Open Access<p>No Evidence for Ceftobiprole-Induced Immune Hemolytic Anemia in Three Phase 3 Clinical Trials</p>
Author(s) -
Kamal Hamed,
Tatiana Wiktorowicz,
Maziar Assadi Gehr
Publication year - 2020
Publication title -
infection and drug resistance
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.033
H-Index - 39
ISSN - 1178-6973
DOI - 10.2147/idr.s268269
Subject(s) - medicine , daptomycin , adverse effect , anemia , clinical trial , randomized controlled trial , gastroenterology , staphylococcus aureus , vancomycin , biology , bacteria , genetics
Drug-induced immune hemolytic anemia (DIIHA) is a rare but serious adverse event associated with a number of drugs, including second- and third-generation cephalosporins. A positive direct antiglobulin test (DAT) is a reliable finding in DIIHA, but positive results without evidence of hemolysis can occur, particularly in hospitalized patients. There have been no reports of hemolytic anemia in four previous Phase 3 trials or from post-marketing surveillance of the advanced-generation, broad-spectrum cephalosporin, ceftobiprole. The aim of this analysis was to review the incidence of positive DAT results and any evidence of hemolytic anemia from three recent Phase 3 trials of ceftobiprole.