Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID06051513

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

Led by Southeast University, China · Updated on 2025-05-18

404

Participants Needed

15

Research Sites

N/A

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who can provide written informed consent or whose legal guardian can provide consent
  • Patients who are hospitalized
  • Adults aged 18 to 85 years
  • Suspected or diagnosed hospital-acquired pneumonia or bloodstream infection caused by carbapenem-resistant enterobacteriaceae based on culture or rapid diagnostic tests
  • Respiratory or blood specimen obtained for culture within 5 days prior to randomization after symptom onset
  • Patients with APACHE II score between 10 and 30
  • Hospital-acquired pneumonia patients must have fever or hypothermia, abnormal white blood cell counts, and at least two respiratory symptoms or signs
  • Bloodstream infection patients must have fever, chills, or hypotension with CRE isolated from two blood cultures
Not Eligible

You will not qualify if you...

  • Patients who received polymyxin for more than 48 hours in the 72 hours before randomization
  • Patients who received antibiotics for more than 24 hours in the 72 hours before randomization and showed improvement
  • History of serious allergy or hypersensitivity to colistimethate sodium or its ingredients
  • Active concurrent pneumonia caused by specified pathogens requiring additional antimicrobials
  • Diagnosis of primary lung cancer, lung metastases, or known post obstructive pneumonia
  • Hematological malignancies such as leukemia, lymphoma, or multiple myeloma
  • History of lung, heart, or stem cell transplantation
  • Immunocompromised patients at risk of opportunistic infections, including HIV with low CD4 count, recent chemoradiotherapy, high-dose corticosteroids, or severe neutropenia
  • Chronic liver failure or acute hepatic failure
  • Participation in other clinical trials within three months
  • Pregnant or breastfeeding women
  • Previous enrollment in this study
  • Conditions affecting trial participation or deemed unsuitable by researchers

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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

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Research Team

Y

Yingzi Huang, MD

J

Jianfeng Xie, MD

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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Published Research Related To This Trial

Multicentre open-label randomised controlled trial comparing the efficacy and safety of colistin-based combination therapy with the best available therapy for treating hospital-acquired pneumonia or bloodstream infections caused by carbapenem-resistant Enterobacteriaceae (COUNT-CRE): a study protocol.

Xiangquan Li, Chen Zhang, Jiaqiong Li...

https://pubmed.ncbi.nlm.nih.gov/40669898