Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial

Cornely, Oliver A.; Kullberg, Bart Jan; Kollef, Marin H.; Bassetti, Matteo; Dignani, Cecilia; Das, Anita; Sandison, Taylor; Pappas, Peter G.; Akova, Murat; AlAgha, Rawan; Alangaden, George; Albrecht, Svenja; Alexander, Barbara; Al-Obaidi, Mohanad; Ambasch, Germán; Rodriguez, Fernando Armestar; Azap, Alpay; Baffoe-Bonnie, Anthony; Belkhir, Leïla; Ben‐Ami, Ronen; Boutoille, David; Cascio, Antonio; Chai, Louis YA; Chaiwarith, Romanee; Chayakulkeeree, Methee; Chen, Sharon; Chen, Yee‐Chun; Chen, Yen-Hsu; Choi, Jun Yong; Choi, Young Hwa; Chotiprasitsakul, Darunee; Chung, Jin-Won; Danion, François; Denis, Blandine; Santos, E Díaz; Dictar, Miguel O; Diltoer, Marc; Dupont, Hervé; Feng, Sizhou; Colomer, Maria Angeles Ferre; Ferrer, Ricard; Forel, Jean-Marie Fernand Roger; Fortún-Abete, Jesús; Garcia‐Diaz, Julia; Girardis, Massimo; He, Fei; Hites, Maya; Ho, Mao‐Wang; Honoré, Patrick M.; Gallego, Juan Pablo Horcajada; Huang, Haihui; Huang, Po-Yen; Huo, Yong; Hussein, Osamah; Intalapaporn, Poj; Jaruratanasirikul, Sutep; Jáuregui-Peredo, Luis; Johnson, Misty; Jung, Dong Sik; Jutivorakool, Kamonwan; Kern, Winfried V.; Kett, Daniel H.; Khawcharoenporn, Thana; Kim, Young Keun; Köehler, Philipp; Κοτανίδου, Αναστασία; Lachiewicz, Anne; Lin, Qinhan; Cortés, Luis Eduardo López; Luo, Hong; Luzzati, Roberto; Maor, Yasmin; McCarty, Todd P; Merelli, Maria; Amador, Paloma Merino; Midturi, John; Migliorino, Guglielmo Marco; Mira, Jean‐Paul; Mootsikapun, Piroon; Morrissey, Orla; Paredes, Patricia Munoz Garcia de; Mussini, Cristina; Mylonakis, Eleftherios; Nseir, Saadalla; Nseir, William; Odabaşı, Zekaver; Papastamopoulos, Vasileios; Paterson, David L.; Patterson, Thomas F.; Peck, Kyong Ran; Peng, Zhiyong; Permpalung, Nitipong; Plantefève, Gaëtan; Poromanski, Ivan G; Powell, D. C.; Psichogiou, Mina; Puah, Ser Hon; Pullman, John; Rahav, Galia; Martínez, Antonio Ramos; Ramos, Juan Carlos Ramos; Raz-Pasteur, Ayelet; Castro, Carlos A Restrepo; Riera, Fernando; Roblot, F.; Alvarez, Regino Jose Rodriguez; Rogers, Benjamin A.; Roilides, Emmanuel; Vallejo, Gregorio Sánchez; Sganga, Gabriele; Sipsas, Nikolaos V.; Slavin, Monica; Soriano, Álex; Spec, Andrej; Strahilevitz, Jacob; Tancheva, Dora M; Zuyi, Tao; Teschner, Daniel; Thompson, George R.; Wijngaerden, Eric Van; Vázquez, José Antonio; Vergidis, Paschalis; Viale, Pierluigi; Wang, Fu‐Der; Wang, Shifu; Weber, Gabriel; Weng, Jianyu; Xu, Jie; Li, Yao; Yavuz, Serap Şimşek; Yılmaz, Mesut; Young, Jo‐Anne H.; Zarate, Abel H; Zeng, Jun; Zhang, Yong

doi:10.1016/s0140-6736(22)02324-8

Cited by 55 publications

(28 citation statements)

References 26 publications

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“…In addition, a new viable strategy is passive immunization with monoclonal antibodies, so as to strengthen the host antifungal immune response [ 41 , 42 ], particularly in immunocompromised patients who are more prone to systemic fungal infections. Finally, three novel antifungal agents, currently in phase II/III clinical trials, might have an important role for the treatment of invasive candidiasis: phase III results showed the efficacy and safety of rezafungin [ 43 ], a novel echinocandin with extended half-life (once-weekly intravenous administration), enhanced tissue penetration/residence time, and limited drug–drug interaction potential; ibrexafungerp (phase III clinical trials) and fosmanogepix are two first-in-class antifungal drugs with acceptable oral bioavailability and broad-spectrum activity against Candida spp., including C. auris and echinocandin-resistant species ( Table 2 ) [ 43 , 44 ]. These three compounds, together with other new products, i.e., VT-1598 and ATI-2307, were found to be effective against candidemia due to C. auris [ 38 ].…”

Section: New Antifungal Agentsmentioning

confidence: 99%

Antifungal Drug Resistance: An Emergent Health Threat

Vitiello

Ferrara²,

Boccellino

et al. 2023

Biomedicines

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Fungal infections, named mycosis, can cause severe invasive and systemic diseases that can even lead to death. In recent years, epidemiological data have recorded an increase in cases of severe fungal infections, caused mainly by a growing number of immunocompromised patients and the emergence of fungal pathogenic forms that are increasingly resistant to antimycotic drug treatments. Consequently, an increase in the incidence of mortality due to fungal infections has also been observed. Among the most drug-resistant fungal forms are those belonging to the Candida and Aspergillus spp. Some pathogens are widespread globally, while others are endemic in some areas only. In addition, some others may represent a health threat for some specific subpopulations and not for the general public. In contrast to the extensive therapeutic armamentarium available for the antimicrobial chemotherapeutic treatment of bacteria, for fungal infections there are only a few classes of antimycotic drugs on the market, such as polyenes, azoles, echinocandins, and a few molecules are under trial. In this review, we focused on the systemic mycosis, highlighted the antifungal drug compounds available in the pipeline, and analyzed the main molecular mechanisms for the development of antifungal resistance to give a comprehensive overview and increase awareness on this growing health threat.

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Section: New Antifungal Agentsmentioning

confidence: 99%

Antifungal Drug Resistance: An Emergent Health Threat

Vitiello

Ferrara²,

Boccellino

et al. 2023

Biomedicines

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“…Therefore, the development of new antifungals and more clinical studies are urgently needed. Recently, some progress has been made with promising new drug candidates for the treatment of invasive fungal infections, such as Fosmanogepix and Rezafungin [ 19 , 20 ]. Fosmanogepix is a Gwt1 enzyme inhibitor with a novel mechanism of action and good (oral) bioavailability [ 19 ].…”

Section: Discussionmentioning

confidence: 99%

Nakaseomyces glabrata endocarditis: A therapeutic dilemma

Jim

Daems

Boekholdt

et al. 2023

Medical Mycology Case Reports

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“…Rezafungin is a novel echinocandin with a long elimination half-life (~133 h), allowing for once-weekly dosing. Recently published results of a phase 3 clinical trial have shown non-inferiority compared with caspofungin for the treatment of candidemia and invasive candidiasis [ 150 ]. Echinocandins are recommended by IDSA and ESCMID guidelines as first-line treatment of invasive candidiasis and candidemia [ 151 , 152 , 153 ].…”

Section: Echinocandinsmentioning

confidence: 99%

Systemic Antifungal Therapy for Invasive Pulmonary Infections

Ben‐Ami

2023

JoF

Self Cite

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Antifungal therapy for pulmonary fungal diseases is in a state of flux. Amphotericin B, the time-honored standard of care for many years, has been replaced by agents demonstrating superior efficacy and safety, including extended-spectrum triazoles and liposomal amphotericin B. Voriconazole, which became the treatment of choice for most pulmonary mold diseases, has been compared with posaconazole and itraconazole, both of which have shown clinical efficacy similar to that of voriconazole, with fewer adverse events. With the worldwide expansion of azole-resistant Aspergillus fumigatus and infections with intrinsically resistant non-Aspergillus molds, the need for newer antifungals with novel mechanisms of action becomes ever more pressing.

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Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial

Cited by 55 publications

References 26 publications

Antifungal Drug Resistance: An Emergent Health Threat

Antifungal Drug Resistance: An Emergent Health Threat

Nakaseomyces glabrata endocarditis: A therapeutic dilemma

Systemic Antifungal Therapy for Invasive Pulmonary Infections

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