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NCT00001903

Prevention of RSV Infections in Bone Marrow Transplant Recipients

Completed Phase 4 Last updated 3 March 2008
What this trial tests

Phase 4 trial testing RSV Polyclonal Immunoglobulin in Respiratory Syncytial Virus Infection in 120 participants. Completed in 1 May 2001.

Timeline
1 April 1999
1 May 2001

Quick facts

Lead sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Primary purposetreatment
Enrollment120
Start date1 April 1999
Estimated completion1 May 2001
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Eligibility, any sex, with Respiratory Syncytial Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Respiratory Syncytial Virus Infection

Currently open trials in the same condition.

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

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Data sources for this page

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