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- Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe, Kineret (anakinra) / SOBI, Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
The Unfortunate Trifecta: Tuberculosis, EBV, and CMV Induced Hemophagocytic Lymphohistiocytosis (Marriott Marquis San Diego Marina, Pacific Ballroom 15-17 (Ground Floor, North Tower)) - Feb 20, 2024 - Abstract #ATS2024ATS_8170;
Case report: A 52-year-old male with history of end-stage renal disease underwent deceased donor kidney transplant two years prior to presentation and was maintained on mycophenolate, tacrolimus, and prednisone...Broad infectious workup resulted in CMV and EBV viremia, treated with intravenous valganciclovir and cytogam...High clinical suspicion for HLH (H-score 218, 93-96% probability) prompted therapy with dexamethasone and anakinra (IL-1 blocker) following biopsy...Globally, cases of MTB induced HLH have a 54% survival rate, with diagnostic delay resulting in delay of appropriate antimicrobials and worse outcomes. These diagnostic delays warrant consideration of empiric MTB therapy for immunocompromised patients under suspicion for HLH.
- A Case of Idiopathic Pneumonia Syndrome in a Patient With Recent Stem Cell Transplant (San Diego Convention Center, Area H (Hall H, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_5651;
Early recognition and intervention are crucial for achieving favorable outcomes in these challenging cases. This also highlights the importance of treating possible infectious etiologies while awaiting workup and when unable to rule out certain infections.
- Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
Adjunctive Cytogam and CMV Insight T-Cell Immunity Assay for Refractory CMV Disease in Heart Transplant Recipients - Single-Center Case Series of Challenging Cases (Poster Hall) - Jan 9, 2024 - Abstract #ISHLT2024ISHLT_1466;
She was admitted to receive IV cidofovir and CytoGam 100mg/kg every week for 6 weeks and is thriving after completing long-term treatment with letermovir with CMV viral load at less than 137 [IU/mL]...CytoGam therapy was associated with decreased circulating viral loads and was well-tolerated. Further study of approaches including traditional antiviral agents, passive humoral immunotherapy (such as CytoGam) is needed.
- MULTIORGAN FAILURE DUE TO CMV-INDUCED HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (Convention Center Exhibit Hall) - Aug 4, 2023 - Abstract #CHEST2023CHEST_4198;
- || Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
The saddest thing about this story is active CMV is easy to diagnose and can be treated with CytoGAM. (Twitter) - May 25, 2022
- Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Incidence and Outcomes of CMV Infection in Pancreas Transplant with Thymoglobulin Induction: A Single Center Experience (Hynes Halls C & D: Board No. B281) - May 20, 2022 - Abstract #ATC2022ATC_2665;
CMV viremia in PTR did not affect patient or graft survival, however, higher rates of PTD were noted in the viremic group. In our experience, most patients can be successfully treated with decreased immunosuppression and PO valganciclovir or IV ganciclovir.
- || Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
Retrospective data, Review, Journal: Effectiveness of Prophylactic Human Cytomegalovirus Hyperimmunoglobulin in Preventing Cytomegalovirus Infection following Transplantation: A Systematic Review and Meta-Analysis. (Pubmed Central) - Mar 26, 2022
Similar results were observed in analyses limited to publications evaluating currently available CMVIG products (Cytotect CP and Cytogam; p < 0.001). In combination with the established safety profile for CMVIG, these results suggest that prophylactic CMVIG treatment in patients undergoing solid organ transplantation may be beneficial, particularly in those at high risk of CMV infection or disease.
- | Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
Trial completion: A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (clinicaltrials.gov) - Sep 22, 2021
P3, N=399, Completed, Sponsor: The George Washington University Biostatistics Center
In combination with the established safety profile for CMVIG, these results suggest that prophylactic CMVIG treatment in patients undergoing solid organ transplantation may be beneficial, particularly in those at high risk of CMV infection or disease. Active, not recruiting --> Completed
- | Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
Enrollment change: A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (clinicaltrials.gov) - Oct 19, 2020
P3, N=399, Active, not recruiting, Sponsor: The George Washington University Biostatistics Center
Active, not recruiting --> Completed N=800 --> 399
- | Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
Trial completion date: A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (clinicaltrials.gov) - Jan 30, 2019
P3, N=800, Active, not recruiting, Sponsor: The George Washington University Biostatistics Center
N=800 --> 399 Trial completion date: Dec 2018 --> Aug 2021
- | Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
Enrollment closed, Trial primary completion date: A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (clinicaltrials.gov) - Jun 14, 2018
P3, N=800, Active, not recruiting, Sponsor: The George Washington University Biostatistics Center
Trial completion date: Dec 2018 --> Aug 2021 Recruiting --> Active, not recruiting | Trial primary completion date: May 2018 --> Nov 2018
- | Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Zinbryta (daclizumab) / Biogen, AbbVie
Trial completion, Enrollment change, Trial initiation date: Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch (clinicaltrials.gov) - Dec 20, 2017
P3, N=56, Completed, Sponsor: Johns Hopkins University
Recruiting --> Active, not recruiting | Trial primary completion date: May 2018 --> Nov 2018 Recruiting --> Completed | N=110 --> 56 | Initiation date: Jan 2006 --> Jan 2007
- | Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
Trial completion: Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection (clinicaltrials.gov) - Feb 16, 2016
P4, N=40, Completed, Sponsor: Medical University of South Carolina
Recruiting --> Completed | N=110 --> 56 | Initiation date: Jan 2006 --> Jan 2007 Active, not recruiting --> Completed
- | Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
Trial completion: Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation (clinicaltrials.gov) - Jun 29, 2015
P4, N=26, Completed, Sponsor: Tampa General Hospital
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
Enrollment closed: Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection (clinicaltrials.gov) - Feb 27, 2014
P4, N=40, Active, not recruiting, Sponsor: Medical University of South Carolina
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
Trial initiation date: A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (clinicaltrials.gov) - Jun 21, 2012
P3, N=800, Recruiting, Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Recruiting --> Active, not recruiting Initiation date: Aug 2011 --> Apr 2012
- | Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
Enrollment open: A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (clinicaltrials.gov) - Jun 21, 2012
P3, N=800, Recruiting, Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Initiation date: Aug 2011 --> Apr 2012 Not yet recruiting --> Recruiting
- Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
Trial completion: The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease (clinicaltrials.gov) - Jun 21, 2012
P=N/A, N=28, Completed, Sponsor: University of Wisconsin, Madison
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
New P4 trial: Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection (clinicaltrials.gov) - Jan 11, 2012
P4, N=40, Active, not recruiting, Sponsor: Medical University of South Carolina