ACCELENA R&D has completed patient enrollment for a Phase II trial of an antimicrobial agent developed by the Gamaleya Research Center of Epidemiology and Microbiology. The study focuses on preventing nosocomial bacterial infections in mechanically ventilated patients, with 234 subjects enrolled.
Conducted under an agreement with the Moscow Department of Healthcare, this double-blind, multicenter, randomized, placebo-controlled trial evaluated the prophylactic use of Fluorothiazinone in ICU patients with community-acquired viral pneumonia, stroke (acute cerebrovascular accident), or acute heart failure (AHF). The primary objective was to assess efficacy in preventing ventilator-associated pneumonia (VAP) caused by Gram-negative bacteria.
«This trial involved an original domestic antibacterial agent – the first registered in Russia in 70 years. Its mechanism of action fundamentally differs from antibiotics, enabling prophylactic use while suppressing pan-resistant nosocomial pathogens. We hope these results advance clinical application and combat global antibiotic resistance. We thank ACCELENA R&D’s highly professional team for their work on this complex, ambitious project,» – Nailya Akhatovna Zigangirova, MD, Chief Researcher, Gamaleya National Research Center.
Due to slow initial enrollment (limited eligible patients), a protocol amendment expanded inclusion criteria to allow randomization of any diagnosis requiring mechanical ventilation. This accelerated recruitment: >80% of participants were enrolled within 12 months post-amendment. The study ran from October 2022 to July 2025 across 12 sites in Moscow and St. Petersburg.
«Intensive care trials remain underrepresented. As Principal Investigator, I’m proud our center advances this field. Our team’s synergy with ACCELENA R&D facilitated the drug’s market progression, creating new patient opportunities,» – Boris Shakh, MD, PhD, Professor, Principal Investigator, City Hospital No. 2, St. Petersburg.
Given patients’ critical condition, an enhanced safety analysis approach was implemented, including regular Safety Review Board meetings with PIs and timely/accurate adverse event (AE) reporting.
«Despite challenges, this remains my favorite project – fascinating and impactful. Our Project Lead Yulia Senatova inspired the team. Working with real-world patients provided unparalleled safety insights unmatched in other trials. I now seek all intensive care studies; they’re the most ‘alive’ and authentic!» – Rimma Sharipova, Senior Clinical Research Specialist, ACCELENA R&D.
ACCELENA R&D is fully responsible for the organization and management of the trial. The team handles medical writing, logistics, interaction with ethics committees, clinical sites support, staff training, monitoring visits, data management, biostatistics, and preparation of a final report.
Leveraging expertise in late-phase trials involving critically ill patients, ACCELENA R&D has established itself as a reliable partner for high-complexity clinical projects. The team excels in ICU settings,maintaining operational resilience under stress, challenging patient recruitment, and tight timelines. Theirflexibility, expertise, and accountability ensure protocol compliance and ethical standards while achieving project goals.
Conducted under an agreement with the Moscow Department of Healthcare, this double-blind, multicenter, randomized, placebo-controlled trial evaluated the prophylactic use of Fluorothiazinone in ICU patients with community-acquired viral pneumonia, stroke (acute cerebrovascular accident), or acute heart failure (AHF). The primary objective was to assess efficacy in preventing ventilator-associated pneumonia (VAP) caused by Gram-negative bacteria.
«This trial involved an original domestic antibacterial agent – the first registered in Russia in 70 years. Its mechanism of action fundamentally differs from antibiotics, enabling prophylactic use while suppressing pan-resistant nosocomial pathogens. We hope these results advance clinical application and combat global antibiotic resistance. We thank ACCELENA R&D’s highly professional team for their work on this complex, ambitious project,» – Nailya Akhatovna Zigangirova, MD, Chief Researcher, Gamaleya National Research Center.
Due to slow initial enrollment (limited eligible patients), a protocol amendment expanded inclusion criteria to allow randomization of any diagnosis requiring mechanical ventilation. This accelerated recruitment: >80% of participants were enrolled within 12 months post-amendment. The study ran from October 2022 to July 2025 across 12 sites in Moscow and St. Petersburg.
«Intensive care trials remain underrepresented. As Principal Investigator, I’m proud our center advances this field. Our team’s synergy with ACCELENA R&D facilitated the drug’s market progression, creating new patient opportunities,» – Boris Shakh, MD, PhD, Professor, Principal Investigator, City Hospital No. 2, St. Petersburg.
Given patients’ critical condition, an enhanced safety analysis approach was implemented, including regular Safety Review Board meetings with PIs and timely/accurate adverse event (AE) reporting.
«Despite challenges, this remains my favorite project – fascinating and impactful. Our Project Lead Yulia Senatova inspired the team. Working with real-world patients provided unparalleled safety insights unmatched in other trials. I now seek all intensive care studies; they’re the most ‘alive’ and authentic!» – Rimma Sharipova, Senior Clinical Research Specialist, ACCELENA R&D.
ACCELENA R&D is fully responsible for the organization and management of the trial. The team handles medical writing, logistics, interaction with ethics committees, clinical sites support, staff training, monitoring visits, data management, biostatistics, and preparation of a final report.
Leveraging expertise in late-phase trials involving critically ill patients, ACCELENA R&D has established itself as a reliable partner for high-complexity clinical projects. The team excels in ICU settings,maintaining operational resilience under stress, challenging patient recruitment, and tight timelines. Theirflexibility, expertise, and accountability ensure protocol compliance and ethical standards while achieving project goals.
