Actively Recruiting
Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection
Led by Southeast University, China · Updated on 2025-05-18
404
Participants Needed
15
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who can provide written informed consent or have a legal guardian to provide consent
- Hospitalized patients
- Adults aged 18 to 85 years
- Suspected or diagnosed hospital-acquired pneumonia (HAP) or bloodstream infection caused by carbapenem-resistant enterobacteriaceae based on culture or rapid diagnostic tests within 5 days before randomization
- Patients with HAP must have fever or hypothermia and at least two respiratory signs or symptoms such as new or worsening cough, purulent sputum, lung sounds consistent with pneumonia, or breathing difficulties
- Patients with bloodstream infection must have fever, chills, or low blood pressure and CRE isolated from at least two blood cultures from different sites
- Respiratory or blood specimens obtained for culture after symptoms onset and before antibiotics when possible
- APACHE II score between 10 and 30
You will not qualify if you...
- Use of polymyxin antibiotics for more than 48 hours within 72 hours before randomization
- Use of other antibiotics for more than 24 hours within 72 hours before randomization with patient improvement after treatment
- History of serious allergy or severe reaction to colistimethate sodium or its ingredients
- Active concurrent pneumonia caused by specified bacteria or viruses unless deemed not affecting prognosis
- Diagnosis of primary lung cancer or other malignancy with lung involvement or certain lung infections like tuberculosis or abscess
- Hematological malignancies such as leukemia, lymphoma, or multiple myeloma
- History of lung, heart, or stem cell transplantation
- Immunocompromised status including HIV with low CD4 count, recent chemoradiotherapy, immunosuppressive therapy, or very low neutrophil count
- Chronic liver failure with portal hypertension or acute liver failure
- Participation in other clinical trials within 3 months
- Pregnancy or breastfeeding with positive pregnancy test
- Previous enrollment in this study
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Anhui Provincial People's Hospital
Hefei, Anhui, China, 230000
Actively Recruiting
2
The First Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Actively Recruiting
3
Jinjiang Municipal Hospitall
Jinjiang, Fujian, China, 362200
Actively Recruiting
4
Huai'an First People's Hospital
Huai'an, Jiangsu, China, 223000
Actively Recruiting
5
The First Hospital of Lianyungang
Lianyungang, Jiangsu, China, 222000
Actively Recruiting
6
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
7
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226000
Actively Recruiting
8
Suzhou Municipal Hospitial
Suzhou, Jiangsu, China, 215000
Actively Recruiting
9
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
10
JiangsuTaizhou People's Hospital
Taizhou, Jiangsu, China, 225300
Actively Recruiting
11
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China, 214000
Actively Recruiting
12
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
13
Yancheng No.1 People's Hospital
Yancheng, Jiangsu, China, 224000
Actively Recruiting
14
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225000
Actively Recruiting
15
Yixing People's Hospital
Yixing, Jiangsu, China, 214000
Actively Recruiting
Research Team
Y
Yingzi Huang, MD
CONTACT
J
Jianfeng Xie, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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