite of his having religiously taken the antibiotics they prescribed, they said that we probably ought to go to a doctor and get some different antibiotics and then determine what prophylactic antibiotic we wanted to use moving forward. When we entered the study, I had naively assumed that NIH would be providing the advice and guidance on these types of issues. As we progressed, we found out that they were the experts until something did not go as intended and, from that point forward, we were pretty much on our own. Admittedly, I was bitter, at first. We went through so much to get DS well, and to watch it all come undone and have our world so quickly spiral back out of control again was devastating.

 

But, ultimately, I do believe that the folks at NIH care very much about helping to further the recognized research in this field. I also know that this does not necessarily put them in a position to help individual children - even, in some cases, the individual children who participate in their study. From what I understand, we were not the only family to have a child get strep right after treatment and lose the positive results that had arisen from participating.

 

Since it's a clinical trial, even though they knew full well that an additional IVIG treatment and different prophylactic antibiotics would rectify my son's situation, they were not in a position to offer those remedies.

 

Fortunately, for those clinical trial participants who have come after DS, NIH has now changed their recommended prophylactic antibiotic to something much more likely to prevent future strep infections. So, some good has already come out of my son's participation. It just wasn't necessarily beneficial to him, specifically.

 

As much as NIH does care, a clinical trial is a clinical trial. If necessary, one must be ready and willing to advocate for one's child even if this means seeking additional professional expertise beyond what NIH has to offer. All of this being said, I would highly recommend that anyone with a qualifying child seriously consider participating, both in terms of remedies and treatments for your child and in terms of advancing the state of research.

 

Was this when they were using once daily Amoxicillin as a prophylaxis? I could have told them that wasn't going to work.

 

So, after they 2nd IVIG, they didn't put your son on a better prophylaxis? Geesh.

 

Well, hopefully when they publish, they will make it crystal clear that aggressive steps (not once daily amoxicillin) to prevent Strep post-IVIG are needed, or a relapse WILL happen.

[eljomom]

bigmighty---did your child have a T&A??

 

Was this when they were using once daily Amoxicillin as a prophylaxis? I could have told them that wasn't going to work.

 

- We were told to give 500 mg azithro once a week, all at once, and instructed not to give more

 

So, after they 2nd IVIG, they didn't put your son on a better prophylaxis? Geesh.

 

- He was still on the very-low-dose azithro after 2nd IVIG and got strep. After that, when we contacted NIH to ask what we should do, they told us to get with a ped and figure out what antibiotics and what dose to try. Ped put DS on curative dose of Omnicef plus the Azithro. At one point during our e-mail exchanges, NIH recommended switching to low-dose Amox or a combo of Amox and Azithro. By then, we had already been to an ENT and an infectious disease specialist. They both recommended Keflex. So we stayed on Keflex until Dec, when Dr. Bouboulis switched us to Augmentin. I have heard from others who came later to the NIH trial that their children are on Augmentin prescribed by NIH. I am hoping that this does the trick for the present and future participants.

[eljomom]

my daughter got strep (asymptomatic except for increase in tics and night terrors) on that dose of zith.

 

 

We are currently on 5mg/kg. I'm sure we will discuss this more in depth on the return visit.

[EAMom]

what is one to do for "prophylaxis" if a child has ivig and is PITAND? you can only "prophylax" with antibiotics things that abx will prevent, right? so I guess that is why they aren't trialing IVIG on PITAND kids. But truly, I am asking, what would one do?

 

 

Our son was one of the 1st to participate in the present NIH clinical trial. Sadly, they had not yet determined what would be an appropriate prophylactic antibiotic when we participated. DS got IVIG twice, got 90% better, then got strep three weeks after the 2nd IVIG. That was in July and we are still in the process of finding a course of action to undo that major set-back, eight months later. We are hoping to get IVIG in May and are still trying to work out the logistics so that we can get DS (now 13) functioning again.

 

Back in July, when we contacted NIH to tell them DS got strep in spite of his having religiously taken the antibiotics they prescribed, they said that we probably ought to go to a doctor and get some different antibiotics and then determine what prophylactic antibiotic we wanted to use moving forward. When we entered the study, I had naively assumed that NIH would be providing the advice and guidance on these types of issues. As we progressed, we found out that they were the experts until something did not go as intended and, from that point forward, we were pretty much on our own. Admittedly, I was bitter, at first. We went through so much to get DS well, and to watch it all come undone and have our world so quickly spiral back out of control again was devastating.

 

But, ultimately, I do believe that the folks at NIH care very much about helping to further the recognized research in this field. I also know that this does not necessarily put them in a position to help individual children - even, in some cases, the individual children who participate in their study. From what I understand, we were not the only family to have a child get strep right after treatment and lose the positive results that had arisen from participating.

 

Since it's a clinical trial, even though they knew full well that an additional IVIG treatment and different prophylactic antibiotics would rectify my son's situation, they were not in a position to offer those remedies.

 

Fortunately, for those clinical trial participants who have come after DS, NIH has now changed their recommended prophylactic antibiotic to something much more likely to prevent future strep infections. So, some good has already come out of my son's participation. It just wasn't necessarily beneficial to him, specifically.

 

As much as NIH does care, a clinical trial is a clinical trial. If necessary, one must be ready and willing to advocate for one's child even if this means seeking additional professional expertise beyond what NIH has to offer. All of this being said, I would highly recommend that anyone with a qualifying child seriously consider participating, both in terms of remedies and treatments for your child and in terms of advancing the state of research.

 

Was this when they were using once daily Amoxicillin as a prophylaxis? I could have told them that wasn't going to work.

 

So, after they 2nd IVIG, they didn't put your son on a better prophylaxis? Geesh.

 

Well, hopefully when they publish, they will make it crystal clear that aggressive steps (not once daily amoxicillin) to prevent Strep post-IVIG are needed, or a relapse WILL happen.

 

In theory, the IVIG should help the PITAND kids.

 

But, yeah, no guarentees if they get hit by a nasty virus post-IVIG. That's why we've had to repeat IVIG (done 3 IVIG's so far) in a 2.5 year span...b/c of setbacks due to viral (fever) infections.

 

There are some anti-viral meds...not sure how many kids are on them.

Edited February 29, 2012 by EAMom

[bigmighty]

bigmighty---did your child have a T&A??

 

No. In fact, of the 11 medical professionals, plus NIH, that we have consulted so far, only one has suggested that we consider it. The others were opposed. DS still has his tonsils.

[Dean1065]

my daughter got strep (asymptomatic except for increase in tics and night terrors) on that dose of zith.

 

 

We are currently on 5mg/kg. I'm sure we will discuss this more in depth on the return visit.

 

I was wondering if you could tell me if the exacerbation was less severe while on the ABX dose or if you started over from scratch at that point?

 

Thanks-Dean

[bulldog24]

my son is 40 pounds and is on augmentin 400mg twice a day. /They might cut it back but i feel like leave well enough alone!

[EAMom]

my son is 40 pounds and is on augmentin 400mg twice a day. /They might cut it back but i feel like leave well enough alone!

 

agreed. Why mess with what is working and risk a relapse?