Prevention of RSV Infections in Bone Marrow Transplant Recipients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Dec 9, 2002

Keywords

ClinConnect 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 Pediatr...

Gender

ALL

Eligibility criteria

• • Male or female patients who are between the ages of 2 and 80 years.
• • Must be admitted to the Bone Marrow Transplant Unit for a bone marrow transplantation (BMT), peripheral stem cell transplantation (PSCT) or mini-transplantation (MT).
• • Must be in the early phase of BMT, PSCT or MT, i.e., receiving conditioning therapy for the transplant or within the first 30 days of receiving a bone marrow graft or;
• • Must be greater than 30 days post-engraftment but being treated for Graft vs. Host disease (GVHD) with a total dose of equal to or greater than 1.5 grams/m(2) of methylprednisolone (or equivalent dose of steroids) over the first 3 days.
• • Must have a negative result (at 48 hours) for RSV in the screening respiratory viral culture.
• • Less than 8 days have elapsed between meeting eligibility criteria, being contacted by one of the investigators, and making a decision to join the study.
• • Patients with signs or symptoms of Upper Respiratory Tract infection or pneumonia will be excluded until the etiology is established or RSV is ruled-out by the screening culture.
• • Patients will be excluded if they have any condition that, in the opinion of the investigator, could affect their safety, preclude evaluation of response, or render unlikely that the contemplated course of therapy can be completed.