An introduction to the prospective antifungal therapy alliance (PATH AllianceÂ®)
Description: The PATH Alliance is a network of centers contributing to a long-term, prospective, clinical surveillance program. All patients diagnosed with invasive fungal infection (IFI) are eligible, regardless of antifungal treatment strategy or underlying disease. Objective: The objective of the PATH Alliance is to establish a real-time clinical database reflecting routine clinical management of patients diagnosed with IFI. It will enable monitoring of trends in epidemiology, diagnosis, treatment, and outcomes. This program will also support clinicians in evaluating treatment strategies, developing treatment paradigms, and planning clinical trials. Program Development: The PATH Alliance was developed collaboratively by the program sponsor (Fujisawa Healthcare, Inc.) and an independent Scientific Advisory Board. This Board actively participated in developing the protocol, electronic case report form (e-CRF), and reports. The authorship list reflects Board membership. Data collection is ongoing at 6 sites in the United States, with several more sites in the United States and Canada set to begin. Additional sites will be phased in over the coming months. Methods: Patients are eligible upon diagnosis of proven or probable IFI. These definitions were adapted from the International Consensus Guidelines (Ascioglu S, et al. Clin Infect Dis 2002;34:7-14) by the Scientific Advisory Board to accommodate a broader patient population. Patient data are captured prospectively over a 12-week follow-up period using a Web-based e-CRF. These data include i) assessment at diagnosis of IFI (demographics, risk factors, details of underlying disease, and specifics of the IFI); ii) systemic antifungal therapy received over the 12-week follow-up; and iii) outcome assessment at 12 weeks (patient disposition, status of fungal infection, and assessment of underlying disease). Patients who die or are lost to follow-up (eg, patients discharged home or to another institution) prior to the 12-week follow-up are assessed at time of death or last known status, respectively. Participants have access via the Internet to view their site-specific data or the aggregate data through a wide variety of reports that were designed by the Scientific Advisory Board to provide clinically relevant information. Reports are generated dynamically; thus, they always reflect the most current set of complete patient records. In addition, users have the flexibility to customize reports to focus on specific types of patients. Results: To date, 36 patients have been enrolled. They include general medicine (11), surgical (9), hematologic malignancy (8), solid tumor (5), and solid organ transplant (3) patients. The majority of the 43 IFI diagnoses were Candida (38); others include Aspergillus (3), Cryptococcus (1), and Zygomycetes (1). Updated results will be presented at the conference. Conclusions: There is an urgent need for new sources of clinical information relevant to the management of patients with IFI. The PATH Alliance provides a unique complement to randomized, controlled trials, offering increased understanding of changing patterns in the fungal landscape across a broad geographic area. These capabilities are particularly relevant for rare pathogens and combination therapy topics difficult to study in a clinical trial setting. As enrollment continues, results will be regularly shared with the infectious disease community.
Full conference title:
15th Annual Focus on Fungal Infections