Clinical Research Directory

Metagenomic Sequencing Across the Infectious Disease Risk and Care Continuum

The AXIS Network is a prospective, multicenter observational registry designed to generate real-world evidence on the use of metagenomic sequencing in clinical practice across a broad range of patient populations, infectious disease syndromes, and clinical care settings. Participants receiving routine clinical care at participating institutions may be enrolled into cohort-specific registries that evaluate how metagenomic sequencing is used for diagnostic evaluation, surveillance of high-risk populations, or longitudinal monitoring of treatment response. The study does not assign participants to any intervention, alter standard clinical care, or require study-mandated testing or treatment. Instead, it collects clinical information generated during routine care, including diagnostic testing, antimicrobial use, clinical management decisions, healthcare utilization, and clinical outcomes. The primary objective of AXIS is to evaluate how metagenomic sequencing informs clinical decision-making and is associated with downstream management and clinical outcomes. Secondary objectives include characterization of test utilization patterns, diagnostic integration, antimicrobial management decisions, healthcare utilization, and longitudinal monitoring strategies. Data collected through AXIS may also support development of predictive models and clinical decision-support tools.

RSV, Influenza, and SARS-CoV-2 Outcomes in Severely Immunosuppressed Adults

Respiratory syncytial virus (RSV), influenza, and SARS-CoV-2 are common respiratory viruses. In healthy adults they usually cause mild, cold-like illness, but in people whose immune system is severely weakened - such as people who have had a bone marrow, stem cell, or organ transplant, people being treated for cancer or blood disorders, or people taking medicines that suppress the immune system - these infections can be much more serious, sometimes spreading from the nose and throat down into the lungs and leading to hospitalization, intensive care, or death. This study looks back at medical records from a large hospital network in Buenos Aires, Argentina, covering two periods (November 2011 to March 2020, and May 2022 to December 31, 2025) to describe what happens to adults with severely weakened immune systems after they are diagnosed with RSV, influenza, or SARS-CoV-2. For each of these three viruses, researchers will separately describe how sick patients were on the day of diagnosis and again 7 and 30 days later; whether the infection spread from the upper airway down into the lungs; how often patients needed to be hospitalized or admitted to an intensive care unit; how long hospital stays lasted; and how many patients died within 30 days. The study will also look for patient characteristics - such as the type of immune weakness, low blood cell counts, or vaccination status - that are linked to worse outcomes within each virus group. The three viruses are described separately and are not statistically compared against one another. This is a review of existing medical record information only. No new tests, procedures, or treatments will be given to patients as part of the study, and no patient will be contacted; all information comes from data already collected during routine medical care. This study is conducted under a research agreement with Pfizer.

COVID-19 Booster and IIV Schedule in Immunocompromised Hosts

The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC). The main questions it aims to answer are: 1. Is co-administration of seasonal inactivated influenza vaccine (IIV) with the most up-to-date recommended COVID-19 booster dose non-inferior in inducing a 1-month peak protective humoral response against COVID-19, compared to a strategy of sequential administration of COVID-19 booster dose followed by seasonal IIV given one month later? 2. Is the administration of the most up-to-date recommended COVID-19 booster doses at 3-month intervals superior at maintaining a longer term protective humoral immune response, compared to booster doses administered at 6-month intervals? Researchers will compare (1) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 3-month interval, (2) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 3-month interval, (3) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 6-month interval, and (4) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 6-month interval to see if median neutralization capacity of patient sera is non-inferior in the co- vs. sequential administration arms at 1-month after the initial COVID-19 booster and superior in the 3-month interval arms vs. the 6-month interval arms at 12 months after the initial COVID-19 booster. These outcomes will also be compared at 2-months for question 1 and 6-months for question 2. People living with immunocompromising conditions who take part in the trial will have blood samples drawn to verify immune response, be monitored for changes in clinical events and therapies, and complete questionnaires to verify adverse effects, quality of life and economic impact.