Prevention of RSV Infections in Bone Marrow Transplant Recipients
RSV Polyclonal Immunoglobulin
Infections+4
+ RNA Virus Infections
+ Virus Diseases
Treatment Study
Summary
Study start date: April 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, United StatesOpen National Institute of Allergy and Infectious Diseases (NIAID) in Google Maps