Cytomegalovirus infection in allogeneic stem cell transplant recipients
Conditions
Brief summary
csCMV infection is considered in case the patient requires pharmacological treatment according to standard clinical practice.
Detailed description
csCMV infection is considered in case the patient requires pharmacological treatment according to standard clinical practice., Clinical characteristic, Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by week 4 and week 14, Death by any cause and death not related with disease relapse or progression, Death by any cause non related to relapse by week 14 and day 180, Time to onset of all-cause failure of prophylaxis against CMV infection during the 14 weeks of study-drug administration period including patients who discontinued the study drug because of virologic failure or for any other reason (e.g., an adverse event, nonadherence, or consent withdrawal)., Duration of any CMV-antiviral treatment by day 180 post-SCT, Direct cost of CMV-antiviral treatment and hospital resource, Incidence of blips, clinical and analytic characteristics., Incidence of untreated CMV DNAemia, Adverse events according to the CTCAE, physical examination and regular laboratory tests. Only adverse events (AE) related to the treatment according to investigator, Incidence of aGVHD within 120 days after HCT and its onset and severity, Incidence of relapse within 180 days after HCT and its onset and severity, Incidence of CMV DNAemia requiring PET within 100-180 days after HCT, Incidence of non-CMV infections within 180 days after HCT and its onset and severity
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| csCMV infection is considered in case the patient requires pharmacological treatment according to standard clinical practice. | — |
Secondary
| Measure | Time frame |
|---|---|
| csCMV infection is considered in case the patient requires pharmacological treatment according to standard clinical practice., Clinical characteristic, Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by week 4 and week 14, Death by any cause and death not related with disease relapse or progression, Death by any cause non related to relapse by week 14 and day 180, Time to onset of all-cause failure of prophylaxis against CMV infection during the 14 weeks of study-drug administration period including patients who discontinued the study drug because of virologic failure or for any other reason (e.g., an adverse event, nonadherence, or consent withdrawal)., Duration of any CMV-antiviral treatment by day 180 post-SCT, Direct cost of CMV-antiviral treatment and hospital resource, Incidence of blips, clinical and analytic characteristics., Incidence of untreated CMV DNAemia, Adverse events according to the CTCAE, physical examination and regular laboratory tests. Only adver | — |
Countries
Spain