Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001903
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Prevention of RSV Infections in Bone Marrow Transplant Recipients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prevention of RSV Infections in Bone Marrow Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2000-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Respiratory Syncytial Virus RSV infections are very common and widespread By age 5 virtually everyone has been infected and developed antibodies against some strain of the virus RSV infections happen during adulthood leading to common cold syndromes In Bone Marrow Transplant recipients the disease is much more severe usually progressing to pneumonia This phenomenon is associated with mortality rates around 60-80
RSV Polyclonal Immunoglobulin Respigam Registered Trademark has been approved by the Food and Drug Administration and recommended by the American Academy of Pediatrics for prophylaxis of RSV disease in premature babies and children born with bronchopulmonary dysplasia Furthermore it has been used to treat RSV pneumonia in children and Bone Marrow Transplant recipients with encouraging results and no complications
Currently no preventive strategies are available when approaching this infection among bone marrow transplant patients We intend to prevent our bone marrow transplant patients from developing RSV pneumonia by employing the strategy already used in premature babies ie by passive immunization with Respigam Registered Trademark Our goal to evaluate the efficacy and safety of this strategy in such immunocompromised population
We believe that this will be a more reasonable approach than waiting for the infection to settle in and only then treating it because optimal therapy is not currently available
RSV Polyclonal Immunoglobulin Respigam Registered Trademark has been approved by the Food and Drug Administration and recommended by the American Academy of Pediatrics for prophylaxis of RSV disease in premature babies and children born with bronchopulmonary dysplasia Furthermore it has been used to treat RSV pneumonia in children and Bone Marrow Transplant recipients with encouraging results and no complications
Currently no preventive strategies are available when approaching this infection among bone marrow transplant patients We intend to prevent our bone marrow transplant patients from developing RSV pneumonia by employing the strategy already used in premature babies ie by passive immunization with Respigam Registered Trademark Our goal to evaluate the efficacy and safety of this strategy in such immunocompromised population
We believe that this will be a more reasonable approach than waiting for the infection to settle in and only then treating it because optimal therapy is not currently available
Detailed Description:
Respiratory Syncytial Virus RSV infections are very common and widespread By age 5 virtually everyone has been infected and developed antibodies against some strain of the virus RSV infections happen during adulthood leading to common cold syndromes In Bone Marrow Transplant recipients the disease is much more severe usually progressing to pneumonia This phenomenon is associated with mortality rates around 60-80
RSV Polyclonal Immunoglobulin Respigam Registered Trademark has been approved by the Food and Drug Administration and recommended by the American Academy of Pediatrics for prophylaxis of RSV disease in premature babies and children born with bronchopulmonary dysplasia Furthermore it has been used to treat RSV pneumonia in children and Bone Marrow Transplant recipients with encouraging results and no complications
Currently no preventive strategies are available when approaching this infection among bone marrow transplant patients We intend to prevent our bone marrow transplant patients from developing RSV pneumonia by employing the strategy already used in premature babies ie by passive immunization with Respigam Registered Trademark Our goal to evaluate the efficacy and safety of this strategy in such immunocompromised population
We believe that this will be a more reasonable approach than waiting for the infection to settle in and only then treating it because optimal therapy is not currently available
RSV Polyclonal Immunoglobulin Respigam Registered Trademark has been approved by the Food and Drug Administration and recommended by the American Academy of Pediatrics for prophylaxis of RSV disease in premature babies and children born with bronchopulmonary dysplasia Furthermore it has been used to treat RSV pneumonia in children and Bone Marrow Transplant recipients with encouraging results and no complications
Currently no preventive strategies are available when approaching this infection among bone marrow transplant patients We intend to prevent our bone marrow transplant patients from developing RSV pneumonia by employing the strategy already used in premature babies ie by passive immunization with Respigam Registered Trademark Our goal to evaluate the efficacy and safety of this strategy in such immunocompromised population
We believe that this will be a more reasonable approach than waiting for the infection to settle in and only then treating it because optimal therapy is not currently available
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-I-0083 | None | None | None |