Clinical Studies for Infectious Disease

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Title: A Prospective Randomized Basket Trial Evaluating the Clinical Utility of Plasma-Based Microbial Cell-Free Metagenomic Sequencing for Infection Diagnosis in Adult Immunocompromised Outpatients
Brief Title: Optimum
Brief Summary: This clinical trial is designed to evaluate if adding the Karius Spectrumâ„¢ plasma test to usual care diagnostic tests, compared to usual care testing alone, among immunocompromised participants presenting with suspected infection in the outpatient setting leads to faster infection diagnosis and treatment. Participants will give a blood sample one time to be used for the testing. Information about the participant's illness and any treatments within 30 days following enrollment will be recorded.
For info regarding 2025P000549 please contact Aliyyah Catyb at acatyb@bidmc.harvard.edu
 
Title: Clinical Validation of the NeXGen Fungal/AFB NGS Test for Diagnosis of Invasive Mold Disease (IMD) in Immunocompromised Hosts
Brief Title: Validation of NeXGen Fungal Test for IMD
Brief Summary: The purpose of this study is to validate the efficacy and validity of a new type of invasive mold disease test in patients who are immunocompromised. A one-time blood draw will be collected from subjects while they are at the hospital for an inpatient admission or outpatient visit.
For info regarding 2024P000982 please contact Audrey Mahajan at 617-632-0827 or amahaja1@bidmc.harvard.edu
 
Title: Linking HIV Prevention and Postpartum Care: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a High-Risk Breastfeeding Population in Botswana
Brief Title: Tshireletso
Brief Summary: The goal of this this hybrid safety/implementation study is to evaluate whether using long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe in post-partum people who are breastfeeding. The main question[s] it aims to answer are: - Will CAB-LA injections work well as a way to prevent HIV infection in post-partum people? - Will CAB-LA injections be safe in post-partum people and their infants who will be breastfeeding? Participants without HIV who are admitted to the maternity ward after having delivered a baby will be offered to start CAB-LA PrEP. Those who choose to participate will receive their first dose (injection) at the maternity ward and their follow up doses (injections) at their local clinic when they come for routine post-partum and pediatric care. Participants and their infants will be followed in the study for 24 months. We will be following how many people come on-time for their CAB-LA injections, how often they keep coming back, and the reasons they continue (or stop) these injections. We will also test people for HIV at all of their visits to see how many people get HIV during the study. We will also measure the levels of the medication in the blood of the post-partum people and their infants (who may be getting some of the CAB-LA in breastmilk) and evaluate to see if their is any impact of CAB-LA on the health of the post-partum person or their infants.
For info regarding 2023P000415 please contact Rebecca Zash at 617-632-7706 or rzash@bidmc.harvard.edu