Study of Colistimethate Sodium Injection for Treating Carbapenem-Resistant Enterobacteriaceae Infections in Hospital-acquired Pneumonia or Bloodstream Infection

What this Trial Is About

Researchers are evaluating the use of colistin in treating infections caused by carbapenem-resistant enterobacteriaceae CRE, specifically in patients with hospital-acquired pneumonia HAP or bloodstream infections in China. This study compares the effectiveness and safety of treatments with and without colistin to understand how well colistin works and its safety profile in these serious infections. The study follows good clinical practice and ethical guidelines, recruiting patients from 14 centers in China. Patients will be randomly assigned to one of two groups. One group will receive colistin-based therapy combined with other antibiotics such as meropenem, tigecycline, or amikacin. The colistin dose starts with a loading dose followed by maintenance doses given intravenously twice daily. The other group will receive the best available treatment without colistin, including combinations of antibiotics like ceftazidime-avibactam, tigecycline, meropenem, imipenem, or amikacin. Treatment duration and doses are specified for each drug. Participants will be monitored for outcomes including 14-day all-cause mortality, clinical cure rates, infection clearance, ICU-free days, and adverse events during and after treatment. The study includes follow-up assessments up to 90 days post-randomization to evaluate hospital and ICU mortality. Safety and efficacy will be measured through clinical evaluations, microbiological tests, and adverse event tracking. The total participation time varies depending on follow-up duration and clinical course.

Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection