Clinical Research Directory

Antimicrobial Stewardship Program Implementation in Brazilian Public Hospitals (PeGASUS)

Antimicrobial resistance is a major global public health challenge, leading to increased morbidity, mortality, and healthcare costs. Antimicrobial Stewardship Programs (ASPs) are recognized as an effective strategy to improve the appropriate use of antimicrobials and to reduce the emergence of resistant microorganisms. However, despite national guidelines, many hospitals-especially in low- and middle-income settings-face important barriers to implementing and sustaining these programs. The PeGASUS study is a nationwide, multicenter implementation initiative designed to support and strengthen ASPs in Brazilian public hospitals. The study will include approximately 54 hospitals across all five regions of Brazil that either do not have an ASP or have programs classified as inadequate or basic. This is a pragmatic, quasi-experimental before-and-after study with historical control, conducted over approximately 21 months. The intervention combines multiple strategies to address common implementation barriers, including a structured web-based training program, engagement of hospital leadership, development of locally tailored ASP action plans, ongoing technical support, and collaborative learning between participating hospitals. The study is organized into four phases: (1) pre-intervention (baseline), (2) intervention, (3) follow-up, and (4) wrapping up. During the baseline phase, data on hospital characteristics, antimicrobial use, and ASP organization are collected. During the intervention phase, hospitals receive training and support to implement ASP activities adapted to their local context. The follow-up phase evaluates the sustainability of the implemented strategies under routine conditions. Outcomes include changes in the level of ASP implementation, antimicrobial consumption (measured as defined daily doses per 1,000 patient-days), number and acceptance of stewardship interventions, and clinical outcomes such as length of hospital stay and 30-day mortality. Additionally, a cost-effectiveness analysis will be conducted in a subset of hospitals. All data are collected at the hospital level in aggregated form, without identifying individual patients, ensuring confidentiality and minimizing risks. By combining capacity building, standardized tools, and continuous support, the PeGASUS study aims to bridge the gap between national antimicrobial stewardship guidelines and real-world practice. The findings are expected to provide evidence on scalable strategies to improve antimicrobial use and strengthen healthcare systems, particularly in resource-limited settings.

TB-CAPT MTB/XDR Study

The Cepheid Xpert MTB/XDR cartridge, which runs on the same platform as Xpert MTB/RIF Ultra, has been developed to detect additional resistance to isoniazid, fluoroquinolones and second-line injectable anti-tuberculosis drugs and provides results within 2 hours and on primary samples. An evaluation of the the Xpert MTB/XDR assay is currently underway in clinical settings in South Africa, India and Moldova. The TB-CAPT MTB/XDR Study will add further diagnostic accuracy and feasibility data to the evidence base for the Xpert MTB/XDR assay.

Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)

Colonization by Multiple Drug Resistant Organisms (MDROs) during patient hospitalization requires expensive isolation measures and renders the return or transfer to other departments or institutions often impossible. Currently there is no specific treatment available. Patients have to wait for spontaneous clearance which can take months or does not happen at all. The study will test the effect of Fecal Microbiota Transfer (FMT) on gut MDRO colonization. The focus will be on patients with a long-term colonization by Gram-negative bacteria for which isolation is warranted. Participants will be randomized into two treatment groups; allogenic FMT versus autologous FMT. A third group of participants will be monitored but will not receive an FMT. Decolonization rate will be compared one month after treatment. Additionally gut microbial composition will be studied up to one year after FMT.

Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections

This study aims to validate a novel antibiotic susceptibility test (InSignia) for gonorrhoea in patient clinical samples. The hypothesis is that the InSignia test will be able to detect transcriptional responses after incubation in antibiotic for susceptible strains and not resistant strains. Furthermore, this study will also add to our understanding on the performance of this test in various clinical specimens.