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Department of Medicine

Department of Medicine

   Division of Infectious Diseases

Research - Clinical Research


Transplant ID Ongoing Clinical Trials


Ongoing Clinical Trials


Title

TANGO II Project

Rempex-506 A Phase 3, Multi-Center, Randomized, Open-Label Study of Carbavance (Meropenem/RPX7009) Versus Best Available Therapy in Subjects with Selected Serious Infections due to Carbapenem-Resistant Enterobacteriaceae.

Description

Open label study of Carbavance (Meropenem/RPX7009) versus best available therapy in subjects with infections due to carbapenem resistant enterobacteriaceae (CRE).

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

Actelion C-diff Project

Protocol AC-061A301:  A multi-center, randomized, double-blind study to compare the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Description

To compare the efficacy and safety of cadazolid versus vancomycin in subjects with clostridium difficile associated diarrhea (CDAD).

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

STAMP Study

Serial Therapeutic and Antifungal Monitoring Protocol (STAMP).

Description

To determine the T2Candida performance as a monitoring tool for post-therapy clearance of Candida compared to blood culture.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

SCYNEXIS Protocol

CY-078-202:  A Prospective, Multicenter, Open-Label, Randomized, Comparative Study to Estimate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Oral SCY-078 vs. Standard-of-Care Following Initial Intravenous Micafungin Therapy in the Treatment of Invasive Candidiasis (Including Candidemia) in Hospitalized Nonneutropenic Adults.

Description

Comparative study to estimate the safety, tolerability, pharmacokinetics, and efficacy of oral SCY-078 vs. SOC following initial IV Micafungin therapy in the treatment of invasive candidiasis in hospitalized non-neutropenic adults.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

DAS181 Trial

DAS181-2-05: A Phase II, Randomized, Double-blind, Placebo-controlled study to examine the effects of DAS181 in immunocompromised subjects with Lower Respiratory Tract Parainfluenza Infection on Supplemental Oxygen.

Description

The study will examine the effects of DAS181 in immunocompromised subjects with lower respiratory tract para influenza infection on supplemental oxygen.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

GILEAD Project

GS-US-218-1797 : A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV) Infection.

Description

Randomized study evaluating GS-5806 in Lung Transplant recipients with Respiratory Syncytial Virus (RSV) Infection to determine best treatment.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

PIVOTAL Trial

T2Bacteria Panel Pivotal Study.

Description

This study is to demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole blood clinical samples.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

CREDIBLE Study

A Multicenter, Randomized, Open-label Clinical Study of S‑649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem‑resistant Gram-negative Pathogens.

Description

The study is to demonstrate the safety and effectiveness of the study drug, S‑649266 in treating severe infections caused by Carbapenem-resistant Gram negative pathogens.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

Shire Study

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 compare the efficacy of maribavir to investigator-assigned anti-CMV therapy in CMV viremia clearance after 8-week treatment in transplant recipients who are refractory or resistant to prior anti-CMV treatment.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

Mycos Project

A multi-Center Cohort Study of the Short and Long Term Safety of Micafungin and Other Parenteral Antifungal Agents.

Description

The project will establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal agents.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

HAVEN Study

Flu vaccine effectiveness in those hospitalized in a large diverse health system.

Description

The study will determine vaccination use and sources and determine the local and county hospital epidemiology, burden and course of influenza hospitalization.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

CREST Study

Using novel molecular beacons to study the impact of carbapenem resistant Enterobacteriaceae (CRE) carriage on the outcomes of solid organ transplantation.

Description

To determine CRE rates in solid organ transplant recipients at time of transplant and post-transplant.  The project will also determine associations between CRE colonization, CRE infections and outcomes like length of hospital stay, and rates of mortality, rejection and allograft failure.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

IRC-005 Project

A Randomized Double-Blind, Phase 3 Study Comparing the Efficacy and Safety of High-Titer versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A.

Description

To Evaluate the efficacy of treatment with high-titer versus low-titer anti-influenza immune plasma as an addition to standard care in subjects hospitalized with severe influenza A by clinical status at Day 7.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

CORE Project

Evaluation of Diagnostic Laboratory Testing.

Description

This study will be a clinical research repository bank containing blood, urine, bronchoalveolar lavage samples, tissue, fungal isolates and other samples and corresponding clinical information that characterizes the samples that will provide investigators with necessary data to improve the diagnosis of fungal infections, increase the understanding of the determinants of fungal infections, the role of host defenses, and predictors of treatment outcomes which may lead to improved treatment modalities.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

IA Study

Candida albicans gene expression during intra-abdominal infections.

Description

The study will determine the incidence of intra-abdominal infections, risk factors, clinical manifestations, microbiology, treatment options and outcomes. The ultimate objective is to determine the usefulness (specifically sensitivity, specificity and PPV and NPV) of the Candida pcr from blood for diagnosis of intra-abdominal infection.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

CAPSIL Study

Prophylaxis versus Preemptive Therapy for the Prevention of CMV in High-Risk R-D+ Liver Transplant Recipients.
Also known as 'CAPSIL' [CMV Antiviral Prevention Strategies In R-D+ Liver Transplants].

Description

The study will compare prophylaxis versus preemptive therapy using valganciclovir for the prevention of CMV disease in R-/D+ liver transplant recipients.    Clinical outcomes (major bacterial, fungal and non-CMV viral infections, rejection, graft loss and mortality will be evaluated.  In addition, the project will also assess the two preventive strategies for:  The development of CMV-specific immunity following transplantation and cost effectiveness of the regimens.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

FMT Project

Registry for Fecal Microbiome Transplant (FMT) for Recurrent Clostridium difficile Infection (CDI) at UPMC.

Description

The project will evaluate Evaluate incidence of CDI (Clostridium difficile Infection) status post FMT intervention (negative after FMT or if the patient remains positive), analyze the FMT procedure for improved or worse outcomes, quality of life, and rehospitalizations related to CDI post FMT and evaluate the characteristics of these patients that undergo the FMT procedure and those subjects who have donated feces for the FMT procedure.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

Isavuconazole PK Study

Efficacy and safety of Isavuconazole prophylaxis among organ transplant recipients.

Description

The purpose of this study is to evaluate the amount of Isavuconazole in the bloodstream when the organ transplant patients receive a standard dose of Isavuconazole and what factors contribute to the variability in blood levels of this drug in organ transplant patients.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

INSIGHT Study

An International Observational Study to Characterize Post-transplant Adults Treated for Clostridium difficile Infections (CDIFF STUDY).

Description

The purpose of the study is to estimate the response to physician determined antibiotic treatment for CDI (Clostridium difficile Infections) up to 90 days post treatment to determine outcomes, relapse, re-hospitalization, complications, characteristics of the population, and rates of cure.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu

Title

Microbiome Study

Microbiome and host response signatures for pneumonia among lung transplant recipients.

Description

The project will identify microbiome and cytokine signatures of pneumonia, tracheobronchitis and colonization in lung transplant recipients and to validate microbiome and cytokine signatures of pneumonia, tracheobronchitis and colonization in lung transplant recipients.

Contact Info

Telephone: 412-648-6553
Fax: 412-648-6399
Postal Address:
Falk Medical Bldg.
3601 Fifth Ave., Suite 3A
Pittsburgh, PA 15213
E-mail (general info): Diana Lynn Pakstis- dlp5@pitt.edu