Infection Clinical Trial
Official title:
A Randomized Phase III Study To Evaluate The Safety And Efficacy Or Ribavirin Inhaled Solution In Preventing Progression Of Upper Respiratory Tract Respiratory Syncytial Virus (RSV) Infection To RSV Pneumonia In Blood And Bone Marrow Transplant (BMT) Recipients
RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It
is not yet known if ribavirin is more effective than standard therapy in preventing
pneumonia in patients who have respiratory syncytial virus (RSV) infection following stem
cell transplantation.
PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with that of
standard therapy in preventing pneumonia in patients who have RSV infection following stem
cell transplantation.
OBJECTIVES:
- Compare the efficacy of aerosolized ribavirin vs standard supportive therapy, in terms
of preventing progression of upper respiratory tract respiratory syncytial virus (RSV)
infection to pneumonia, in patients with RSV following stem cell transplantation.
- Determine the safety of aerosolized ribavirin in this patient population.
OUTLINE: This is a randomized, investigator-blind, controlled, multicenter study. Patients
are stratified according to engraftment status (pre vs post) and transplant type (HLA
matched-related allogeneic, syngeneic, or autologous vs HLA mismatched-related or unrelated
allogeneic). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive standard supportive care for immunocompromised patients with
upper respiratory tract infections. Patient also receive aerosolized ribavirin by face
mask, mist, or oxygen tent over 2 hours 3 times daily on days 1-10.
- Arm II: Patients receive standard supportive care as in arm I. Treatment continues in
the absence of progression to pneumonia or unacceptable toxicity.
Patients are followed at days 14 and 28.
PROJECTED ACCRUAL: A total of 90 patients (45 per arm) will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04529421 -
Assocation Between In-person Instruction and COVID-19 Risk
|
||
| Recruiting |
NCT04081792 -
Optimal Antibiotics for Operated Diabetic Foot Infections
|
N/A | |
| Completed |
NCT04332861 -
Evaluation of Infection in Obstructing Urolithiasis
|
||
| Recruiting |
NCT04674657 -
Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
|
||
| Enrolling by invitation |
NCT05052203 -
Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
|
||
| Recruiting |
NCT00342589 -
New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
|
||
| Completed |
NCT03295825 -
Heparin Binding Protein in Early Sepsis Diagnosis
|
N/A | |
| Completed |
NCT03296423 -
Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly
|
Phase 4 | |
| Withdrawn |
NCT04217252 -
Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection
|
N/A | |
| Recruiting |
NCT02905552 -
Myelodysplasic Syndromes and Risk Factors for Infection
|
N/A | |
| Recruiting |
NCT02899143 -
Short-course Antimicrobial Therapy in Sepsis
|
Phase 2 | |
| Withdrawn |
NCT02904434 -
Gastrointestinal Implications of Voriconazole Exposure
|
||
| Active, not recruiting |
NCT02768454 -
Antimicrobials Stewardship by Pharmacist
|
N/A | |
| Completed |
NCT02219776 -
Decreasing Infection In Arthroscopic Shoulder Surgery
|
N/A | |
| Completed |
NCT02210169 -
RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
|
N/A | |
| Recruiting |
NCT02098226 -
Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts
|
N/A | |
| Completed |
NCT01846832 -
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
|
Phase 3 | |
| Completed |
NCT01434797 -
Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
|
||
| Terminated |
NCT01441206 -
Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants
|
Phase 1 | |
| Completed |
NCT01159834 -
Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)
|
N/A |