Transplant ID Clinical Research

The mission of the UPMC Transplant Infectious Diseases (TID) program is to support the transplant programs in heart, liver, lung, kidney, pancreatic and intestinal and multivisceral transplantation, as well as mechanical circulatory support, by preventing and treating infectious complications in solid organ transplant candidates and recipients.  The physicians in the group have expertise in a variety of transplant infectious disease-related topics, including but not limited to cytomegalovirus, fungal infections, respiratory viral infections, transplantation of patients infected with human immunodeficiency virus, infections with methicillin-resistant Staphylococcus aureus, infections due to Clostridium difficile, mycobacterial infections, and parasitic infections.

Research is integral to the TID mission. Members of the TID group are actively involved in clinical and translational research on a local and national level, and have published extensively on a variety of the above mentioned topics. Their research efforts span infectious conditions and microbes and share a focus on clinical applicability to patients. The clinical research team consists of a Program Director and experienced research staff that include nurses, laboratory specialists, non-health care workers, and grant administrators with expertise in clinical, data management, fiscal and regulatory aspects of all types of research trials.  Ongoing research efforts are funded by both internal and external sources including the National Institutes of Health, Clinical and Translational Scientific Collaboration, internal funding and pharmaceutical industry grants.

The TID group is involved in a variety of research studies addressing several topics including:

  • Novel therapy of cytomegalovirus infection
  • Effects of viral infections on transplanted organs
  • Safety & effectiveness of vaccination in transplant recipients
  • Epidemiology & treatment of influenza in transplant recipients
  • Respiratory viral infections, including rhinovirus in transplant recipients
  • Outcome studies of donor lung bronchial cultures in lung transplant recipients
  • Outcome studies of Staphylococcus aureus bacteremia in transplant recipients
  • Strongyloidiasis in transplant candidates & recipients
  • The use of home intravenous antibiotics in transplant recipients
  • Pre-transplantation screening to decrease the risk of post-transplant infections
  • The use of probiotics to limit recurrences of Clostridium difficile infections
  • Fecal Microbiome Transplants

Contact

Kailey Hughes Kramer
Falk Medical Bldg.
3601 Fifth Ave., Suite 5B
Pittsburgh, PA 15213
Telephone: 412-648-6453
E-mail: hugheskl4@upmc.edu

Transplant ID Clinical Trials

Title A Phase 3, Multicenter, Randomized, Open-label, Active-Controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients with Cytomegalovirus (CMV) Infections that are Refractory or Resistant to Treatment with Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir.
Description The study will assess the efficacy and safety of maribavir treatment in transplant recipients with cytomegalovirus (CMV) infections that are resistant or refractory to prior anti-CMV treatment.
Title Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients.
Description The study will evaluate the efficacy and safety of MK-8228 in Adult Kidney transplant recipients for prevention of cytomegalovirus (CMV)  disease in kidney transplant recipients
Title A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Optional Oral Fluconazole Step‑down in the Treatment of Subjects with Candidemia and/or Invasive Candidiasis.
Description The study is assessing the safety, tolerability and efficacy of Reafungin in the treatment of subjects with Candidemai and/or Invasive Candidiasis compared with standard of care treatments such as Caspofungin and fluconazole.
Title A Comparative Study to Evaluate Dual Amplification PCR Testing (MYCODART-PCR) of 6 Candida species in Patients with Documented Candidemia/Invasive Candidiasis. FUNGAL INFECTION NEW DIAGNOSTICS (FIND) STUDY.
Description The objective of this study is to compare the sensitivity and specificity of the MYCODART-PCR Candida Panel vs blood cultures in the detection of 6 different Candida species in blood specimens from patients with documented candidemia and/or invasive candidiasis.
Title A Phase 3, randomized, double-blind, active controlled study to compare the efficacy and safety of Ridinilazole (200 mg, bid) for 10 days with Vancomycin (125 mg, QID) for 10 Days in the Treatment of Clostridium difficile Infection (CDI).
Description The study will compare the safety and tolerability of 10 days dosing of ridinilazole with vancomycin in the treatment of patient with CDI.
Title Clinical Evaluation of the QuantiFERON CMV Assay
Description The study will validate the use of the QuantiFERON CMV Assay in the clinical setting for reassessing the risks of CMV infection in D+/R- Solid Organ Transplant (SOT) recipients after the completion of antiviral prophylaxis.
Title A multicenter, open-label, sponsor-blinded, randomized, active-controlled, parallel group, pivotal study to evaluate the efficacy, safety, and tolerability of murepavadin given with ertapenem versus an anti-pseudomonal-ß-lactam-based antibiotic in adult subjects with nosocomial pneumonia suspected or confirmed to be due to Pseudomonas aeruginosa.
Description The study is assessing the safety, tolerability and efficacy of murepavadin in adult subjects with nosocomial pneumonia suspected or confirmed to be due to Pseudomonas aeruginosa and compare length of intensive care unit (ICU) and hospital days with those subjects treated with standard of care (SOC) medications.
Title A Phase 2B, Open-label, Single-arm, First in Human Study of F901318 (orotomide)  as Treatment of Invasive Fungal Infections Due to Lomentospora prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options (FORMULA-OLS).
Description The study is assessing the safety, tolerability and efficacy of orotomide in the treatment of invasive fungal infections and other resistant fungi in patients who lack alternative treatments.
Title SERES-012: ECOSPOR III: A Phase 3 Multicenter, RandomizeEd, Double Blind, -Placebo COntrolled, -Parallel Group- Study to Evaluate the Safety, Tolerability, and Efficacy of SER-109 vs. Placebo to Reduce Recurrence of ClOstRidium difficile Infection (CDI) in Adults Who Have Received Antibacterial Drug Treatment for Recurrent CDI.
Description The study is assessing the safety, tolerability and efficacy of SER-109 vs placebo to reduce recurrence of C. difficile Infection (CDI) in adults who have received antibacterial drug treatment.
Title ECOSPOR IV: An Open-Label Phase 3 Extension of Study Series-012 Evaluating SER-109 in Adult Subjects with Recurrent Clostridium difficle Infection (RCDI)
Description The study will validate the use of the QuantiFERON CMV Assay in the clinical setting for reassessing the risks of CMV infection in D+/R- Solid Organ Transplant (SOT) recipients after the completion of antiviral prophylaxis.
Division of Infectious Diseases
Academic Administrative Office

818 Scaife Hall
3550 Terrace Street
Pittsburgh, PA 15261
Academic Office: 412-383-9062

For Patients: 412-647-7228

Center for Care of Infectious Diseases

Falk Medical Building
3601 Fifth Avenue, 7th Floor
Pittsburgh, PA 15213

Patient Appointments: 412-647-7228

Main CCID Fax: 412-647-7951