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Prevention of RSV Infections in Bone Marrow Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001903
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition Intervention Phase
Respiratory Syncytial Virus Infection Drug: RSV Polyclonal Immunoglobulin Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Prevention of RSV Infections in Bone Marrow Transplant Recipients

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 120
Study Start Date: April 1999
Estimated Study Completion Date: May 2001
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, 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001903


Locations
United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001903     History of Changes
Other Study ID Numbers: 990083
99-I-0083
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: March 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
Immunization
Immunocompromised
Immunoglobulin
Prophylaxis
Respiratory Virus
Bone Marrow Transplantation
Mini-Transplantation
Peripheral Stem Cell Transplantation

Additional relevant MeSH terms:
Infection
Communicable Diseases
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs