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NCT00001903
Prevention of RSV Infections in Bone Marrow Transplant Recipients
Phase 4 trial testing RSV Polyclonal Immunoglobulin in Respiratory Syncytial Virus Infection in 120 participants. Completed in 1 May 2001.
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 April 1999 |
| Estimated completion | 1 May 2001 |
| Sites | 1 location across United States |
Drugs / interventions tested
- RSV Polyclonal Immunoglobulin — full drug profile →
Conditions studied
- Respiratory Syncytial Virus Infection — all drugs for Respiratory Syncytial Virus Infection →
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.
Verify or expand the search:
- PubMed search for NCT00001903
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Related trials
Other recruiting trials for Respiratory Syncytial Virus Infection
Currently open trials in the same condition.
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- NCT06604767 — Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged · Phase 1 · active not recruiting
Other National Institute of Allergy and Infectious Diseases (NIAID) trials
Trials by the same sponsor.
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- NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00001903 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 3 March 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00001903.
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