The IGNITE 1 trial evaluated the efficacy and safety of eravacycline
in 512 patients with complicated intra-abdominal infection. Eravacycline is a synthetic fluorocycline antibiotic similar in structure to tigecycline, which inhibits bacterial protein synthesis and which has broad-spectrum activity. A high rate of cure was achieved, similar to the comparator (ertapenem).
, a bactericidal diaminopyrimidine that is active against gram-positive bacteria and which has orphan drug designation for Staphylococcus aureus
respiratory tract infections in people with cystic fibrosis. It is also being evaluated for acute bacterial skin and skin structure (ABSSI) infections in the recently closed REVIVE I and II trials and was compared to vancomycin in a randomized phase 2 trial of nosocomial pneumonia involving 70 patients. Significantly better cure rates were evident for 2 dosing regimens compared to vancomycin in the phase 2 setting.
Other trials of note involved the demonstration of protective activity against Clostridium difficile
infection of the human monoclonal antibodies actoxumab and bezlotoxumab in 3 trials, the efficacy of omadacycline
against ABSSI and against pneumonia in the community setting in the OASIS-2 and OPTIC trials, respectively, and the prowess of meropenem-vaborbactam
in TANGO-I and -II. Still, other trials are recruiting or will be shortly. These include RESTORE-IMI 1 (NCT02452047), RESTORE-IM 2 (NCT02493764), LEAP 1 (NCT02559310), LEAP 2 (NCT02813694), PERIFOS (NCT03235947), and PROOF (NCT03260010).
Shifting gears one last time, recent notable trials in mycology were discussed by Thomas Patterson, MD, University of Texas Health Science Center at San Antonio and South Texas Veterans Health Care System, San Antonio, Texas. The gamut of trials included new agents for aspergillosis and mucormycosis (single-arm, open-label VITAL trial), Aspergillus and mold treatment strategies including combination therapy and prophylaxis (isavuconazole versus voriconazole; phase 3 SECURE trial), cryptococcal meningitis in HIV infection (fluconazole in combination with flucytosine or amphotericin B; adjuvant dexamethasone; adjuvant corticosteroid) and endemic fungi,
candidiasis (isavuconazole versus caspofungin; ACTIVE trial), and monitoring and management of toxicity of therapeutic drugs.
A novel development is the formulation of itraconazole using a proprietary technology dubbed SUBA (SUperBioAvailable) in which spray drying creates nanoparticle of itraconazole in a polymer matrix. Delayed released posaconazole has been studied in patients at high risk of fungal infections.
These and other trial results are available at www.msgercdoctorfungus.com.
Francisco Marty: Astellas Pharma US: Consultant and Grant Investigator, Consulting fee and Grant recipient Chimerix: Consultant and Grant Investigator, Consulting fee and Grant recipient
Fate Therapeutics: Scientific Advisor, Consulting fee Gilead Sciences: Consultant and Grant Investigator, Consulting fee and Grant recipient LFB: Consultant, Consulting fee
Merck: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Grant recipient Roche Molecular Systems: Consultant, Consulting fee Shire: Consultant and Grant Investigator, Consulting fee and Grant recipient
Susan J. Rehm: Amgen: Shareholder, dividend Merck: Shareholder, dividend Pfizer: Consultant and Shareholder, Consulting fee and dividend
Thomas Patterson: Astellas: Consultant, Consulting fee Basilea: Consultant, Consulting fee Gilead: Consultant, Consulting fee Merck: Consultant, Consulting fee Scynexis: Consultant, Consulting fee Toyama: Consultant, Consulting fee
SYMPOSIUM New Anti-Infective Clinical Trials that Will Change Your Practice
Recent Trials in Non-HIV Antivirals
Francisco M. Marty, MD, Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA
Recent Trials in Antibacterials
Susan J. Rehm, MD, Cleveland Clinic, Cleveland, OH
Recent Trials in Antifungals
Thomas Patterson, MD, University of Texas Health Science Center At San Antonio and South Texas Veterans Health Care System, San Antonio, TX
Brian Hoyle, PhD, is a medical and science writer and editor from Halifax, Nova Scotia, Canada. He has been a full-time freelance writer/editor for over 15 years. Prior to that, he was a research microbiologist and lab manager of a provincial government water testing lab. He can be reached at firstname.lastname@example.org.
To stay informed on the latest in infectious disease news and developments, please sign up for our weekly newsletter.