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Clinical Studies
RSV Prophylaxis Study
A Study of the Safety, Tolerance and Efficacy of Palivizumab (SynagisÒ
) for Prophylaxis of Respiratory Syncytial Virus in Children with
Congenital Heart Disease
Penn State Hershey Medical Center is part of a multi-center study of
the safety, tolerance and efficacy of Palivizumab (Synagis ). Synagis is
a "humanized" monoclonal antibody manufactured by recombinant
DNA technology. Synagis is a new medication that is used to prevent
respiratory syncytial virus (RSV) infections. The study period will be
from October 2000 until approximately May 2001.
Synagis has been studied in children with prematurity and
bronchopulmonary dysplasia (BPD) and has been shown to be safe and
effective to decrease the incidence of RSV infection and
hospitalizations. Based on this study, Synagis was approved by the FDA.
However, children with congenital heart disease (CHD) were not evaluated
in the study. The past two years Hershey Medical Center has been
actively involved with this study. The study will continue this winter
and likely one more year thereafter.
Past experience with other medicines used to prevent RSV
infections:
Respigam is a polyclonal antibody preparation that was studied in 416
children with CHD. This study demonstrated increased cyanotic episodes
in cyanotic infants (shunt malfunction, increased cyanosis and death).
Proposed mechanisms for these increased adverse events with Respigam
include: (1) the large volume and dose (750mg intravenously) required
and (2) the protein load of the polyclonal antibody product. In
addition, Respigam interfered with timing of routine immunizations.
During this study, the following is required:
| 1. |
Five monthly intramuscular (IM) injections and one
visit one month after the final |
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injection (six visits total). |
| 2. |
Blood sample for SynagisÒ blood levels at the first,
second and fifth visits. |
| 3. |
If surgery is performed during the study period, blood
levels of SynagisÒ will be |
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obtained before and after surgery. |
| 4. |
If there are any signs or symptoms of upper
respiratory infection or RSV infection, |
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an RSV nasal washing test will be obtained. |
| 5. |
Close follow up with the study coordinator and
principle investigator regarding any |
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"adverse events." |
The study is randomized, placebo controlled and double blinded. This
means that there is a 50-50 chance (like flipping a coin) of receiving
Synagis or an inactive substance (placebo). The parents, doctors, nurses
and pharmacists involved in the study will not know which child is
receiving Synagis or the placebo. This is necessary to fairly study the
drug and remove all possible bias in reporting the results.
ELIGIBILITY:
| 1. |
24 months of age or younger. |
| 2. |
Documented hemodynamically significant cyanotic and
acyanotic CHD (simple, small ASDs, VSDs and PDAs are not eligible). |
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Example: VSD requiring medical therapy for CHF is
eligible. |
| 3. |
Unoperated or partially corrected CHD. Example:
Hypoplastic left heart after 1st or 2nd staged
operation. |
EXCLUSION:
| 1. |
Unstable or severe disease that survival is unexpected
or heart transplant is planned. |
| 2. |
Hospitalization (unless discharge is expected within
21 days). |
| 3. |
Cardiac surgery planned within two weeks. |
| 4. |
Mechanical ventilation or other support. |
| 5. |
Associated non-cardiac anomalies or end-organ
dysfunction such that survival is < 6 months. |
| 6. |
Known HIV positive. |
| 7. |
Presence of acute RSV or other acute infection or
illness. (Must have NEG RSV test if symptomatic). |
| 8. |
Previous administration of SynagisÒ or other
monoclonal antibody. |
| 9. |
Use of other investigational agents within the last 3
months. |
| 10. |
Current participation in other investigational
protocols. |
| 11. |
IVIG use within 3 months, or anticipated use of IVIG
or SynagisÒ during the study period. |
Please direct questions regarding this study to:
Kerry L. Rosen, MD Principle Investigator 717-531-6847 krosen@psu.edu
Sarah A. Sturgis, RN, CRNP Study Coordinator 717-531-7762 ssturgis@psu.edu
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