American Society of Transplantation Recommendations for Screening, Monitoring and Reporting of Infectious Complications in Immunosuppression Trials in Recipients of Organ Transplantation

Abstract

In recent years, major progress has been made in the development, investigation and clinical application of novel immunosuppressive drug therapies to prevent acute rejection. Critical to the ultimate clinical application of new drug therapies is the ongoing performance of large multi-center clinical trials. However, there has been a paucity of infectious disease monitoring built into these protocols. Given that infectious complications are a major source of morbidity and mortality in transplant recipients, the assessment of the magnitude of risk of infection associated with a given immunosuppressive strategy may be as important as the assessment of rejection. For the above reasons, screening, monitoring and reporting recommendations for common transplant-associated infections were developed for use in clinical trials evaluating immunosuppressive strategies. These recommendations have two major goals: (i) to provide clinically relevant definitions for tracking infectious complications occurring in participants in immunosuppressive trials and (ii) where appropriate, to recommend specific laboratory monitoring and surveillance methods.

18F-FDG PET/CT for the Diagnosis of Malignant and Infectious Complications After Solid Organ Transplantation

“…Moreover, single-lung transplant confers a significantly elevated risk of developing primary lung cancer in native lung [37]. Infectious diseases are also life-threatening complications in an immunosuppressive context, and they can potentially affect several organs [38]. Therefore, a diagnostic tool able to detect the appearance of post-transplant complications during follow-up with high sensibility is mandatory to optimize the therapeutic strategy.…”

Impact of Antiviral Preventive Strategies on the Incidence and Outcomes of Cytomegalovirus Disease in Solid Organ Transplant Recipients

“…Patients without such a prophylactic treatment who were at risk for CMV disease (Dþ/RÀ and Rþ patients) were considered as being managed by the preemptive approach. Definition of CMV disease followed international guidelines (21). Active CMV infection was defined as the evidence of laboratory confirmation of CMV replication irrespectively of symptoms.…”

Investigation of BK and JC Virus DNA Positivities by Real-Time Polymerase Chain Reaction in Immunosuppressive Patients

“…Bu durumu ≥10 7 kopya/ml olan BK virüs miktarı ile ilişkilendirmişlerdir (8) . Amerikan Transplantasyon Derneği'nin de verilerine göre idrarda polyomavirus DNA'sının ≥10 7 kopya/ml, plazmada ≥10 4 kopya/ml düze-yinde bulunması durumunda nefropati gelişebil-mektedir (15) .…”