HIPAA Compliant
ISO 27001 CertifiedActively Recruiting
Led by Southeast University, China · Updated on 2025-05-18
404
Participants Needed
15
Research Sites
N/A
Total Duration
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.
CONDITIONS
Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection
Y
Yingzi Huang, MD
J
Jianfeng Xie, MD
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Southeast University, China
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days from randomization
Participants receive treatment with or without colistin to treat carbapenem-resistant Enterobacteriaceae infection. Treatment includes intravenous medications such as colistin combined with other antibiotics or best available therapy without colistin.
Daily treatment visits during 14 days
Duration - Up to 90 days after randomization
Participants are monitored for safety and outcomes including mortality, clinical cure, and adverse events up to 90 days after randomization.
Visits up to 90 days post-treatment for outcome assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Xiangquan Li, Chen Zhang, Jiaqiong Li...
https://pubmed.ncbi.nlm.nih.gov/40669898/Southeast University, China
Lead Sponsor
