RecruitingNot ApplicableNCT06051513

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

Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection:a Prospective, Open-label, Randomized Controlled, Multicenter Clinical Trial


Sponsor

Southeast University, China

Enrollment

404 participants

Start Date

Nov 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Colistin can be used to treat the infection caused by carbapenem-resistant enterobacteriaceae(CRE). In China, patients diagnosed with Hospital-acquired-pneumonia (HAP)or bloodstream infection caused by CRE are recruited, and randomly assigned to two groups, and in one group the patients accept treatment with colistin, however in another group, the patients accept treatment without colistin. The efficacy and safety of the treatment between the two groups are compared.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called treatment with or without colistin for people with carbapenem-resistant enterobacteriaceae infection. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtreatment with or without colistin

For patients in this treatment group, colistin based therapy is used. Colistin combined with metroperan or imipenem(MIC≤8mg/L),or colistin combined with tigecycline, or colistin combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae. For patients in the control, best available treatment without colistin is uesed; Ceftazidime-avibactam, tigecycline combined with metroperan or imipenem(MIC≤8mg/L), tigecycline combined with aminoglycosides (amikacin) are suggested to treat patients diagnosed with hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae.


Locations(15)

Anhui Provincial People's Hospital

Hefei, Anhui, China

The First Hospital of Anhui Medical University

Hefei, Anhui, China

Jinjiang Municipal Hospitall

Jinjiang, Fujian, China

Huai'an First People's Hospital

Huai'an, Jiangsu, China

The First Hospital of Lianyungang

Lianyungang, Jiangsu, China

Zhongda Hospital Affiliated to Southeast University

Nanjing, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Suzhou Municipal Hospitial

Suzhou, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

JiangsuTaizhou People's Hospital

Taizhou, Jiangsu, China

Wuxi No.2 People's Hospital

Wuxi, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Yancheng No.1 People's Hospital

Yancheng, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Yixing People's Hospital

Yixing, Jiangsu, China

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NCT06051513


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