Prevention of RSV Infections in Bone Marrow Transplant Recipients
Status:
Completed
Trial end date:
2001-05-01
Target enrollment:
Participant gender:
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, i.e., 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.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)