A multicenter, longitudinal, interventional, double blind randomized clinical trial in hematopoietic cell transplant recipients residing in remote areas: Lessons learned from the late cytomegalovirus prevention trial
| Autor: | Genovefa A. Papanicolaou, Michael Boeckh, Roy F. Chemaly, Christi Dahlgren, Keith R. Jerome, W. Garrett Nichols, Margaret L. Green, Terry Stevens-Ayers, Hu Xie, Louise E. Kimball, Renee LeBlanc, Mary E.D. Flowers |
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| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Phases of clinical research Cytomegalovirus 030204 cardiovascular system & hematology Neutropenia Placebo Article law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine medicine 030212 general & internal medicine Anti-viral treatment Pharmacology lcsh:R5-920 business.industry Valganciclovir General Medicine medicine.disease 3. Good health Surgery Granulocyte colony-stimulating factor Transplantation Absolute neutrophil count Good clinical practice business lcsh:Medicine (General) medicine.drug |
| Zdroj: | Contemporary Clinical Trials Communications, Vol 4, Iss C, Pp 84-89 (2016) Contemporary Clinical Trials Communications |
| ISSN: | 2451-8654 |
| DOI: | 10.1016/j.conctc.2016.05.002 |
| Popis: | Purpose: The logistics of conducting double-blinded phase III clinical trials with participants residing in remote locations are complex. Here we describe the implementation of an interventional trial for the prevention of late cytomegalovirus (CMV) disease in hematopoietic cell transplantation (HCT) subjects in a long-term follow-up environment. Methods: A total of 184 subjects at risk for late CMV disease surviving 80 days following allogeneic HCT were randomized to receive six months of valganciclovir or placebo. Subjects were followed through day 270 post-transplant at their local physician's office within the United States. Anti-viral treatment interventions were based on CMV DNAemia as measured by polymerase chain reaction (PCR) (>1000 copies/mL) and granulocyte colony stimulating factor (G-CSF) was prescribed for neutropenia (absolute neutrophil count (ANC |
| Databáze: | OpenAIRE |
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